A Trial Comparing Pre-operative Chemo-radiotherapy With Cisplatin and Fluorouracil Versus Chemotherapy With Docetaxel and Irinotecan in PET Non Responders Resectable Cancer Esophagus: a Multicenter Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Pathological Complete Response ( regression score 1a- see response assessment) in each treatment group
研究概览
简要总结
The purpose of this study is to improve their outcome by either changing the chemotherapy drugs or giving them radiation therapy with concurrent chemotherapy, hoping that this will improve their outcome.
详细描述
This study is aimed at improving the outcome of resectable non PET responders, esophageal carcinoma, by either changing the chemotherapy drugs or giving them radiation therapy with concurrent chemotherapy, hoping that this will improve their outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 14 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven squamous cell or adenocarcinoma of the thoracic esophagus and gastro-esophageal junction.
- •No distant metastases.
- •Signed written informed consent.
- •Age less than 75 years.
- •Potentially resectable tumor (radiological evidence of resection with no residual disease).
- •ECOG 0 to
- •Normal serum creatinine and adequate hepatic function, serum bilirubin less than 30 mmol/l, serum alkaline phosphatase less than 2 times upper limit of normal and ALT and AST of less than 4 upper limits of normal.
- •Normal bone marrow function with absolute neutrophile count of more than 1500/ml, hemoglobin more than 80 gm/L and platelets more than 100,000 /ml
排除标准
- •Serious underlying medical condition which could impair the patient ability to participate in the clinical trial or comply to follow up
- •Prior treatment with other anti cancer therapy or radiation therapy.
- •Legal incapacity.
- •Previous malignancy within 5 years except adequately treated non melanomatous skin cancer or in situ cervical cancer.
- •Psychiatric or mental disorder precluding the understanding of the information of the trial topics and giving valid informed consent.
研究组 & 干预措施
Arm B
Arm B will receive combination of cisplatin, fluorouracil and concurrent radiation therapy 50 Gy in 25 fractions over 5 weeks with cisplatin 75 mg/m2 on first day of week 1 and week 5 and fluorouracil 750 mg/m2 daily by continuous intra venous infusion at Day 1 and Day 29 of Radiation therapy for 4 days.
PET scan will be repeated 3-4 weeks after end of concurrent chemo-radiation therapy Patients in Arm A and B will go for esophagectomy 4-6 weeks after end of concurrent chemo-radiation therapy or chemotherapy
干预措施: Cisplatin, fluorouracil and concurrent radiation therapy (Drug)
Arm A
Arm A: will receive combination of irinotecan and docetaxel regimen for 2 cycles, recycling every 21 days Irinotecan 100 mg/m2 by intra venous infusion over 2 hours in day1 and docetaxel 40 mg/m2 over one hour will be given on day 1 Assessment by PET scan and CT chest and abdomen will be done 2-3 weeks after end of 2nd cycle of irinotecan and docetaxel
干预措施: irinotecan and docetaxel (Drug)
结局指标
主要结局
Pathological Complete Response ( regression score 1a- see response assessment) in each treatment group
时间窗: 5 yrs
次要结局
- Rate of conversion from PET non responder to responder with each type of salvage therapy(5 yrs)