ROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer Patients
ROMAN: Reduction in Oral Mucositis With Avasopasem Manganese (GC4419) - Phase 3 Trial in Patients Receiving Chemoradiotherapy for Locally-Advanced, Non-Metastatic Head and Neck Cancer
1 other identifier
interventional
455
3 countries
97
Brief Summary
The purpose of the phase 3, clinical study is to determine if GC4419 (avasopasem manganese) administered prior to intensity-modulated radiation therapy (IMRT) reduces the severity of radiation induced oral mucositis in patients who have been diagnosed with locally advanced, non-metastatic squamous cell carcinoma of the head and neck.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2018
Longer than P75 for phase_3
97 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2018
CompletedFirst Posted
Study publicly available on registry
September 28, 2018
CompletedStudy Start
First participant enrolled
October 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 13, 2021
CompletedResults Posted
Study results publicly available
April 13, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 25, 2023
CompletedOctober 24, 2023
October 1, 2023
2.9 years
September 27, 2018
February 15, 2023
October 19, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cumulative Incidence of Severe Oral Mucositis
Cumulative incidence of severe oral mucositis is defined as the proportion of subjects with any occurrence of WHO Grade 3 to 4 OM, during the Study Treatment Period. Incidence of severe OM is defined as any occurrence of WHO Grade 3 or 4 OM through the last IMRT fraction after the start of IMRT. Incidence was imputed using multiple imputation for subjects with incomplete follow-up for severe OM through 60 Gy who did not have an occurrence of severe OM before the last IMRT fraction.
From the first IMRT fraction through the end of the study treatment period (completion of study drug administration, IMRT and chemotherapy), which is estimated to be 7 weeks.
Study Arms (2)
GC4419 (avasopasem manganese) 90 mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
60 minute IV infusion
Eligibility Criteria
You may qualify if:
- squamous cell carcinoma of the head and neck
- treatment plan to receive IMRT delivered as single daily fractions of 2.0 to 2.2 Gy with a cumulative radiation dose of 60-72 Gy
- Treatment plan to receive standard cisplatin monotherapy
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Adequate hematologic, renal and liver function
- Negative serum pregnancy test
- Use of effective contraception
You may not qualify if:
- Tumor of the lips, larynx, hypopharynx, nasopharynx, sinuses, or salivary glands
- Metastatic disease
- Prior radiotherapy to the region of the study cancer or adjacent anatomical
- Prior induction chemotherapy
- Receiving any approved or investigational anti-cancer agent other than those provided for in this study
- Concurrent participation in another interventional clinical study
- Inability to eat soft solid food at baseline
- Malignant tumors other than HNC within the last 5 years
- Active infectious disease excluding oral candidiasis
- Presence of oral mucositis at baseline
- Known history of HIV or active hepatitis B/C
- Female patients who are pregnant or breastfeeding
- Known allergies or intolerance to cisplatin and similar platinum-containing compounds
- Requirement for concurrent treatment with nitrates or other drugs that may create a risk for a precipitous decrease in blood pressure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (97)
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
Fowler Family Center for Cancer
Jonesboro, Arkansas, 72401, United States
The Oncology Institute of Hope & Innovation
Corona, California, 92882, United States
Chan Soon-Shiong Institute for Medicine
Costa Mesa, California, 92627, United States
Long Beach Veteran Affairs Healthcare System
Long Beach, California, 90822, United States
USC Norris Cancer Center
Los Angeles, California, 90033, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Clinical Trials and Research Associates, Inc.
Montebello, California, 90640, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663, United States
Compassionate Cancer Care
Riverside, California, 92501, United States
Sharp Clinical Oncology Research
San Diego, California, 92123, United States
The Oncology Institute of Hope & Innovation
Whittier, California, 90603, United States
Dignity Health Research Institute
Woodland, California, 95695, United States
St. Mary's Hospital Regional Medical Center
Grand Junction, Colorado, 81501, United States
Bay Pines VA HealthCare System
Bay Pines, Florida, 33744, United States
Boca Raton Regional Hospital, Lynn Cancer Institute
Boca Raton, Florida, 33486, United States
Mayo Clinic Florida
Jacksonville, Florida, 32224, United States
Cancer Specialists of North Florida
Jacksonville, Florida, 32256, United States
Lakeland Regional Cancer Center
Lakeland, Florida, 33805, United States
BRCR Global
Plantation, Florida, 33322, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322, United States
IACT Health
Columbus, Georgia, 31904, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611, United States
SwedishAmerican Regional Cancer Center
Rockford, Illinois, 61114, United States
Parkview Research Center
Fort Wayne, Indiana, 46845, United States
Goshen Center for Cancer Care
Goshen, Indiana, 46526, United States
The University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242, United States
Appalachian Regional Healthcare, INC.
Hazard, Kentucky, 41701, United States
University of Louisville/James Graham Brown Cancer Center
Louisville, Kentucky, 40202, United States
Norton Cancer Institute
Louisville, Kentucky, 40241, United States
MetroWest Medical Center
Framingham, Massachusetts, 01702, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Minneapolis VA Healthcare System
Minneapolis, Minnesota, 55417, United States
Hattiesburg Clinic Hematology/Oncology
Hattiesburg, Mississippi, 39401, United States
Henry Ford Allegiance Health Hematology Oncology
Jackson, Mississippi, 49201, United States
Ellis Fischel Cancer Center - University of Missouri
Columbia, Missouri, 65212, United States
Delbert Day Cancer Institute, Phelps County Regional Medical Center
Rolla, Missouri, 65401, United States
Mosaic Life Care/Heartland Regional Medical Center
Saint Joseph, Missouri, 64507, United States
Cox Medical Center
Springfield, Missouri, 65807, United States
St. Vincent Frontier Cancer Center
Billings, Montana, 59102, United States
Benefis Sletten Cancer institute
Great Falls, Montana, 59405, United States
CHI Health St. Francis
Grand Island, Nebraska, 68803, United States
Renown Regional Medical Center
Reno, Nevada, 89502, United States
Exeter Hospital
Exeter, New Hampshire, 03833, United States
Hunterdon Hematology Oncology, LLC
Flemington, New Jersey, 08822, United States
Summit Medical Group
Florham Park, New Jersey, 07932, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753, United States
New York Oncology Hematology, P.C.
Albany, New York, 12206, United States
NY Cancer and Blood Specialists
East Setauket, New York, 11733, United States
New York- Presbyterian Queens/ Weill Cornell
Flushing, New York, 11355, United States
Wilmot Cancer Institute - Univeristy of Rochester
Rochester, New York, 14642, United States
School of Dental Medicine at East Carolina University
Greenville, North Carolina, 27834, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157, United States
Summa Health
Akron, Ohio, 44304, United States
University Hospitals Seidman Cancer Center
Cleveland, Ohio, 44106, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Willamette Valley Cancer Institue and Research Center
Eugene, Oregon, 97401, United States
VA Portland Health Care System
Portland, Oregon, 97239, United States
St. Luke's Hospital Cancer Center
Easton, Pennsylvania, 18045, United States
Gettysburg Cancer Center
Gettysburg, Pennsylvania, 17325, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Anmed Health Cancer Center
Anderson, South Carolina, 29621, United States
Charleston Cancer Center
Charleston, South Carolina, 29406, United States
St. Francis Cancer Center
Greenville, South Carolina, 29607, United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303, United States
Mountain States Health Alliance Research Dept
Johnson City, Tennessee, 37604, United States
Tennessee Cancer Specialists
Knoxville, Tennessee, 37909, United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920, United States
Texas Oncology - Beaumont Mamie McFaddin Ward Cancer Center
Beaumont, Texas, 77702, United States
Texas Oncology- Dallas Presbyterian Hospital
Dallas, Texas, 75231, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
Texas Oncology - Denton South
Denton, Texas, 76210, United States
Texas Oncology - El Paso Cancer Treatment Center
El Paso, Texas, 79902, United States
SAMMC
Fort Sam Houston, Texas, 78234, United States
Texas Oncology-McAllen
McAllen, Texas, 78503, United States
Texas Oncology - McKinney
McKinney, Texas, 75071, United States
Texas Oncology, Plano West
Plano, Texas, 75093, United States
Baylor Scott & White- Round Rock
Round Rock, Texas, 78665, United States
Texas Oncology - Sugar Land
Sugar Land, Texas, 77479, United States
Texas Oncology - Waco
Waco, Texas, 76712, United States
Fort Belvoir Community Hospital
Fort Belvoir, Virginia, 22060, United States
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Roanoke, Virginia, 24014, United States
Providence Regional Cancer Partnership
Everett, Washington, 98201, United States
Cancer Care Northwest
Spokane, Washington, 99216, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
BC Cancer Center - Vancouver
Vancouver, British Columbia, V574E6, Canada
CIUSS de L'Est-de-I'lle de Montreal - Hopital Maisonneuve- Rosemont
Montreal, Quebec, H1T 2M4, Canada
McGill University Health Center- Cedars Cancer Center
Montreal, Quebec, H4A 3J1, Canada
CHU de Quebec - Universite Laval
Québec, Quebec, G1R 2J6, Canada
Centre Intégré Universitaire de Santé et de Services Sociaux du Saguenay-Lac-Saint-Jean
Chicoutimi, G7H 5H6, Canada
Northeast Cancer Centre of Health Sciences North
Greater Sudbury, P3E 5J1, Canada
Juravinski Cancer Centre
Hamilton, L8V 5C2, Canada
Centre Hospitalier Universitaire de Montreal (CHUM)
Montreal, H2X OC1, Canada
Jewish General Hospital
Montreal, H3T 1E2, Canada
Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie et du Centre du Québec
Trois-Rivières, G8Z3R9, Canada
Clinical Research Puerto Rico
San Juan, 00909, Puerto Rico
Related Publications (5)
Anderson CM, Lee CM, Kelley JR, et al. ROMAN: Phase 3 trial of avasopasem manganese (GC4419) for severe oral mucositis (SOM) in patients receiving chemoradiotherapy (CRT) for locally advanced, nonmetastatic head and neck cancer (LAHNC). Journal of Clinical Oncology 2022 40:16_suppl, 6005-6005
BACKGROUNDSaunders D, Lee C, Kelley J, et al. ROMAN: Phase 3 trial of avasopasem to reduce chemoradiotherapy (CRT)-related severe oral mucositis (SOM) in patients with head and neck cancer (HNC). Support Care Cancer 30 (Suppl 1), 1-207 (2022).
BACKGROUNDAnderson C, Lee CM, Kelley JR, Walker GV, Dunlap NE, Bar-Ad VC, Miller DA, King VJ, Peddada AV, Ciuba DF, Vincent F, Muzyka BC, Gillespie-Twardy AL, Sonis ST, Holmlund J, Beardsley RA, Kennedy EP, Saunders D. Avasopasem manganese treatment for severe oral mucositis from chemoradiotherapy for locally advanced head and neck cancer: phase 3 randomized controlled trial (ROMAN). EClinicalMedicine. 2025 Oct 8;89:103539. doi: 10.1016/j.eclinm.2025.103539. eCollection 2025 Nov.
PMID: 41127563DERIVEDSquillace S, Salvemini D. Nitroxidative stress in pain and opioid-induced adverse effects: therapeutic opportunities. Pain. 2022 Feb 1;163(2):205-213. doi: 10.1097/j.pain.0000000000002347. No abstract available.
PMID: 34145168DERIVEDAnderson CM, Lee CM, Saunders DP, Curtis A, Dunlap N, Nangia C, Lee AS, Gordon SM, Kovoor P, Arevalo-Araujo R, Bar-Ad V, Peddada A, Colvett K, Miller D, Jain AK, Wheeler J, Blakaj D, Bonomi M, Agarwala SS, Garg M, Worden F, Holmlund J, Brill JM, Downs M, Sonis ST, Katz S, Buatti JM. Phase IIb, Randomized, Double-Blind Trial of GC4419 Versus Placebo to Reduce Severe Oral Mucositis Due to Concurrent Radiotherapy and Cisplatin For Head and Neck Cancer. J Clin Oncol. 2019 Dec 1;37(34):3256-3265. doi: 10.1200/JCO.19.01507. Epub 2019 Oct 16.
PMID: 31618127DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Megan Holm
- Organization
- Galera Therapeutics
Study Officials
- STUDY CHAIR
Gene Kennedy, MD
Galera Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2018
First Posted
September 28, 2018
Study Start
October 3, 2018
Primary Completion
August 13, 2021
Study Completion
August 25, 2023
Last Updated
October 24, 2023
Results First Posted
April 13, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share