Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase II Trial of Selenomethionine as a Modulator of Efficacy and Toxicity of Chemoradiation in Locally-Advanced Squamous Cell Carcinoma of the Head and Neck
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Incidence of >= Grade 3 Mucositis
研究概览
简要总结
This randomized phase II trial is studying how well selenomethionine (SLM) works in reducing mucositis in patients with locally advanced head and neck cancer who are receiving cisplatin and radiation therapy. SLM may help prevent or reduce mucositis, or mouth sores, in patients receiving chemotherapy and radiation therapy. It is not yet known whether SLM is more effective than a placebo in reducing mucositis
详细描述
PRIMARY OBJECTIVES:
I. To assess whether SLM reduces the incidence of grade 3 or 4 mucositis in head and neck squamous cell carcinoma (HNSCC) patients treated with concurrent chemoradiation (CRT) over 7 weeks.
SECONDARY OBJECTIVES:
I. To assess the impact of SLM on tumor complete response rate, relapse-free survival, overall survival and quality of life.
II. To assess whether SLM reduces the incidence and severity of treatment-related toxicities including xerostomia, renal impairment and myelosuppression.
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
- Double
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
- •Biopsy-proven locally-advanced HNSCC, including those with cancers of the oral cavity, oropharynx, hypopharynx, larynx, nasopharynx or paranasal sinuses
- •Stage III, IVa or IVb disease
- •No prior definitive surgery for present diagnosis
- •Appropriate candidate for concurrent cisplatin and radiation as definitive treatment; patients who receive induction chemotherapy as part of a definitive treatment program that will include concurrent CRT are eligible for this study
- •Hemoglobin >= 10 g/dL (100 g/l)
- •Absolute neutrophil count >= 2,000 cells/mm^3 (2 x 10^9/l)
- •Platelets >= 100,000 cells/mm^3 (100 x 10^9/l)
- •Serum creatinine =< 1.5 mg/dL (133 umol/l) or calculated creatinine clearance >= 50 ml/min using the Cockcroft-Gault formula
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Able to give written informed consent
- •Be willing and able to comply with study procedures
排除标准
- •Non-regional metastatic disease (stage IVc)
- •Previous malignancy within the last 5 years except for adequately treated basal or squamous cell carcinoma of the skin or cervical intra-epithelial neoplasia
- •Prior chemotherapy or radiotherapy for HNSCC, or any prior radiotherapy that would compromise delivery of a radical dose to the HNSCC
- •Known to be positive for hepatitis C or human immunodeficiency virus (HIV)
- •Unable to tolerate oral medication (unless a feeding tube is in place)
- •History of hypersensitivity to platinum drugs
- •Symptomatic peripheral neuropathy >= National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) grade II
- •Pregnant, lactating or unwilling to use adequate contraception
- •Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
- •Planned use of amifostine for prophylaxis against radiation-induced xerostomia
- •Patients taking selenium supplements in excess of 100 ug/day
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Evidence of any other significant medical disorder or laboratory finding that in the opinion of the Investigator compromises the subject's safety during the study
研究组 & 干预措施
Arm I (placebo, cisplatin, and radiotherapy)
Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.
干预措施: placebo (Other)
Arm I (placebo, cisplatin, and radiotherapy)
Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.
干预措施: cisplatin (Drug)
Arm I (placebo, cisplatin, and radiotherapy)
Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.
干预措施: radiation therapy (Radiation)
Arm I (placebo, cisplatin, and radiotherapy)
Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.
干预措施: quality-of-life assessment (Procedure)
Arm II (selenomethionine, cisplatin, and radiotherapy)
Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.
干预措施: selenomethionine (Dietary Supplement)
Arm II (selenomethionine, cisplatin, and radiotherapy)
Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.
干预措施: cisplatin (Drug)
Arm II (selenomethionine, cisplatin, and radiotherapy)
Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.
干预措施: radiation therapy (Radiation)
Arm II (selenomethionine, cisplatin, and radiotherapy)
Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.
干预措施: quality-of-life assessment (Procedure)
结局指标
主要结局
Incidence of >= Grade 3 Mucositis
时间窗: Up to 5 years
Will be compared as difference in proportions with 95% confidence intervals.
次要结局
- Tumor Complete Response Rate(Up to 5 years post-treatment)
- Relapse-free Survival (RFS)(At 1 year)
- Overall Survival(Up to 5 years post-treatment)
- Quality of Life(Up to 1 year post-treatment)
- Incidence of Grade 3 or 4 Treatment-related Toxicities, Including Xerostomia(Up to 5 years post-treatment)
- CRT Dose Delivery(Up to 8 weeks)
- Plasma Cisplatin and Selenium PK and PD Markers (NZ Only)(Up to 3 months post-treatment)