Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Malignant Salivary Gland Tumors That Have Been Removed By Surgery

NCT01220583 | Active Not Recruiting Phase 2 DMC

• 3 other identifiers: RTOG-1008CDR0000686072NCI-2013-00370
• Study Type: interventional
• Target: 252
• Locations: 3 countries
• Sites: 268

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective when given together with chemotherapy or alone after surgery in treating salivary gland tumors. PURPOSE: This randomized phase II/III trial is studying radiation therapy with or without chemotherapy to see how well it works in treating patients with high-risk malignant salivary gland tumors that have been removed by surgery.

Conditions

Head and Neck Cancer

Keywords

stage I salivary gland cancer; stage II salivary gland cancer; stage III salivary gland cancer; high-grade salivary gland mucoepidermoid carcinoma; salivary gland adenocarcinoma; stage IVA salivary gland cancer; stage IVB salivary gland cancer; stage IVC salivary gland cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS), defined by the events of local-regional progression or recurrence, distant metastasis, or death from any cause, primarily at 2 years

  From randomization to 2 years.

Secondary Outcomes (8)

• Overall survival (OS) rate at 2 years

  From randomization to 2 years.

• PFS rate at 5 years

  From randomization to 5 years.

• OS rate at 5 years

  From randomization to 5 years.

• Treatment-related toxicity, defined as any grade 3-4 adverse events (CTCAE v. 4) deemed to be definitely, probably, or possibly related to protocol treatment

  From start of treatment to last follow-up.

• Treatment-related mortality, defined as any death during or within 30 days of discontinuation of protocol treatment

  From start of treatment to 30 days after the end of treatment.

Study Arms (2)

Arm I

EXPERIMENTAL

Patients undergo 3-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT) 5 days a week for 6-6.5 weeks. Patients also receive cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, 36, and 43 during radiotherapy.

Drug: cisplatin; Radiation: 3-dimensional conformal radiation therapy; Radiation: intensity-modulated radiation therapy

Arm II

EXPERIMENTAL

Patients undergo 3D-CRT or IMRT as in arm I.

Radiation: 3-dimensional conformal radiation therapy; Radiation: intensity-modulated radiation therapy

Interventions

cisplatin DRUG

Given IV

Arm I

3-dimensional conformal radiation therapy RADIATION

Undergo radiotherapy

Arm I; Arm II

intensity-modulated radiation therapy RADIATION

Undergo radiotherapy

Arm I; Arm II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Pathologically proven diagnosis of a malignant major salivary gland tumor or malignant minor salivary gland tumor of the head and neck of the following histologic subtypes: * Intermediate-grade adenocarcinoma or intermediate-grade mucoepidermoid carcinoma * High-grade acinic cell carcinoma or high-grade (\>30% solid component) adenoid cystic carcinoma * Surgical resection with curative intent within 8 weeks prior to registration * All patients must have a Medical Oncology evaluation within 4 weeks prior to registration * Pathologic stage T3-4 or N1-3 or T1-2, N0 with a close (≤ 1mm) or microscopically positive surgical margin; patients must be free of distant metastases based upon the following minimum diagnostic workup: * History/physical examination within 8 weeks prior to registration * Radiologic confirmation of the absence of hematogenous metastasis within 12 weeks prior to registration; at a minimum, contrast CT imaging of the chest is required (PET/CT is acceptable) * No patients with residual macroscopic disease after surgery * No prior systemic chemotherapy or radiation therapy for salivary gland malignancy PATIENT CHARACTERISTICS: * Zubrod performance status 0-1 * Absolute neutrophil count (ANC) ≥ 1,800 cells/mm\^3 * Platelets ≥ 100,000 cells/mm\^3 * Hemoglobin ≥ 8.0 g/dL (the use of transfusion or other intervention to achieve hemoglobin ≥ 8.0 g/dL is acceptable) * Serum creatinine \< 2.0 mg/dL * Total bilirubin \< 2 x the institutional upper limit of normal (ULN) * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \< 3 x the institutional ULN * Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential * Women of childbearing potential and male participants who are sexually active must practice adequate contraception during treatment and for 6 weeks following treatment * Not pregnant or nursing * Patients must be deemed able to comply with the treatment plan and follow-up schedule * Patients must provide study specific informed consent prior to study entry, including consent for mandatory tissue submission for central review * No prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible) * No severe, active co-morbidity, defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months * Transmural myocardial infarction within the last 6 months * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration * Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects (coagulation parameters are not required for entry into this protocol) * Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control (CDC) definition (HIV testing is not required for entry into this protocol) * Protocol-specific requirements may also exclude immunocompromised patients * Pre-existing ≥ grade 2 neuropathy * No significant pre-existing hearing loss, as defined by the patient or treating physician PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior systemic chemotherapy or radiation therapy for salivary gland malignancy (prior chemotherapy for a different cancer is allowable) * No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields * No prior organ transplant * No concurrent hematopoietic growth factors (e.g., G-CSF or pegfilgrastim) during radiotherapy * No concurrent erythropoiesis-stimulating agents

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Radiation Therapy Oncology Group: lead
• National Cancer Institute (NCI): collaborator
• NRG Oncology: collaborator

Study Sites (268)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States

Location

The Kirklin Clinic at Acton Road

Birmingham, Alabama, 35243, United States

Location

Arizona Breast Cancer Specialists-Gilbert

Gilbert, Arizona, 85297, United States

Location

Arizona Center for Cancer Care-Peoria

Peoria, Arizona, 85381, United States

Location

Cancer Center at Saint Joseph's

Phoenix, Arizona, 85004, United States

Location

Arizona Breast Cancer Specialists-Phoenix

Phoenix, Arizona, 85027, United States

Location

Arizona Oncology-Deer Valley Center

Phoenix, Arizona, 85027, United States

Location

Arizona Breast Cancer Specialists

Scottsdale, Arizona, 85251, United States

Location

Arizona Breast Cancer Specialists-Scottsdale

Scottsdale, Arizona, 85258, United States

Location

Arizona Oncology Services Foundation

Scottsdale, Arizona, 85260, United States

Location

Arizona Center for Cancer Care-Surprise

Surprise, Arizona, 85374, United States

Location

University of Arizona Cancer Center-Orange Grove Campus

Tucson, Arizona, 85704, United States

Location

Banner University Medical Center - Tucson

Tucson, Arizona, 85719, United States

Location

University of Arizona Cancer Center-North Campus

Tucson, Arizona, 85719, United States

Location

Sutter Cancer Centers Radiation Oncology Services-Auburn

Auburn, California, 95603, United States

Location

AIS Cancer Center at San Joaquin Community Hospital

Bakersfield, California, 93301, United States

Location

Mills-Peninsula Medical Center

Burlingame, California, 94010, United States

Location

Sutter Cancer Centers Radiation Oncology Services-Cameron Park

Cameron Park, California, 95682, United States

Location

Mercy San Juan Medical Center

Carmichael, California, 95608, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

Los Angeles County-USC Medical Center

Los Angeles, California, 90033, United States

Location

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Fremont - Rideout Cancer Center

Marysville, California, 95901, United States

Location

Memorial Medical Center

Modesto, California, 95355, United States

Location

Hoag Memorial Hospital

Newport Beach, California, 92663, United States

Location

Saint Joseph Hospital - Orange

Orange, California, 92868, United States

Location

Stanford Cancer Institute Palo Alto

Palo Alto, California, 94304, United States

Location

Sutter Cancer Centers Radiation Oncology Services-Roseville

Roseville, California, 95661, United States

Location

Sutter Medical Center Sacramento

Sacramento, California, 95816, United States

Location

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

UCSF Medical Center-Mount Zion

San Francisco, California, 94115, United States

Location

UCSF Medical Center-Mission Bay

San Francisco, California, 94158, United States

Location

Sutter Cancer Centers Radiation Oncology Services-Vacaville

Vacaville, California, 95687, United States

Location

Rocky Mountain Cancer Centers-Aurora

Aurora, Colorado, 80012, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Boulder Community Hospital

Boulder, Colorado, 80301, United States

Location

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, 80907, United States

Location

Porter Adventist Hospital

Denver, Colorado, 80210, United States

Location

Swedish Medical Center

Englewood, Colorado, 80113, United States

Location

Rocky Mountain Cancer Centers-Littleton

Littleton, Colorado, 80120, United States

Location

Longmont United Hospital

Longmont, Colorado, 80501, United States

Location

McKee Medical Center

Loveland, Colorado, 80539, United States

Location

North Suburban Medical Center

Thornton, Colorado, 80229, United States

Location

Rocky Mountain Cancer Centers-Thornton

Thornton, Colorado, 80260, United States

Location

William Backus Hospital

Norwich, Connecticut, 06360, United States

Location

Helen F Graham Cancer Center

Newark, Delaware, 19713, United States

Location

Christiana Care Health System-Christiana Hospital

Newark, Delaware, 19718, United States

Location

Beebe Health Campus

Rehoboth Beach, Delaware, 19971, United States

Location

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, 33146, United States

Location

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, 33442, United States

Location

University of Florida Health Science Center - Gainesville

Gainesville, Florida, 32610, United States

Location

Baptist MD Anderson Cancer Center

Jacksonville, Florida, 32207, United States

Location

University of Florida Health Science Center - Jacksonville

Jacksonville, Florida, 32209, United States

Location

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136, United States

Location

Miami Cancer Institute

Miami, Florida, 33176, United States

Location

Orlando Health Cancer Institute

Orlando, Florida, 32806, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Emory Proton Therapy Center

Atlanta, Georgia, 30308, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Memorial Health University Medical Center

Savannah, Georgia, 31404, United States

Location

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, 83706, United States

Location

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, 83854, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Saint John's Hospital

Springfield, Illinois, 62702, United States

Location

IU Health North Hospital

Carmel, Indiana, 46032, United States

Location

Goshen Center for Cancer Care

Goshen, Indiana, 46526, United States

Location

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Sidney and Lois Eskenazi Hospital

Indianapolis, Indiana, 46202, United States

Location

Memorial Hospital of South Bend

South Bend, Indiana, 46601, United States

Location

McFarland Clinic PC - Ames

Ames, Iowa, 50010, United States

Location

Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

Location

Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314, United States

Location

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States

Location

Siouxland Regional Cancer Center

Sioux City, Iowa, 51101, United States

Location

University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States

Location

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536, United States

Location

The James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, 40202, United States

Location

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, 70809, United States

Location

University Medical Center New Orleans

New Orleans, Louisiana, 70112, United States

Location

Touro Infirmary

New Orleans, Louisiana, 70115, United States

Location

Ochsner Medical Center Jefferson

New Orleans, Louisiana, 70121, United States

Location

Greater Baltimore Medical Center

Baltimore, Maryland, 21204, United States

Location

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Bixby Medical Center

Adrian, Michigan, 49221, United States

Location

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, 48106, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Cancer Institute-Downriver

Brownstown, Michigan, 48183, United States

Location

Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan, 48038, United States

Location

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Ascension Saint John Hospital

Detroit, Michigan, 48236, United States

Location

Weisberg Cancer Treatment Center

Farmington Hills, Michigan, 48334, United States

Location

Genesys Hurley Cancer Institute

Flint, Michigan, 48503, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States

Location

Saint Mary Mercy Hospital

Livonia, Michigan, 48154, United States

Location

Saint Joseph Mercy Oakland

Pontiac, Michigan, 48341, United States

Location

Lake Huron Medical Center

Port Huron, Michigan, 48060, United States

Location

Ascension Saint Mary's Hospital

Saginaw, Michigan, 48601, United States

Location

Saint John Macomb-Oakland Hospital

Warren, Michigan, 48093, United States

Location

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, 48322, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, 63376, United States

Location

University of Missouri - Ellis Fischel

Columbia, Missouri, 65212, United States

Location

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, 63141, United States

Location

Freeman Health System

Joplin, Missouri, 64804, United States

Location

Delbert Day Cancer Institute at PCRMC

Rolla, Missouri, 65401, United States

Location

Mercy Hospital Springfield

Springfield, Missouri, 65804, United States

Location

SSM Health Saint Louis University Hospital

St Louis, Missouri, 63104, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Siteman Cancer Center-South County

St Louis, Missouri, 63129, United States

Location

Billings Clinic Cancer Center

Billings, Montana, 59101, United States

Location

Bozeman Deaconess Hospital

Bozeman, Montana, 59715, United States

Location

Kalispell Regional Medical Center

Kalispell, Montana, 59901, United States

Location

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

Location

Alegent Health Bergan Mercy Medical Center

Omaha, Nebraska, 68124, United States

Location

Comprehensive Cancer Centers of Nevada - Henderson

Henderson, Nevada, 89052, United States

Location

Radiation Oncology Centers of Nevada Central

Las Vegas, Nevada, 89106, United States

Location

Comprehensive Cancer Centers of Nevada - Northwest

Las Vegas, Nevada, 89128, United States

Location

Comprehensive Cancer Centers of Nevada-Summerlin

Las Vegas, Nevada, 89144, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89148, United States

Location

Comprehensive Cancer Centers of Nevada - Central Valley

Las Vegas, Nevada, 89169, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States

Location

Virtua Memorial

Mount Holly, New Jersey, 08060, United States

Location

Rutgers New Jersey Medical School

Newark, New Jersey, 07101, United States

Location

Sparta Cancer Treatment Center

Sparta, New Jersey, 07871, United States

Location

Virtua Voorhees

Voorhees Township, New Jersey, 08043, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87102, United States

Location

Northwell Health Imbert Cancer Center

Bay Shore, New York, 11706, United States

Location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

East White Plains, New York, 10604, United States

Location

Northwell Health/Center for Advanced Medicine

Lake Success, New York, 11042, United States

Location

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

Location

Mount Sinai Union Square

New York, New York, 10003, United States

Location

Mount Sinai Chelsea

New York, New York, 10011, United States

Location

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, 10016, United States

Location

Lenox Hill Hospital

New York, New York, 10021, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Highland Hospital

Rochester, New York, 14620, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Memorial Sloan Kettering Sleepy Hollow

Sleepy Hollow, New York, 10591, United States

Location

State University of New York Upstate Medical University

Syracuse, New York, 13210, United States

Location

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

Location

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Summa Health System - Akron Campus

Akron, Ohio, 44304, United States

Location

Summa Health System - Barberton Campus

Barberton, Ohio, 44203, United States

Location

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, 45219, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Mercy Cancer Center-Elyria

Elyria, Ohio, 44035, United States

Location

Summa Health Medina Medical Center

Medina, Ohio, 44256, United States

Location

UH Seidman Cancer Center at Lake Health Mentor Campus

Mentor, Ohio, 44060, United States

Location

UH Seidman Cancer Center at Southwest General Hospital

Middleburg Heights, Ohio, 44130, United States

Location

University Hospitals Parma Medical Center

Parma, Ohio, 44129, United States

Location

UH Seidman Cancer Center at Salem Regional Medical Center

Salem, Ohio, 44460, United States

Location

UH Seidman Cancer Center at Firelands Regional Medical Center

Sandusky, Ohio, 44870, United States

Location

ProMedica Flower Hospital

Sylvania, Ohio, 43560, United States

Location

University of Toledo

Toledo, Ohio, 43614, United States

Location

Mercy Health - Saint Anne Hospital

Toledo, Ohio, 43623, United States

Location

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, 45069, United States

Location

Cancer Treatment Center

Wooster, Ohio, 44691, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Mercy Hospital Oklahoma City

Oklahoma City, Oklahoma, 73120, United States

Location

Clackamas Radiation Oncology Center

Clackamas, Oregon, 97015, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Providence Saint Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, 18103, United States

Location

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, 19010, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

UPMC Cancer Centers - Arnold Palmer Pavilion

Greensburg, Pennsylvania, 15601, United States

Location

UPMC Pinnacle Cancer Center/Community Osteopathic Campus

Harrisburg, Pennsylvania, 17109, United States

Location

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

Geisinger Medical Oncology-Lewisburg

Lewisburg, Pennsylvania, 17837, United States

Location

Lewistown Hospital

Lewistown, Pennsylvania, 17044, United States

Location

UPMC-Coraopolis/Heritage Valley Radiation Oncology

Moon Township, Pennsylvania, 15108, United States

Location

UPMC Jameson

New Castle, Pennsylvania, 16105, United States

Location

Paoli Memorial Hospital

Paoli, Pennsylvania, 19301, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

UPMC-Saint Margaret

Pittsburgh, Pennsylvania, 15215, United States

Location

UPMC-Shadyside Hospital

Pittsburgh, Pennsylvania, 15232, United States

Location

UPMC Jefferson Regional Radiation Oncology

Pittsburgh, Pennsylvania, 15236, United States

Location

UPMC-Passavant Hospital

Pittsburgh, Pennsylvania, 15237, United States

Location

UPMC-Saint Clair Hospital Cancer Center

Pittsburgh, Pennsylvania, 15243, United States

Location

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, 18711, United States

Location

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

Location

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, 29316, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, 29605, United States

Location

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, 29615, United States

Location

Prisma Health Cancer Institute - Greer

Greer, South Carolina, 29650, United States

Location

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, 29672, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57701, United States

Location

University of Tennessee - Knoxville

Knoxville, Tennessee, 37920, United States

Location

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

MD Anderson in The Woodlands

Conroe, Texas, 77384, United States

Location

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MD Anderson West Houston

Houston, Texas, 77079, United States

Location

MD Anderson League City

League City, Texas, 77573, United States

Location

MD Anderson in Sugar Land

Sugar Land, Texas, 77478, United States

Location

American Fork Hospital / Huntsman Intermountain Cancer Center

American Fork, Utah, 84003, United States

Location

Sandra L Maxwell Cancer Center

Cedar City, Utah, 84720, United States

Location

Logan Regional Hospital

Logan, Utah, 84321, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

Utah Valley Regional Medical Center

Provo, Utah, 84604, United States

Location

Utah Cancer Specialists-Salt Lake City

Salt Lake City, Utah, 84106, United States

Location

Dixie Medical Center Regional Cancer Center

St. George, Utah, 84770, United States

Location

Norris Cotton Cancer Center-North

Saint Johnsbury, Vermont, 05819, United States

Location

Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Sentara Cancer Institute at Sentara CarePlex Hospital

Hampton, Virginia, 23666, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Sentara Virginia Beach General Hospital

Virginia Beach, Virginia, 23454, United States

Location

Saint Francis Hospital

Federal Way, Washington, 98003, United States

Location

Seattle Cancer Care Alliance at Northwest Hospital

Seattle, Washington, 98133, United States

Location

University of Washington Medical Center - Montlake

Seattle, Washington, 98195, United States

Location

PeaceHealth Southwest Medical Center

Vancouver, Washington, 98664, United States

Location

Compass Oncology Vancouver

Vancouver, Washington, 98684, United States

Location

West Virginia University Healthcare

Morgantown, West Virginia, 26506, United States

Location

Wheeling Hospital/Schiffler Cancer Center

Wheeling, West Virginia, 26003, United States

Location

Aurora Cancer Care-Southern Lakes VLCC

Burlington, Wisconsin, 53105, United States

Location

Aurora Health Center-Fond du Lac

Fond du Lac, Wisconsin, 54937, United States

Location

Aurora Health Care Germantown Health Center

Germantown, Wisconsin, 53022, United States

Location

Aurora Cancer Care-Grafton

Grafton, Wisconsin, 53024, United States

Location

Green Bay Oncology at Saint Vincent Hospital

Green Bay, Wisconsin, 54301-3526, United States

Location

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, 54301, United States

Location

Saint Vincent Hospital Cancer Center at Saint Mary's

Green Bay, Wisconsin, 54303, United States

Location

Aurora BayCare Medical Center

Green Bay, Wisconsin, 54311, United States

Location

Aurora Cancer Care-Kenosha South

Kenosha, Wisconsin, 53142, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Aurora Bay Area Medical Group-Marinette

Marinette, Wisconsin, 54143, United States

Location

Bay Area Medical Center

Marinette, Wisconsin, 54143, United States

Location

Aurora Cancer Care-Milwaukee

Milwaukee, Wisconsin, 53209, United States

Location

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Vince Lombardi Cancer Clinic - Oshkosh

Oshkosh, Wisconsin, 54904, United States

Location

Aurora Cancer Care-Racine

Racine, Wisconsin, 53406, United States

Location

Vince Lombardi Cancer Clinic-Sheboygan

Sheboygan, Wisconsin, 53081, United States

Location

Saint Vincent Hospital Cancer Center at Sturgeon Bay

Sturgeon Bay, Wisconsin, 54235-1495, United States

Location

Aurora Medical Center in Summit

Summit, Wisconsin, 53066, United States

Location

Vince Lombardi Cancer Clinic-Two Rivers

Two Rivers, Wisconsin, 54241, United States

Location

Aurora Cancer Care-Milwaukee West

Wauwatosa, Wisconsin, 53226, United States

Location

Aurora West Allis Medical Center

West Allis, Wisconsin, 53227, United States

Location

Aspirus Cancer Care - Wisconsin Rapids

Wisconsin Rapids, Wisconsin, 54494, United States

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

Health Sciences North

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

London Regional Cancer Program

London, Ontario, N6A 4L6, Canada

Location

University Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

CHUM - Hopital Notre-Dame

Montreal, Quebec, H2L 4M1, Canada

Location

McGill University Department of Oncology

Montreal, Quebec, H2W 1S6, Canada

Location

CHUM - Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2X 3E4, Canada

Location

The Research Institute of the McGill University Health Centre (MUHC)

Montreal, Quebec, H3H 2R9, Canada

Location

King Faisal Specialist Hospital and Research Centre

Riyadh, 11211, Saudi Arabia

Location

Related Publications (1)

• Joshi NP, Broughman JR. Postoperative Management of Salivary Gland Tumors. Curr Treat Options Oncol. 2021 Feb 9;22(3):23. doi: 10.1007/s11864-021-00820-9.

  PMID: 33560478 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms; Salivary Gland Neoplasms

Interventions

Cisplatin; Radiotherapy, Conformal; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Mouth Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Cristina P. Rodriguez, MD

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2010
• First Posted: October 14, 2010
• Study Start: January 1, 2011
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 1, 2028
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

SA (1); US (259); CA (8)