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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 455
- 试验地点
- 96
- 主要终点
- Cumulative Incidence of Severe Oral Mucositis
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
GC4419 (avasopasem manganese) 90 mg
干预措施: GC4419 90mg (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Cumulative Incidence of Severe Oral Mucositis
时间窗: 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.
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.
次要结局
未报告次要终点