Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2019
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.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03689712 (ROMAN), which is not on this map. Cited by 61 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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
Who cites it
61 citing papers in PubMed, 4 syntheses or guidelines pooled it, 124 citations in OpenAlex.
- Cetuximab increases the risk of oral mucositis in radiotherapy-treated head and neck cancer compared to cisplatin: a systematic review of randomized controlled clinical trials.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025Pooled it
- Manganese-derived biomaterials for tumor diagnosis and therapy.Journal of nanobiotechnology · 2024Pooled it
- A systematic literature review of the human papillomavirus prevalence in locally and regionally advanced and recurrent/metastatic head and neck cancers through the last decade: The "ALARM" study.Cancer medicine · 2024Pooled it
- Efficacy of Oral Cryotherapy in the Prevention of Oral Mucositis Associated with Cancer Chemotherapy: Systematic Review with Meta-Analysis and Trial Sequential Analysis.Current oncology (Toronto, Ont.) · 2021Pooled it
- Streptococcus salivarius K12 Alleviates Oral Mucositis in Patients Undergoing Radiotherapy for Malignant Head and Neck Tumors: A Randomized Controlled Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024Trial
- The antioxidant and anti-inflammatory activities of avasopasem manganese in age-associated, cisplatin-induced renal injury.Redox biology · 2024Trial
- Stereotactic body radiotherapy with or without selective dismutase mimetic in pancreatic adenocarcinoma: an adaptive, randomised, double-blind, placebo-controlled, phase 1b/2 trial.The Lancet. Oncology · 2023Trial
- Randomized placebo-controlled phase II trial of high-dose melatonin mucoadhesive oral gel for the prevention and treatment of oral mucositis in patients with head and neck cancer undergoing radiation therapy concurrent with systemic treatment.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2021Trial
- Breaking through the radiation dilemma: development and clinical translation of anti-radiation drugs.Pharmaceutical science advances · 2026Review
- Radiomitigators: Breakthroughs in Post-Radiation Recovery.Antioxidants (Basel, Switzerland) · 2026Review
- Effectiveness ofFrontiers in immunology · 2026Article
- Avasopasem manganese acts as both a radioprotector and a radiomitigator of radiation-induced acute or late effects.Frontiers in oncology · 2026Article
- Efficacy and Safety of Retention Enema with Traditional Chinese Medicine for Chronic Radiation-Induced Rectal Injury: Study Protocol for a Multicenter Randomized Controlled Trial.Complementary medicine research · 2026Article
- Avasopasem manganese treatment for severe oral mucositis from chemoradiotherapy for locally advanced head and neck cancer: phase 3 randomized controlled trial (ROMAN).EClinicalMedicine · 2025Article
- Targeted prevention of radiation-induced oral mucositis by glutathione-modified liposome coated K12 probiotics and clinical study.Materials today. Bio · 2025Article
- Avasopasem Manganese Shows Potential to Reduce High-Risk Carotid Plaque in Patients With Head and Neck Cancer Undergoing Chemoradiation Therapy: A Post Hoc Analysis of 2 Randomized Trials.Journal of the American Heart Association · 2025Article
- Radioprotection of healthy tissue via nanoparticle-delivered mRNA encoding for a damage-suppressor protein found in tardigrades.Nature biomedical engineering · 2025Article
- Oxidative stress responses inmBio · 2025Review
- Article
- Unraveling the complexity of radiotherapy- and chemotherapy-induced oral mucositis: insights into pathogenesis and intervention strategies.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025Review
1 more citing papers are in PubMed but not listed here.
Corrections and comments
- Commented on by
- Erratum issuedErratum.2020
Authors and funding
27 authors at 20 institutions in 2 countries.
Funding
Abstract
purposeOral mucositis (OM) remains a common, debilitating toxicity of radiation therapy (RT) for head and neck cancer. The goal of this phase IIb, multi-institutional, randomized, double-blind trial was to compare the efficacy and safety of GC4419, a superoxide dismutase mimetic, with placebo to reduce the duration, incidence, and severity of severe OM (SOM). PATIENTS AND
methodsA total of 223 patients (from 44 institutions) with locally advanced oral cavity or oropharynx cancer planned to be treated with definitive or postoperative intensity-modulated RT (IMRT; 60 to 72 Gy [≥ 50 Gy to two or more oral sites]) plus cisplatin (weekly or every 3 weeks) were randomly assigned to receive 30 mg (n = 73) or 90 mg (n = 76) of GC4419 or to receive placebo (n = 74) by 60-minute intravenous administration before each IMRT fraction. WHO grade of OM was assessed biweekly during IMRT and then weekly for up to 8 weeks after IMRT. The primary endpoint was duration of SOM tested for each active dose level versus placebo (intent-to-treat population, two-sided α of .05). The National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03, was used for adverse event grading.
resultsBaseline patient and tumor characteristics as well as treatment delivery were balanced. With 90 mg GC4419 versus placebo, SOM duration was significantly reduced (
conclusionGC4419 at a dose of 90 mg produced a significant, clinically meaningful reduction of SOM duration, incidence, and severity with acceptable safety. A phase III trial (ROMAN; ClinicalTrials.gov identifier: NCT03689712) has begun.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.