Comparison Between Two Regimens of Chemotherapy Concurrent With Radiotherapy in Locally Advanced Head and Neck Cancer
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Loco-regional tumor control after completion of treatment
研究概览
简要总结
The aim of this study is to compare treatment responses and toxicities of concurrent chemo-radiation with weekly and three weekly Cisplatin in locally advanced Head & Neck Cancer. Half of the participants received Cisplatin (40 mg/m2) weekly with radiotherapy, while the other half received Cisplatin (100 mg/m2) thrice weekly with radiotherapy. Radiotherapy continued five days per week for six and half weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Biopsy proved, previously untreated, Squamous cell carcinoma of head & neck
- •Stages III to IVB
排除标准
- •Patients with history of prior chemotherapy or radiotherapy to the head and neck region.
- •Initial surgery (excluding diagnostic biopsy) of the primary site.
- •Patients with synchronous primaries.
- •Those who are not willing to be included in the study.
- •Pregnant or lactating woman.
- •Serious medical illness
- •Prisoners.
研究组 & 干预措施
Weekly Cisplatin
Inj. Cisplatin 40 mg /m2 intravenous infusion delivered concurrently with radiotherapy on a weekly basis.
干预措施: Cisplatin 40 mg/m2 (Drug)
Three weekly Cisplatin
Inj. Cisplatin 100 mg/m2 intravenous infusion delivered on a three weekly basis on days 1, 22 and 43 delivered concurrently with radiotherapy.
干预措施: Cisplatin 100 mg/m2 (Drug)
结局指标
主要结局
Loco-regional tumor control after completion of treatment
时间窗: 6 months
Response Evaluation Criteria in Solid Tumors was used to measure outcome: 1. Complete response (CR): Disappearance of all target lesions. 2. Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions. 3. Progressive disease (PD): At least a 20% increase in the sum of diameters of target lesions. 4. Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Treatment related toxicities during and after treatment
时间窗: 8 months
National Cancer Institute's Common Terminology Criteria for Advanced Events (version 4.03) was used measure toxicities.
次要结局
未报告次要终点
研究者
Dr. Ishtiaq-Ur-Rahim
Principal Investigator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh