Back to resultsROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer Patients
Primary Purpose
Oral Mucositis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
GC4419 90mg
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Oral Mucositis focused on measuring Oral Mucositis, Superoxide Dismutase Mimetic, Cisplatin, Intensity-Modulated Radiation Therapy, Chemoradiation, OM, IMRT, Head and Neck Cancer, Squamous Cell Carcinoma, SCC, Oral Cavity, Oropharnyx, Mouth Sores, avasopasem mangenese
Eligibility Criteria
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
Sites / Locations
- Banner MD Anderson Cancer Center
- Fowler Family Center for Cancer
- The Oncology Institute of Hope & Innovation
- Chan Soon-Shiong Institute for Medicine
- Long Beach Veteran Affairs Healthcare System
- USC Norris Cancer Center
- Cedars-Sinai Medical Center
- Clinical Trials and Research Associates, Inc.
- Hoag Memorial Hospital Presbyterian
- Compassionate Cancer Care
- Sharp Clinical Oncology Research
- The Oncology Institute of Hope & Innovation
- Dignity Health Research Institute
- St. Mary's Hospital Regional Medical Center
- Bay Pines VA HealthCare System
- Boca Raton Regional Hospital, Lynn Cancer Institute
- Mayo Clinic Florida
- Cancer Specialists of North Florida
- Lakeland Regional Cancer Center
- BRCR Global
- Winship Cancer Institute of Emory University
- IACT Health
- Northwestern University Feinberg School of Medicine
- SwedishAmerican Regional Cancer Center
- Parkview Research Center
- Goshen Center for Cancer Care
- The University of Iowa Hospitals & Clinics
- Appalachian Regional Healthcare, INC.
- University of Louisville/James Graham Brown Cancer Center
- Norton Cancer Institute
- MetroWest Medical Center
- University of Michigan
- Minneapolis VA Healthcare System
- Hattiesburg Clinic Hematology/Oncology
- Henry Ford Allegiance Health Hematology Oncology
- Ellis Fischel Cancer Center - University of Missouri
- Delbert Day Cancer Institute, Phelps County Regional Medical Center
- Mosaic Life Care/Heartland Regional Medical Center
- Cox Medical Center
- St. Vincent Frontier Cancer Center
- Benefis Sletten Cancer institute
- CHI Health St. Francis
- Renown Regional Medical Center
- Exeter Hospital
- Hunterdon Hematology Oncology, LLC
- Summit Medical Group
- Jersey Shore University Medical Center
- New York Oncology Hematology, P.C.
- NY Cancer and Blood Specialists
- New York- Presbyterian Queens/ Weill Cornell
- Wilmot Cancer Institute - Univeristy of Rochester
- School of Dental Medicine at East Carolina University
- Wake Forest Baptist Health
- Summa Health
- University Hospitals Seidman Cancer Center
- The Ohio State University
- Willamette Valley Cancer Institue and Research Center
- VA Portland Health Care System
- St. Luke's Hospital Cancer Center
- Gettysburg Cancer Center
- Thomas Jefferson University Hospital
- Fox Chase Cancer Center
- Anmed Health Cancer Center
- Charleston Cancer Center
- St. Francis Cancer Center
- Spartanburg Medical Center
- Mountain States Health Alliance Research Dept
- Tennessee Cancer Specialists
- University of Tennessee Medical Center
- Texas Oncology - Beaumont Mamie McFaddin Ward Cancer Center
- Texas Oncology- Dallas Presbyterian Hospital
- Texas Oncology-Baylor Charles A. Sammons Cancer Center
- Texas Oncology - Denton South
- Texas Oncology - El Paso Cancer Treatment Center
- SAMMC
- Texas Oncology-McAllen
- Texas Oncology - McKinney
- Texas Oncology, Plano West
- Baylor Scott & White- Round Rock
- Texas Oncology - Sugar Land
- Texas Oncology - Waco
- Fort Belvoir Community Hospital
- Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
- Providence Regional Cancer Partnership
- Cancer Care Northwest
- West Virginia University
- BC Cancer Center - Vancouver
- CIUSS de L'Est-de-I'lle de Montreal - Hopital Maisonneuve- Rosemont
- McGill University Health Center- Cedars Cancer Center
- CHU de Quebec - Universite Laval
- Centre Intégré Universitaire de Santé et de Services Sociaux du Saguenay-Lac-Saint-Jean
- Juravinski Cancer Centre
- Centre Hospitalier Universitaire de Montreal (CHUM)
- Jewish General Hospital
- Northeast Cancer Centre of Health Sciences North
- Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie et du Centre du Québec
- Clinical Research Puerto Rico
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
GC4419 (avasopasem manganese) 90 mg
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03689712
First Posted
September 27, 2018
Last Updated
October 19, 2023
Sponsor
Galera Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03689712
Brief Title
ROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
October 3, 2018 (Actual)
Primary Completion Date
August 13, 2021 (Actual)
Study Completion Date
August 25, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galera Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Mucositis
Keywords
Oral Mucositis, Superoxide Dismutase Mimetic, Cisplatin, Intensity-Modulated Radiation Therapy, Chemoradiation, OM, IMRT, Head and Neck Cancer, Squamous Cell Carcinoma, SCC, Oral Cavity, Oropharnyx, Mouth Sores, avasopasem mangenese
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
455 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GC4419 (avasopasem manganese) 90 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
GC4419 90mg
Other Intervention Name(s)
avasopasem manganese
Intervention Description
60 minute IV infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
60 minute IV infusion
Primary Outcome Measure Information:
Title
Cumulative Incidence of Severe Oral Mucositis
Description
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.
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gene Kennedy, MD
Organizational Affiliation
Galera Therapeutics
Official's Role
Study Chair
Facility Information:
Facility Name
Banner MD Anderson Cancer Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
Fowler Family Center for Cancer
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
The Oncology Institute of Hope & Innovation
City
Corona
State/Province
California
ZIP/Postal Code
92882
Country
United States
Facility Name
Chan Soon-Shiong Institute for Medicine
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92627
Country
United States
Facility Name
Long Beach Veteran Affairs Healthcare System
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
USC Norris Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Clinical Trials and Research Associates, Inc.
City
Montebello
State/Province
California
ZIP/Postal Code
90640
Country
United States
Facility Name
Hoag Memorial Hospital Presbyterian
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Compassionate Cancer Care
City
Riverside
State/Province
California
ZIP/Postal Code
92501
Country
United States
Facility Name
Sharp Clinical Oncology Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
The Oncology Institute of Hope & Innovation
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
Dignity Health Research Institute
City
Woodland
State/Province
California
ZIP/Postal Code
95695
Country
United States
Facility Name
St. Mary's Hospital Regional Medical Center
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81501
Country
United States
Facility Name
Bay Pines VA HealthCare System
City
Bay Pines
State/Province
Florida
ZIP/Postal Code
33744
Country
United States
Facility Name
Boca Raton Regional Hospital, Lynn Cancer Institute
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Cancer Specialists of North Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Lakeland Regional Cancer Center
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
BRCR Global
City
Plantation
State/Province
Florida
ZIP/Postal Code
33322
Country
United States
Facility Name
Winship Cancer Institute of Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
IACT Health
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
SwedishAmerican Regional Cancer Center
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61114
Country
United States
Facility Name
Parkview Research Center
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
Goshen Center for Cancer Care
City
Goshen
State/Province
Indiana
ZIP/Postal Code
46526
Country
United States
Facility Name
The University of Iowa Hospitals & Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Appalachian Regional Healthcare, INC.
City
Hazard
State/Province
Kentucky
ZIP/Postal Code
41701
Country
United States
Facility Name
University of Louisville/James Graham Brown Cancer Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
MetroWest Medical Center
City
Framingham
State/Province
Massachusetts
ZIP/Postal Code
01702
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Minneapolis VA Healthcare System
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
Hattiesburg Clinic Hematology/Oncology
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Facility Name
Henry Ford Allegiance Health Hematology Oncology
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
49201
Country
United States
Facility Name
Ellis Fischel Cancer Center - University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Delbert Day Cancer Institute, Phelps County Regional Medical Center
City
Rolla
State/Province
Missouri
ZIP/Postal Code
65401
Country
United States
Facility Name
Mosaic Life Care/Heartland Regional Medical Center
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64507
Country
United States
Facility Name
Cox Medical Center
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
St. Vincent Frontier Cancer Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Benefis Sletten Cancer institute
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
CHI Health St. Francis
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68803
Country
United States
Facility Name
Renown Regional Medical Center
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Exeter Hospital
City
Exeter
State/Province
New Hampshire
ZIP/Postal Code
03833
Country
United States
Facility Name
Hunterdon Hematology Oncology, LLC
City
Flemington
State/Province
New Jersey
ZIP/Postal Code
08822
Country
United States
Facility Name
Summit Medical Group
City
Florham Park
State/Province
New Jersey
ZIP/Postal Code
07932
Country
United States
Facility Name
Jersey Shore University Medical Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Facility Name
New York Oncology Hematology, P.C.
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
NY Cancer and Blood Specialists
City
East Setauket
State/Province
New York
ZIP/Postal Code
11733
Country
United States
Facility Name
New York- Presbyterian Queens/ Weill Cornell
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
Facility Name
Wilmot Cancer Institute - Univeristy of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
School of Dental Medicine at East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Summa Health
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Facility Name
University Hospitals Seidman Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Willamette Valley Cancer Institue and Research Center
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
VA Portland Health Care System
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
St. Luke's Hospital Cancer Center
City
Easton
State/Province
Pennsylvania
ZIP/Postal Code
18045
Country
United States
Facility Name
Gettysburg Cancer Center
City
Gettysburg
State/Province
Pennsylvania
ZIP/Postal Code
17325
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Anmed Health Cancer Center
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Charleston Cancer Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
St. Francis Cancer Center
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Spartanburg Medical Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Mountain States Health Alliance Research Dept
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604
Country
United States
Facility Name
Tennessee Cancer Specialists
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
University of Tennessee Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Texas Oncology - Beaumont Mamie McFaddin Ward Cancer Center
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77702
Country
United States
Facility Name
Texas Oncology- Dallas Presbyterian Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Texas Oncology-Baylor Charles A. Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Texas Oncology - Denton South
City
Denton
State/Province
Texas
ZIP/Postal Code
76210
Country
United States
Facility Name
Texas Oncology - El Paso Cancer Treatment Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
SAMMC
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
Texas Oncology-McAllen
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Texas Oncology - McKinney
City
McKinney
State/Province
Texas
ZIP/Postal Code
75071
Country
United States
Facility Name
Texas Oncology, Plano West
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Baylor Scott & White- Round Rock
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78665
Country
United States
Facility Name
Texas Oncology - Sugar Land
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Texas Oncology - Waco
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Facility Name
Fort Belvoir Community Hospital
City
Fort Belvoir
State/Province
Virginia
ZIP/Postal Code
22060
Country
United States
Facility Name
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Providence Regional Cancer Partnership
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
Cancer Care Northwest
City
Spokane
State/Province
Washington
ZIP/Postal Code
99216
Country
United States
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
BC Cancer Center - Vancouver
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V574E6
Country
Canada
Facility Name
CIUSS de L'Est-de-I'lle de Montreal - Hopital Maisonneuve- Rosemont
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
McGill University Health Center- Cedars Cancer Center
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
CHU de Quebec - Universite Laval
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Centre Intégré Universitaire de Santé et de Services Sociaux du Saguenay-Lac-Saint-Jean
City
Chicoutimi
ZIP/Postal Code
G7H 5H6
Country
Canada
Facility Name
Juravinski Cancer Centre
City
Hamilton
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Montreal (CHUM)
City
Montréal
ZIP/Postal Code
H2X OC1
Country
Canada
Facility Name
Jewish General Hospital
City
Montréal
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Northeast Cancer Centre of Health Sciences North
City
Sudbury
ZIP/Postal Code
P3E 5J1
Country
Canada
Facility Name
Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie et du Centre du Québec
City
Trois-Rivières
ZIP/Postal Code
G8Z3R9
Country
Canada
Facility Name
Clinical Research Puerto Rico
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
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
Results Reference
background
Citation
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).
Results Reference
background
PubMed Identifier
34145168
Citation
Squillace 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.
Results Reference
derived
PubMed Identifier
31618127
Citation
Anderson 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. Erratum In: J Clin Oncol. 2020 Jan 20;38(3):288.
Results Reference
derived
Learn more about this trial
ROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer Patients
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