A Randomised Study of Sequential Versus Combination Chemotherapy in Patients With Previously Untreated Advanced Colorectal Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 820
- 主要终点
- Overall survival
研究概览
简要总结
Primary objective:To assess the efficacy, defined as overall survival, of sequential versus combination chemotherapy for advanced colorectal cancer (CRC).
Methodology Open, randomised multicenter phase III study. Randomisation by centre will be centralized. 820 patiënts with histologically proven advanced CRC; not amenable to curative surgery. Measurable or evaluable disease. Age 18 years and above. WHO performance status 0-2.
Test products:
Arm A: First line: capecitabine capecitabine 1250 mg/m2 orally b.i.d. on day 1-14 (q3),until progression or unacceptable toxicity. Second line: irinotecan 350 mg/m2 IV infusion on day 1 (q3),until progression or unacceptable toxicity. Third line: oxaliplatin 130 mg/m2 IV infusion on day 1 and capecitabine 1000 mg/m2 orally b.i.d. on day 1-14 (q3). Arm B: First line: irinotecan 250 mg/m2 IV infusion in 30 minutes on day 1 and capecitabine 1000 mg/m2 orally b.i.d. on day 1-14 (q3), until progression or unacceptable toxicity. Second line: oxaliplatin 130 mg/m2 IV on day 1 and capecitabine 1000 mg/m2 orally b.i.d. on day 1-14 (q3), until progression or unacceptable toxicity.
Patients will be followed by CT-scan every 9 weeks for response while on treatment, or at any other moment when progression is suspected. After cessation of chemotherapy, patients will be followed every 3 months until death. Clinical and laboratory toxicity/symptomatology will be graded according to NCI common criteria.
详细描述
Objectives: Primary objective:
To assess the efficacy, defined as overall survival, of sequential versus combination chemotherapy for advanced CRC.
Secondary objectives are to assess:
To assess Tumour response (CR, PR or SD) Progression free survival Quality of life Toxicity profile Methodology Open, randomised multicenter phase III study. Randomisation by centre will be centralized by IKC. Number of patients 820 Main criteria for inclusion Histology and staging disease
- Histologically proven advanced CRC; not amenable to curative surgery;
- Of Note: In case of a single metastasis, histological or cytological proof of colorectal carcinoma should be obtained prior to randomisation.
- Measurable or evaluable disease. Serum CEA as the only parameter for disease activity is not allowed.
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
- None
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
- •Histology and staging disease
- •Histologically proven CRC; advanced disease, not amenable to curative surgery;
- •Of Note: In case of a single metastasis, histological or cytological proof of colorectal carcinoma should be obtained prior to randomisation.
- •Measurable or evaluable disease; Serum CEA as the only parameter for disease activity is not allowed.
- •General conditions
- •Written informed consent;
- •Age 18 years and above;
- •WHO performance status 0-2;
- •Adequate bone marrow function(WBC > 3.0 x 109/L, platelets > 100 x 109/L, Hb > 6 mmol/L);
- •Adequate hepatic function: total bilirubin <
- •5 x upper normal limit, ASAT and ALAT < 3 x upper normal limits; in case of liver metastases < 5 x upper normal limits
- •Adequate renal function: creatinin <
- •5 x upper normal limits.
- •Other - Expected adequacy of follow-up.
排除标准
- •General conditions
- •Pregnancy or lactation;
- •Patients (M/F) with reproductive potential not implementing adequate contraceptives measures.
- •Prior or current history
- •Prior chemotherapy for advanced disease; prior adjuvant chemotherapy is allowed provided that the last administration was given > 6 months prior to randomisation.
- •Serious concomitant diseases preventing the safe administration of chemotherapy or likely to interfere with the study assessments;
- •Serious active infections;
- •Inflammatory bowel disease or other diseases associated with chronic diarrhoea;
- •Previous extensive irradiation of the pelvis or abdomen;
- •Other malignancies in the past 5 years with the exception of adequately treated carcinoma in situ of the cervix or squamous or basal cell carcinoma of the skin.
- •Concomitant treatments
- •Concomitant (or within 4 weeks before randomisation) administration of any other experimental drug under investigation;
- •Concurrent treatment with any other anti-cancer therapy.
研究组 & 干预措施
1Capecitabine-irinotecan
1st line- 2nd line (3rd line oxaliplatin plus capecitabine)
干预措施: capecitabine-irinotecan (Drug)
2capecitabine plus irinotecan
1st line (2nd line oxaliplatin plus capecitabine)
干预措施: capecitabine+irinotecan (1st line) (Drug)
结局指标
主要结局
Overall survival
时间窗: study duration
次要结局
- Tumour response(study duration)
- Progression free survival(study duration)
- Quality of life(study duration)
- Toxicity profile(study duration)