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Oral MucositisPhase 3NCT03689712

ROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer Patients

A Phase 3 study testing GC4419 90mg in people with Oral Mucositis, run by Galera Therapeutics, Inc. at 97 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Oral Mucositis
What is being tested?
GC4419 90mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
455 participants
Where
97 sitesin 3 countries
Study dates
3 Oct 2018to 25 Aug 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

97 sites in 3 countries.

97 sites in 3 countries

United States86 sites

  • Summa Health

    Akron, Ohio, 44304

  • New York Oncology Hematology, P.C.

    Albany, New York, 12206

  • Anmed Health Cancer Center

    Anderson, South Carolina, 29621

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

  • Bay Pines VA HealthCare System

    Bay Pines, Florida, 33744

  • Texas Oncology - Beaumont Mamie McFaddin Ward Cancer Center

    Beaumont, Texas, 77702

  • St. Vincent Frontier Cancer Center

    Billings, Montana, 59102

  • Boca Raton Regional Hospital, Lynn Cancer Institute

    Boca Raton, Florida, 33486

  • Charleston Cancer Center

    Charleston, South Carolina, 29406

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611

  • University Hospitals Seidman Cancer Center

    Cleveland, Ohio, 44106

  • Ellis Fischel Cancer Center - University of Missouri

    Columbia, Missouri, 65212

  • IACT Health

    Columbus, Georgia, 31904

  • The Ohio State University

    Columbus, Ohio, 43210

  • The Oncology Institute of Hope & Innovation

    Corona, California, 92882

  • Chan Soon-Shiong Institute for Medicine

    Costa Mesa, California, 92627

  • Texas Oncology- Dallas Presbyterian Hospital

    Dallas, Texas, 75231

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • Texas Oncology - Denton South

    Denton, Texas, 76210

  • NY Cancer and Blood Specialists

    East Setauket, New York, 11733

  • St. Luke's Hospital Cancer Center

    Easton, Pennsylvania, 18045

  • Texas Oncology - El Paso Cancer Treatment Center

    El Paso, Texas, 79902

  • Willamette Valley Cancer Institue and Research Center

    Eugene, Oregon, 97401

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

  • Exeter Hospital

    Exeter, New Hampshire, 03833

  • Hunterdon Hematology Oncology, LLC

    Flemington, New Jersey, 08822

  • Summit Medical Group

    Florham Park, New Jersey, 07932

  • New York- Presbyterian Queens/ Weill Cornell

    Flushing, New York, 11355

  • Fort Belvoir Community Hospital

    Fort Belvoir, Virginia, 22060

  • SAMMC

    Fort Sam Houston, Texas, 78234

  • Parkview Research Center

    Fort Wayne, Indiana, 46845

  • MetroWest Medical Center

    Framingham, Massachusetts, 01702

  • Gettysburg Cancer Center

    Gettysburg, Pennsylvania, 17325

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • Goshen Center for Cancer Care

    Goshen, Indiana, 46526

  • CHI Health St. Francis

    Grand Island, Nebraska, 68803

  • St. Mary's Hospital Regional Medical Center

    Grand Junction, Colorado, 81501

  • Benefis Sletten Cancer institute

    Great Falls, Montana, 59405

  • School of Dental Medicine at East Carolina University

    Greenville, North Carolina, 27834

  • St. Francis Cancer Center

    Greenville, South Carolina, 29607

  • Hattiesburg Clinic Hematology/Oncology

    Hattiesburg, Mississippi, 39401

  • Appalachian Regional Healthcare, INC.

    Hazard, Kentucky, 41701

  • The University of Iowa Hospitals & Clinics

    Iowa City, Iowa, 52242

  • Henry Ford Allegiance Health Hematology Oncology

    Jackson, Mississippi, 49201

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224

  • Cancer Specialists of North Florida

    Jacksonville, Florida, 32256

  • Mountain States Health Alliance Research Dept

    Johnson City, Tennessee, 37604

  • Fowler Family Center for Cancer

    Jonesboro, Arkansas, 72401

  • Tennessee Cancer Specialists

    Knoxville, Tennessee, 37909

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • Lakeland Regional Cancer Center

    Lakeland, Florida, 33805

  • Long Beach Veteran Affairs Healthcare System

    Long Beach, California, 90822

  • USC Norris Cancer Center

    Los Angeles, California, 90033

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • University of Louisville/James Graham Brown Cancer Center

    Louisville, Kentucky, 40202

  • Norton Cancer Institute

    Louisville, Kentucky, 40241

  • Texas Oncology-McAllen

    McAllen, Texas, 78503

  • Texas Oncology - McKinney

    McKinney, Texas, 75071

  • Minneapolis VA Healthcare System

    Minneapolis, Minnesota, 55417

  • Clinical Trials and Research Associates, Inc.

    Montebello, California, 90640

  • West Virginia University

    Morgantown, West Virginia, 26506

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Texas Oncology, Plano West

    Plano, Texas, 75093

  • BRCR Global

    Plantation, Florida, 33322

  • VA Portland Health Care System

    Portland, Oregon, 97239

  • Renown Regional Medical Center

    Reno, Nevada, 89502

  • Compassionate Cancer Care

    Riverside, California, 92501

  • Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

    Roanoke, Virginia, 24014

  • Wilmot Cancer Institute - Univeristy of Rochester

    Rochester, New York, 14642

  • SwedishAmerican Regional Cancer Center

    Rockford, Illinois, 61114

  • Delbert Day Cancer Institute, Phelps County Regional Medical Center

    Rolla, Missouri, 65401

  • Baylor Scott & White- Round Rock

    Round Rock, Texas, 78665

  • Mosaic Life Care/Heartland Regional Medical Center

    Saint Joseph, Missouri, 64507

  • Sharp Clinical Oncology Research

    San Diego, California, 92123

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303

  • Cancer Care Northwest

    Spokane, Washington, 99216

  • Cox Medical Center

    Springfield, Missouri, 65807

  • Texas Oncology - Sugar Land

    Sugar Land, Texas, 77479

  • Texas Oncology - Waco

    Waco, Texas, 76712

  • The Oncology Institute of Hope & Innovation

    Whittier, California, 90603

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157

  • Dignity Health Research Institute

    Woodland, California, 95695

Other trials in United States

Canada10 sites

  • Centre Intégré Universitaire de Santé et de Services Sociaux du Saguenay-Lac-Saint-Jean

    Chicoutimi, G7H 5H6

  • Northeast Cancer Centre of Health Sciences North

    Greater Sudbury, P3E 5J1

  • Juravinski Cancer Centre

    Hamilton, L8V 5C2

  • CIUSS de L'Est-de-I'lle de Montreal - Hopital Maisonneuve- Rosemont

    Montreal, Quebec, H1T 2M4

  • McGill University Health Center- Cedars Cancer Center

    Montreal, Quebec, H4A 3J1

  • Centre Hospitalier Universitaire de Montreal (CHUM)

    Montreal, H2X OC1

  • Jewish General Hospital

    Montreal, H3T 1E2

  • CHU de Quebec - Universite Laval

    Québec, Quebec, G1R 2J6

  • Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie et du Centre du Québec

    Trois-Rivières, G8Z3R9

  • BC Cancer Center - Vancouver

    Vancouver, British Columbia, V574E6

Other trials in Canada

Puerto Rico1 site

  • Clinical Research Puerto Rico

    San Juan, 00909

Other trials in Puerto Rico

About this study

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

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.

Conditions
Oral Mucositis
Being tested
GC4419 90mg, Placebo
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
Medical subject headings
Stomatitis, Head and Neck Neoplasms, Carcinoma, Squamous Cell, Oral Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GC4419 90mgDrug

    Also called avasopasem manganese

    60 minute IV infusion

  • PlaceboDrug

    60 minute IV infusion

Study groups in NCT03689712
Study groupRoleWhat they receive
GC4419 (avasopasem manganese) 90 mgExperimentalNot described
Receives: Drug: GC4419 90mg
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2018
  2. Study start3 Oct 2018
  3. Primary completion13 Aug 2021
  4. Study completion25 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
455 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03689712
Sponsor's protocol ID
GTI-4419-301
Status last verified
Oct 2023
First submitted
27 Sep 2018
Last updated
24 Oct 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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).

  • Anderson 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.

    PubMed 41127563

  • 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.

    PubMed 34145168

  • 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.

    PubMed 31618127

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GC4419 90mg in people with Oral Mucositis, run by Galera Therapeutics, Inc. at 97 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 97 sites in United States, Canada, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative Incidence of Severe Oral Mucositis (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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03689712, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2023.

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