Gemcitabine and Cisplatin Without Cystectomy for Patients With Muscle Invasive Bladder Urothelial Cancer and Select Genetic Alterations
A Phase II Study of Gemcitabine Plus Cisplatin Chemotherapy in Patients With Muscle-invasive Bladder Cancer With Bladder Preservation for Those Patients Whose Tumors Harbor Deleterious DNA Damage Response (DDR) Gene Alterations
3 other identifiers
interventional
237
1 country
424
Brief Summary
This phase II trial studies how well gemcitabine hydrochloride and cisplatin work in treating participants with invasive bladder urothelial cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2018
Longer than P75 for phase_2
424 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2018
CompletedFirst Posted
Study publicly available on registry
August 1, 2018
CompletedStudy Start
First participant enrolled
December 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2029
April 13, 2026
April 1, 2026
8.2 years
July 25, 2018
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of patients who are recurrence-free within the DDR mutated group who undergo the bladder sparing approach
Will use Kaplan Meier survival analysis to estimate the proportion of patients who are recurrence-free at three years. Will use a one-sided 90% confidence interval.
At 3 years
Secondary Outcomes (7)
Clinical response rate for patients harboring deleterious DDR gene alterations
After 6 courses (84 days)
Bladder-intact survival in DDR-altered patients with < cT1 responses who selected the bladder sparing approach
Time from registration up to 5 years
Overall survival
Time from study registration up to 5 years
Pathologic response (pT0) rate at cystectomy in participants without DDR gene alterations
Up to 5 years
Recurrence-free survival
Time from study registration up to 5 years
- +2 more secondary outcomes
Study Arms (2)
Arm I (gemcitabine, cisplatin, bladder sparing)
EXPERIMENTALParticipants receive gemcitabine hydrochloride IV over 30 minutes on day 1, cisplatin IV on days 1 and 2, and pegfilgrastim SC on day 3. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unaccepted toxicity. Participants with DDR gene alteration and disease stage \< cT1 undergo bladder sparing.
Arm II (gemcitabine, cisplatin, cystectomy, chemoradiotherapy)
EXPERIMENTALParticipants receive gemcitabine hydrochloride IV over 30 minutes on day 1, cisplatin IV on days 1 and 2, and pegfilgrastim SC on day 3. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unaccepted toxicity. Participants with DDR gene alteration and disease stage \>= cT1 or participants without DDR gene alteration undergo radical cystectomy or chemoradiotherapy.
Interventions
Given IV
Given IV
Undergo radical cystectomy
Undergo chemoradiotherapy
Given SC
Eligibility Criteria
You may qualify if:
- Step 1 Patient Registration Eligibility Criteria
- Histologically confirmed muscle-invasive urothelial carcinoma of the bladder. Urothelial carcinoma invading into the prostatic stroma with no histologic muscle invasion is allowed, provided the extent of disease is confirmed via imaging and/or examination under anesthesia (EUA). The diagnostic TURBT sample must have been obtained within 60 days prior to registration
- unstained slides (10 micron thickness) of formalin-fixed paraffin-embedded (FFPE) pre-treatment diagnostic transurethral resection (TUR) specimen available (for sequencing), with 2 (5 micron) slides at the start and end of the 20 slides, for a total of 22 unstained slides. An FFPE block is also acceptable
- Clinical stage T2-T4aN0/xM0 disease
- Medically appropriate candidate for radical cystectomy as assessed by surgeon
- No concomitant multifocal carcinoma in situ; a single focus is allowed
- A single muscle-invasive bladder tumor measuring ≤5 cm in size as defined by the surgeons at cystoscopic evaluation. When documented, pathologic size at cystoscopy and TURBT will take precedence over radiographic measurements of tumor size.
- No clinical or radiographic evidence for locally advanced or metastatic disease
- No prior anti-PD-1 or anti PD-L1 therapies, or systemic chemotherapy within the past 5 years (prior intravesical induction immunotherapy for non-muscle invasive disease is allowed, defined as BCG x6 doses and maintenance therapy); BCG refractory disease, defined as disease recurrence within 3 months of BCG therapy, is not allowed. Intravesical chemotherapy is allowed.
- No prior radiation therapy to the bladder or prostate
- No major surgery or radiation therapy =\< 4 weeks of registration (TURBT is allowed).
- Not pregnant and not nursing. This study involves an agent that has known genotoxic, mutagenic and teratogenic effects. For women of childbearing potential only, a negative pregnancy test done =\< 14 days prior to registration is required
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Absolute neutrophil count (ANC) \>= 1,000/mm\^3
- Platelet count \>= 100,000/mm\^3
- +20 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (424)
Fairbanks Memorial Hospital
Fairbanks, Alaska, 99701, United States
CTCA at Western Regional Medical Center
Goodyear, Arizona, 85338, United States
Cancer Center at Saint Joseph's
Phoenix, Arizona, 85004, United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903, United States
CHI Saint Vincent Cancer Center Hot Springs
Hot Springs, Arkansas, 71913, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California, 93420, United States
Mercy Cancer Center - Carmichael
Carmichael, California, 95608, United States
Mercy San Juan Medical Center
Carmichael, California, 95608, United States
Mercy Cancer Center - Elk Grove
Elk Grove, California, 95758, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
Contra Costa Regional Medical Center
Martinez, California, 94553-3156, United States
Fremont - Rideout Cancer Center
Marysville, California, 95901, United States
Mercy Cancer Center
Merced, California, 95340, United States
Mercy Cancer Center - Rocklin
Rocklin, California, 95765, United States
Mercy Cancer Center - Sacramento
Sacramento, California, 95816, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo, California, 93401, United States
Mission Hope Medical Oncology - Santa Maria
Santa Maria, California, 93444, United States
Saint Joseph's Medical Center
Stockton, California, 95204, United States
BASS Medical Group - Lennon
Walnut Creek, California, 94598, United States
Woodland Memorial Hospital
Woodland, California, 95695, United States
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, 80012, United States
The Medical Center of Aurora
Aurora, Colorado, 80012, United States
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, 80304, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907, United States
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, 80907, United States
Saint Francis Cancer Center
Colorado Springs, Colorado, 80923, United States
AdventHealth Porter
Denver, Colorado, 80210, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218, United States
CommonSpirit Cancer Center Mercy
Durango, Colorado, 81301, United States
Mercy Medical Center
Durango, Colorado, 81301, United States
Mountain Blue Cancer Care Center - Swedish
Englewood, Colorado, 80113, United States
Swedish Medical Center
Englewood, Colorado, 80113, United States
The Melanoma and Skin Cancer Institute
Englewood, Colorado, 80113, United States
Mountain Blue Cancer Care Center
Golden, Colorado, 80401, United States
Banner North Colorado Medical Center
Greeley, Colorado, 80631, United States
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado, 80228, United States
Saint Anthony Hospital
Lakewood, Colorado, 80228, United States
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, 80120, United States
AdventHealth Littleton
Littleton, Colorado, 80122, United States
Sky Ridge Medical Center
Lone Tree, Colorado, 80124, United States
Longmont United Hospital
Longmont, Colorado, 80501, United States
Rocky Mountain Cancer Centers-Longmont
Longmont, Colorado, 80501, United States
Banner North Colorado Medical Center - Loveland Campus
Loveland, Colorado, 80539, United States
AdventHealth Parker
Parker, Colorado, 80138, United States
Rocky Mountain Cancer Centers-Parker
Parker, Colorado, 80138, United States
Saint Mary Corwin Medical Center
Pueblo, Colorado, 81004, United States
Rocky Mountain Cancer Centers - Pueblo
Pueblo, Colorado, 81008, United States
Rocky Mountain Cancer Centers-Thornton
Thornton, Colorado, 80260, United States
Saint Anthony North Hospital
Westminster, Colorado, 80023, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
Midstate Medical Center
Meriden, Connecticut, 06451, United States
The Hospital of Central Connecticut
New Britain, Connecticut, 06050, United States
William Backus Hospital
Norwich, Connecticut, 06360, United States
Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
UF Health Cancer Institute - Gainesville
Gainesville, Florida, 32610, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706, United States
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605, United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814, United States
Walter Knox Memorial Hospital
Emmett, Idaho, 83617, United States
Idaho Urologic Institute-Meridian
Meridian, Idaho, 83642, United States
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, 83687, United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854, United States
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, 83864, United States
OSF Saint Anthony's Health Center
Alton, Illinois, 62002, United States
Rush-Copley Medical Center
Aurora, Illinois, 60504, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704, United States
Illinois CancerCare-Canton
Canton, Illinois, 61520, United States
Memorial Hospital of Carbondale
Carbondale, Illinois, 62902, United States
SIH Cancer Institute
Carterville, Illinois, 62918, United States
Illinois CancerCare-Carthage
Carthage, Illinois, 62321, United States
Centralia Oncology Clinic
Centralia, Illinois, 62801, United States
Saint Mary's Hospital
Centralia, Illinois, 62801, United States
University of Illinois
Chicago, Illinois, 60612, United States
Carle at The Riverfront
Danville, Illinois, 61832, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Illinois CancerCare-Dixon
Dixon, Illinois, 61021, United States
Carle Physician Group-Effingham
Effingham, Illinois, 62401, United States
Crossroads Cancer Center
Effingham, Illinois, 62401, United States
Illinois CancerCare-Eureka
Eureka, Illinois, 61530, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401, United States
Western Illinois Cancer Treatment Center
Galesburg, Illinois, 61401, United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443, United States
Illinois CancerCare-Macomb
Macomb, Illinois, 61455, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938, United States
SSM Health Good Samaritan
Mount Vernon, Illinois, 62864, United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269, United States
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois, 62269, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350, United States
Illinois CancerCare-Pekin
Pekin, Illinois, 61554, United States
OSF Saint Francis Radiation Oncology at Pekin
Pekin, Illinois, 61554, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636, United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
Illinois CancerCare-Peru
Peru, Illinois, 61354, United States
Valley Radiation Oncology
Peru, Illinois, 61354, United States
Illinois CancerCare-Princeton
Princeton, Illinois, 61356, United States
UW Health Carbone Cancer Center Rockford
Rockford, Illinois, 61114, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
Springfield Clinic
Springfield, Illinois, 62702, United States
Springfield Memorial Hospital
Springfield, Illinois, 62781, United States
Southwest Illinois Health Services LLP
Swansea, Illinois, 62226, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
The Carle Foundation Hospital
Urbana, Illinois, 61801, United States
Illinois CancerCare - Washington
Washington, Illinois, 61571, United States
Reid Health
Richmond, Indiana, 47374, United States
Saint Anthony Regional Hospital
Carroll, Iowa, 51401, United States
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325, United States
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325, United States
Alegent Health Mercy Hospital
Council Bluffs, Iowa, 51503, United States
Greater Regional Medical Center
Creston, Iowa, 50801, United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309, United States
Broadlawns Medical Center
Des Moines, Iowa, 50314, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314, United States
Iowa Lutheran Hospital
Des Moines, Iowa, 50316, United States
UI Healthcare Mission Cancer and Blood - Fort Dodge
Fort Dodge, Iowa, 50501, United States
Methodist West Hospital
West Des Moines, Iowa, 50266-7700, United States
Mercy Medical Center-West Lakes
West Des Moines, Iowa, 50266, United States
Central Care Cancer Center - Garden City
Garden City, Kansas, 67846, United States
Central Care Cancer Center - Great Bend
Great Bend, Kansas, 67530, United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160, United States
Mercy Hospital Pittsburg
Pittsburg, Kansas, 66762, United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, 66205, United States
Flaget Memorial Hospital
Bardstown, Kentucky, 40004, United States
Commonwealth Cancer Center-Corbin
Corbin, Kentucky, 40701, United States
Saint Joseph Hospital
Lexington, Kentucky, 40504, United States
Saint Joseph Radiation Oncology Resource Center
Lexington, Kentucky, 40504, United States
Saint Joseph Hospital East
Lexington, Kentucky, 40509, United States
Saint Joseph London
London, Kentucky, 40741, United States
Jewish Hospital
Louisville, Kentucky, 40202, United States
Saints Mary and Elizabeth Hospital
Louisville, Kentucky, 40215, United States
UofL Health Medical Center Northeast
Louisville, Kentucky, 40245, United States
Jewish Hospital Medical Center South
Shepherdsville, Kentucky, 40165, United States
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana, 70805, United States
Our Lady of the Lake Physician Group
Baton Rouge, Louisiana, 70808, United States
Our Lady of The Lake
Baton Rouge, Louisiana, 70808, United States
Louisiana Hematology Oncology Associates LLC
Baton Rouge, Louisiana, 70809, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809, United States
Northshore Oncology Associates-Covington
Covington, Louisiana, 70433, United States
Terrebonne General Medical Center
Houma, Louisiana, 70360, United States
Mary Bird Perkins Cancer Center - Metairie
Metairie, Louisiana, 70002, United States
East Jefferson General Hospital
Metairie, Louisiana, 70006, United States
LSU Healthcare Network / Metairie Multi-Specialty Clinic
Metairie, Louisiana, 70006, United States
Louisiana State University Health Science Center
New Orleans, Louisiana, 70112, United States
University Medical Center New Orleans
New Orleans, Louisiana, 70112, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121, United States
Maryland Proton Treatment Center
Baltimore, Maryland, 21201, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Central Maryland Radiation Oncology in Howard County
Columbia, Maryland, 21044, United States
UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie, Maryland, 21061, United States
Mercy Medical Center
Springfield, Massachusetts, 01104, United States
MyMichigan Medical Center Gratiot
Alma, Michigan, 48801, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106, United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114, United States
Trinity Health Medical Center - Brighton
Brighton, Michigan, 48114, United States
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188, United States
Trinity Health Medical Center - Canton
Canton, Michigan, 48188, United States
Caro Cancer Center
Caro, Michigan, 48723, United States
Chelsea Hospital
Chelsea, Michigan, 48118, United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118, United States
Hematology Oncology Consultants-Clarkston
Clarkston, Michigan, 48346, United States
Newland Medical Associates-Clarkston
Clarkston, Michigan, 48346, United States
Henry Ford Health Saint John Hospital
Detroit, Michigan, 48236, United States
Henry Ford River District Hospital
East China Township, Michigan, 48054, United States
Cancer Hematology Centers - Flint
Flint, Michigan, 48503, United States
Genesee Hematology Oncology PC
Flint, Michigan, 48503, United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503, United States
Hurley Medical Center
Flint, Michigan, 48503, United States
Henry Ford Saint John Hospital - Academic
Grosse Pointe Woods, Michigan, 48236, United States
Henry Ford Saint John Hospital - Breast
Grosse Pointe Woods, Michigan, 48236, United States
Henry Ford Saint John Hospital - Van Elslander
Grosse Pointe Woods, Michigan, 48236, United States
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912, United States
Hope Cancer Clinic
Livonia, Michigan, 48154, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154, United States
Henry Ford Saint John Hospital - Macomb Medical
Macomb, Michigan, 48044, United States
Henry Ford Warren Hospital - Breast Macomb
Macomb, Michigan, 48044, United States
Saint Mary's Oncology/Hematology Associates of Marlette
Marlette, Michigan, 48453, United States
MyMichigan Medical Center Midland
Midland, Michigan, 48670, United States
Hope Cancer Center
Pontiac, Michigan, 48341, United States
Michigan Healthcare Professionals Pontiac
Pontiac, Michigan, 48341, United States
Newland Medical Associates-Pontiac
Pontiac, Michigan, 48341, United States
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341, United States
Henry Ford Rochester Hospital
Rochester Hills, Michigan, 48309, United States
MyMichigan Medical Center Saginaw
Saginaw, Michigan, 48601, United States
Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan, 48604, United States
Bhadresh Nayak MD PC-Sterling Heights
Sterling Heights, Michigan, 48312, United States
MyMichigan Medical Center Tawas
Tawas City, Michigan, 48764, United States
Advanced Breast Care Center PLLC
Warren, Michigan, 48088, United States
Henry Ford Health Warren Hospital
Warren, Michigan, 48093, United States
Henry Ford Madison Heights Hospital - Breast
Warren, Michigan, 48093, United States
Henry Ford Warren Hospital - GLCMS
Warren, Michigan, 48093, United States
Macomb Hematology Oncology PC
Warren, Michigan, 48093, United States
Saint Mary's Oncology/Hematology Associates of West Branch
West Branch, Michigan, 48661, United States
Huron Gastroenterology PC
Ypsilanti, Michigan, 48106, United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, 48197, United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601, United States
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636, United States
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes, Minnesota, 56501, United States
Essentia Health Cancer Center
Duluth, Minnesota, 55805, United States
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, 55805, United States
Miller-Dwan Hospital
Duluth, Minnesota, 55805, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Lake Region Healthcare Corporation-Cancer Care
Fergus Falls, Minnesota, 56537, United States
Essentia Health - Fosston
Fosston, Minnesota, 56542, United States
Unity Hospital
Fridley, Minnesota, 55432, United States
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746, United States
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota, 55369, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
Health Partners Inc
Minneapolis, Minnesota, 55454, United States
Monticello Cancer Center
Monticello, Minnesota, 55362, United States
New Ulm Medical Center
New Ulm, Minnesota, 56073, United States
Essentia Health - Park Rapids
Park Rapids, Minnesota, 56470, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422, United States
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, 56303, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Essentia Health Sandstone
Sandstone, Minnesota, 55072, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379, United States
Lakeview Hospital
Stillwater, Minnesota, 55082, United States
Sanford Thief River Falls Medical Center
Thief River Falls, Minnesota, 56701, United States
Essentia Health Virginia Clinic
Virginia, Minnesota, 55792, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Rice Memorial Hospital
Willmar, Minnesota, 56201, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125, United States
Sanford Cancer Center Worthington
Worthington, Minnesota, 56187, United States
Fairview Lakes Medical Center
Wyoming, Minnesota, 55092, United States
Mercy Oncology and Hematology - Clayton-Clarkson
Ballwin, Missouri, 63011, United States
Central Care Cancer Center - Bolivar
Bolivar, Missouri, 65613, United States
Parkland Health Center-Bonne Terre
Bonne Terre, Missouri, 63628, United States
Mercy Cancer Center - Cape Girardeau
Cape Girardeau, Missouri, 63703, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
MU Health - University Hospital/Ellis Fischel Cancer Center
Columbia, Missouri, 65212, United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141, United States
Parkland Health Center - Farmington
Farmington, Missouri, 63640, United States
MU Health Care Goldschmidt Cancer Center
Jefferson City, Missouri, 65109, United States
Freeman Health System
Joplin, Missouri, 64804, United States
Mercy Hospital Joplin
Joplin, Missouri, 64804, United States
Lake Regional Hospital
Osage Beach, Missouri, 65065, United States
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, 65401, United States
Phelps Health Delbert Day Cancer Institute
Rolla, Missouri, 65401, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506, United States
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
CoxHealth South Hospital
Springfield, Missouri, 65807, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Mercy Hospital South
St Louis, Missouri, 63128, United States
Siteman Cancer Center-South County
St Louis, Missouri, 63129, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, 63136, United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141, United States
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080, United States
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri, 63127, United States
Community Hospital of Anaconda
Anaconda, Montana, 59711, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715, United States
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405, United States
Great Falls Clinic
Great Falls, Montana, 59405, United States
Hi-Line Sletten Cancer Center
Havre, Montana, 59501, United States
Saint Peter's Community Hospital
Helena, Montana, 59601, United States
Logan Health Medical Center
Kalispell, Montana, 59901, United States
Community Medical Center
Missoula, Montana, 59804, United States
Nebraska Cancer Specialists/Oncology Hematology West PC
Grand Island, Nebraska, 68803, United States
Fred and Pamela Buffett Cancer Center - Kearney
Kearney, Nebraska, 68845, United States
CHI Health Good Samaritan
Kearney, Nebraska, 68847, United States
Saint Elizabeth Regional Medical Center
Lincoln, Nebraska, 68510, United States
Alegent Health Immanuel Medical Center
Omaha, Nebraska, 68122, United States
Hematology and Oncology Consultants PC
Omaha, Nebraska, 68122, United States
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, 68124, United States
Alegent Health Lakeside Hospital
Omaha, Nebraska, 68130, United States
Creighton University Medical Center
Omaha, Nebraska, 68131, United States
Midlands Community Hospital
Papillion, Nebraska, 68046, United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Englewood Hospital and Medical Center
Englewood, New Jersey, 07631, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
NYP/Weill Cornell Medical Center
New York, New York, 10065, United States
Upstate Cancer Center at Oswego
Oswego, New York, 13126, United States
Upstate Cancer Center Radiation Oncology at Oswego
Oswego, New York, 13126, United States
University of Rochester
Rochester, New York, 14642, United States
State University of New York Upstate Medical University
Syracuse, New York, 13210, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
Upstate Cancer Center at Verona
Verona, New York, 13478, United States
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, 28328, United States
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, 27534, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, 27534, United States
Onslow Memorial Hospital
Jacksonville, North Carolina, 28546, United States
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina, 28546, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501, United States
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, 58103, United States
Sanford South University Medical Center
Fargo, North Dakota, 58103, United States
Sanford Medical Center Fargo
Fargo, North Dakota, 58104, United States
Sanford Broadway Medical Center
Fargo, North Dakota, 58122, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122, United States
Essentia Health - Jamestown Clinic
Jamestown, North Dakota, 58401, United States
Indu and Raj Soin Medical Center
Beavercreek, Ohio, 45431, United States
Saint Elizabeth Boardman Hospital
Boardman, Ohio, 44512, United States
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, 45459, United States
Miami Valley Hospital South
Centerville, Ohio, 45459, United States
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220, United States
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, 45236, United States
Bethesda North Hospital
Cincinnati, Ohio, 45242, United States
TriHealth Cancer Institute-Westside
Cincinnati, Ohio, 45247, United States
TriHealth Cancer Institute-Anderson
Cincinnati, Ohio, 45255, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Good Samaritan Hospital - Dayton
Dayton, Ohio, 45406, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Premier Blood and Cancer Center
Dayton, Ohio, 45409, United States
Dayton Physician LLC - Englewood
Dayton, Ohio, 45415, United States
Miami Valley Hospital North
Dayton, Ohio, 45415, United States
Armes Family Cancer Center
Findlay, Ohio, 45840, United States
Blanchard Valley Hospital
Findlay, Ohio, 45840, United States
Orion Cancer Care
Findlay, Ohio, 45840, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066, United States
Dayton Physicians LLC-Atrium
Franklin, Ohio, 45005, United States
Dayton Physicians LLC-Wayne
Greenville, Ohio, 45331, United States
Miami Valley Cancer Care and Infusion
Greenville, Ohio, 45331, United States
Wayne Hospital
Greenville, Ohio, 45331, United States
Greater Dayton Cancer Center
Kettering, Ohio, 45409, United States
First Dayton Cancer Care
Kettering, Ohio, 45420, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
Springfield Regional Cancer Center
Springfield, Ohio, 45504, United States
Springfield Regional Medical Center
Springfield, Ohio, 45504, United States
Dayton Physicians LLC - Troy
Troy, Ohio, 45373, United States
Upper Valley Medical Center
Troy, Ohio, 45373, United States
Saint Joseph Warren Hospital
Warren, Ohio, 44484, United States
Saint Elizabeth Youngstown Hospital
Youngstown, Ohio, 44501, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, 73120, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, 74146, United States
Saint Alphonsus Cancer Care Center-Baker City
Baker City, Oregon, 97814, United States
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon, 97914, United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103, United States
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Pocono Medical Center
East Stroudsburg, Pennsylvania, 18301, United States
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, 18201, United States
Lehigh Valley Hospital-Hazleton
Hazleton, Pennsylvania, 18201, United States
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, 17837, United States
Lewistown Hospital
Lewistown, Pennsylvania, 17044, United States
Geisinger Cancer Services-Pottsville
Pottsville, Pennsylvania, 17901, United States
Community Medical Center
Scranton, Pennsylvania, 18510, United States
Geisinger Medical Oncology-Selinsgrove
Selinsgrove, Pennsylvania, 17870, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Prisma Health Cancer Institute - Laurens
Clinton, South Carolina, 29325, United States
Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640, United States
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, 29341, United States
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605, United States
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615, United States
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650, United States
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651, United States
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, 29672, United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303, United States
SMC Center for Hematology Oncology Union
Union, South Carolina, 29379, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134, United States
Memorial Hospital
Chattanooga, Tennessee, 37404, United States
Pulmonary Medicine Center of Chattanooga-Hixson
Hixson, Tennessee, 37343, United States
Memorial GYN Plus
Ooltewah, Tennessee, 37363, United States
Saint Joseph Regional Cancer Center
Bryan, Texas, 77802, United States
Parkland Memorial Hospital
Dallas, Texas, 75235, United States
UT Southwestern Simmons Cancer Center - RedBird
Dallas, Texas, 75237, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390, United States
UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth, Texas, 76104, United States
UT Southwestern Clinical Center at Richardson/Plano
Richardson, Texas, 75080, United States
Highline Medical Center-Main Campus
Burien, Washington, 98166, United States
Saint Elizabeth Hospital
Enumclaw, Washington, 98022, United States
Saint Francis Hospital
Federal Way, Washington, 98003, United States
Saint Clare Hospital
Lakewood, Washington, 98499, United States
Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo, Washington, 98370, United States
Saint Michael Cancer Center
Silverdale, Washington, 98383, United States
Franciscan Research Center-Northwest Medical Plaza
Tacoma, Washington, 98405, United States
Northwest Medical Specialties PLLC
Tacoma, Washington, 98405, United States
United Hospital Center
Bridgeport, West Virginia, 26330, United States
WVUH-Berkely Medical Center
Martinsburg, West Virginia, 25401, United States
West Virginia University Healthcare
Morgantown, West Virginia, 26506, United States
Camden Clark Medical Center
Parkersburg, West Virginia, 26101, United States
Langlade Hospital and Cancer Center
Antigo, Wisconsin, 54409, United States
Duluth Clinic Ashland
Ashland, Wisconsin, 54806, United States
Northwest Wisconsin Cancer Center
Ashland, Wisconsin, 54806, United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701, United States
Essentia Health-Hayward Clinic
Hayward, Wisconsin, 54843, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
Marshfield Medical Center - Ladysmith
Ladysmith, Wisconsin, 54848, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449, United States
Aspirus Medford Hospital
Medford, Wisconsin, 54451, United States
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, 54548, United States
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017, United States
Aspirus Cancer Care - James Beck Cancer Center
Rhinelander, Wisconsin, 54501, United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868, United States
Essentia Health-Spooner Clinic
Spooner, Wisconsin, 54801, United States
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin, 54481, United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482, United States
Essentia Health Saint Mary's Hospital - Superior
Superior, Wisconsin, 54880, United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, 54401, United States
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476, United States
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, 54494, United States
Memorial Hospital of Laramie County
Cheyenne, Wyoming, 82001, United States
Billings Clinic-Cody
Cody, Wyoming, 82414, United States
Welch Cancer Center
Sheridan, Wyoming, 82801, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Gopa Iyer, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2018
First Posted
August 1, 2018
Study Start
December 10, 2018
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2029
Last Updated
April 13, 2026
Record last verified: 2026-04