Phase 3
Completed N=455
ROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer Patients
Source: ClinicalTrials.gov NCT03689712 ↗Enrolled (actual)
455
Serious AEs
32.7%
Results posted
Apr 2023
Primary outcomePrimary: Cumulative Incidence of Severe Oral Mucositis — 53.8; 64.0 percentage of patients
◆ Published Evidence
Highly cited
124citations · ~18 / year
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.
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.
Linked Publications (3)
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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.
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Nitroxidative stress in pain and opioid-induced adverse effects: therapeutic opportunities.
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Avasopasem manganese treatment for severe oral mucositis from chemoradiotherapy for locally advanced head and neck cancer: phase 3 randomized controlled trial (ROMAN).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Incidence of Severe Oral Mucositis |
53.8; 64.0 | — |
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
Data sourced from ClinicalTrials.gov (NCT03689712) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.