Oral Mucositis Clinical Trial
Official title:
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
| Verified date | October 2023 |
| Source | Galera Therapeutics, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 455 |
| Est. completion date | August 25, 2023 |
| Est. primary completion date | August 13, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Centre Intégré Universitaire de Santé et de Services Sociaux du Saguenay-Lac-Saint-Jean | Chicoutimi | |
| Canada | Juravinski Cancer Centre | Hamilton | |
| Canada | Centre Hospitalier Universitaire de Montreal (CHUM) | Montréal | |
| Canada | CIUSS de L'Est-de-I'lle de Montreal - Hopital Maisonneuve- Rosemont | Montréal | Quebec |
| Canada | Jewish General Hospital | Montréal | |
| Canada | McGill University Health Center- Cedars Cancer Center | Montréal | Quebec |
| Canada | CHU de Quebec - Universite Laval | Québec | Quebec |
| Canada | Northeast Cancer Centre of Health Sciences North | Sudbury | |
| Canada | Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie et du Centre du Québec | Trois-Rivières | |
| Canada | BC Cancer Center - Vancouver | Vancouver | British Columbia |
| Puerto Rico | Clinical Research Puerto Rico | San Juan | |
| United States | Summa Health | Akron | Ohio |
| United States | New York Oncology Hematology, P.C. | Albany | New York |
| United States | Anmed Health Cancer Center | Anderson | South Carolina |
| United States | University of Michigan | Ann Arbor | Michigan |
| United States | Winship Cancer Institute of Emory University | Atlanta | Georgia |
| United States | Bay Pines VA HealthCare System | Bay Pines | Florida |
| United States | Texas Oncology - Beaumont Mamie McFaddin Ward Cancer Center | Beaumont | Texas |
| United States | St. Vincent Frontier Cancer Center | Billings | Montana |
| United States | Boca Raton Regional Hospital, Lynn Cancer Institute | Boca Raton | Florida |
| United States | Charleston Cancer Center | Charleston | South Carolina |
| United States | Northwestern University Feinberg School of Medicine | Chicago | Illinois |
| United States | University Hospitals Seidman Cancer Center | Cleveland | Ohio |
| United States | Ellis Fischel Cancer Center - University of Missouri | Columbia | Missouri |
| United States | IACT Health | Columbus | Georgia |
| United States | The Ohio State University | Columbus | Ohio |
| United States | The Oncology Institute of Hope & Innovation | Corona | California |
| United States | Chan Soon-Shiong Institute for Medicine | Costa Mesa | California |
| United States | Texas Oncology- Dallas Presbyterian Hospital | Dallas | Texas |
| United States | Texas Oncology-Baylor Charles A. Sammons Cancer Center | Dallas | Texas |
| United States | Texas Oncology - Denton South | Denton | Texas |
| United States | NY Cancer and Blood Specialists | East Setauket | New York |
| United States | St. Luke's Hospital Cancer Center | Easton | Pennsylvania |
| United States | Texas Oncology - El Paso Cancer Treatment Center | El Paso | Texas |
| United States | Willamette Valley Cancer Institue and Research Center | Eugene | Oregon |
| United States | Providence Regional Cancer Partnership | Everett | Washington |
| United States | Exeter Hospital | Exeter | New Hampshire |
| United States | Hunterdon Hematology Oncology, LLC | Flemington | New Jersey |
| United States | Summit Medical Group | Florham Park | New Jersey |
| United States | New York- Presbyterian Queens/ Weill Cornell | Flushing | New York |
| United States | Fort Belvoir Community Hospital | Fort Belvoir | Virginia |
| United States | SAMMC | Fort Sam Houston | Texas |
| United States | Parkview Research Center | Fort Wayne | Indiana |
| United States | MetroWest Medical Center | Framingham | Massachusetts |
| United States | Gettysburg Cancer Center | Gettysburg | Pennsylvania |
| United States | Banner MD Anderson Cancer Center | Gilbert | Arizona |
| United States | Goshen Center for Cancer Care | Goshen | Indiana |
| United States | CHI Health St. Francis | Grand Island | Nebraska |
| United States | St. Mary's Hospital Regional Medical Center | Grand Junction | Colorado |
| United States | Benefis Sletten Cancer institute | Great Falls | Montana |
| United States | School of Dental Medicine at East Carolina University | Greenville | North Carolina |
| United States | St. Francis Cancer Center | Greenville | South Carolina |
| United States | Hattiesburg Clinic Hematology/Oncology | Hattiesburg | Mississippi |
| United States | Appalachian Regional Healthcare, INC. | Hazard | Kentucky |
| United States | The University of Iowa Hospitals & Clinics | Iowa City | Iowa |
| United States | Henry Ford Allegiance Health Hematology Oncology | Jackson | Mississippi |
| United States | Cancer Specialists of North Florida | Jacksonville | Florida |
| United States | Mayo Clinic Florida | Jacksonville | Florida |
| United States | Mountain States Health Alliance Research Dept | Johnson City | Tennessee |
| United States | Fowler Family Center for Cancer | Jonesboro | Arkansas |
| United States | Tennessee Cancer Specialists | Knoxville | Tennessee |
| United States | University of Tennessee Medical Center | Knoxville | Tennessee |
| United States | Lakeland Regional Cancer Center | Lakeland | Florida |
| United States | Long Beach Veteran Affairs Healthcare System | Long Beach | California |
| United States | Cedars-Sinai Medical Center | Los Angeles | California |
| United States | USC Norris Cancer Center | Los Angeles | California |
| United States | Norton Cancer Institute | Louisville | Kentucky |
| United States | University of Louisville/James Graham Brown Cancer Center | Louisville | Kentucky |
| United States | Texas Oncology-McAllen | McAllen | Texas |
| United States | Texas Oncology - McKinney | McKinney | Texas |
| United States | Minneapolis VA Healthcare System | Minneapolis | Minnesota |
| United States | Clinical Trials and Research Associates, Inc. | Montebello | California |
| United States | West Virginia University | Morgantown | West Virginia |
| United States | Jersey Shore University Medical Center | Neptune | New Jersey |
| United States | Hoag Memorial Hospital Presbyterian | Newport Beach | California |
| United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
| United States | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
| United States | Texas Oncology, Plano West | Plano | Texas |
| United States | BRCR Global | Plantation | Florida |
| United States | VA Portland Health Care System | Portland | Oregon |
| United States | Renown Regional Medical Center | Reno | Nevada |
| United States | Compassionate Cancer Care | Riverside | California |
| United States | Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care | Roanoke | Virginia |
| United States | Wilmot Cancer Institute - Univeristy of Rochester | Rochester | New York |
| United States | SwedishAmerican Regional Cancer Center | Rockford | Illinois |
| United States | Delbert Day Cancer Institute, Phelps County Regional Medical Center | Rolla | Missouri |
| United States | Baylor Scott & White- Round Rock | Round Rock | Texas |
| United States | Mosaic Life Care/Heartland Regional Medical Center | Saint Joseph | Missouri |
| United States | Sharp Clinical Oncology Research | San Diego | California |
| United States | Spartanburg Medical Center | Spartanburg | South Carolina |
| United States | Cancer Care Northwest | Spokane | Washington |
| United States | Cox Medical Center | Springfield | Missouri |
| United States | Texas Oncology - Sugar Land | Sugar Land | Texas |
| United States | Texas Oncology - Waco | Waco | Texas |
| United States | The Oncology Institute of Hope & Innovation | Whittier | California |
| United States | Wake Forest Baptist Health | Winston-Salem | North Carolina |
| United States | Dignity Health Research Institute | Woodland | California |
| Lead Sponsor | Collaborator |
|---|---|
| Galera Therapeutics, Inc. |
United States, Canada, Puerto Rico,
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
Saunders 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).
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. |
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