A Randomized Investigation of Side Effects to FOLFOXIRI in Combination With Tocotrienol or Placebo as First Line Treatment of Metastatic Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Time to first serious adverse event
研究概览
简要总结
Treatment with FOLFOXIRI (5-fluorouracil, oxaliplatin, irinotecan) can be effective, but it has serious side effects, which may require hospitalization.
The purpose of this study is to investigate whether the addition of tocotrienol can reduce the side effects to FOLFOXIRI otherwise leading to hospitalization.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically verified colorectal adenocarcinoma.
- •Patients to receive first line treatment of metastatic disease, including potentially resectable or non-resectable disease
- •> 6 months without recurrence after end of adjuvant chemotherapy for radically treated stage II or III colorectal cancer
- •Disease evaluable according to RECIST 1.1, but not necessarily measurable disease.
- •Age 18-75 years
- •Performance status (PS) 0-
- •If age 71-75, then PS 0
- •Life expectancy > 3 months
- •Organ and bone marrow function as follows:
- •Neutrophil count ≥ 1.5 x 10^9/L
- •Thrombocytes ≥ 100 x 10^9/L
- •Total bilirubin ≤ 1.5 x upper level of normal (ULN)
- •Alanine transaminase (ALAT) ≤ 2.5 x ULN (or≤ 5 x ULN in case of liver metastases)
- •Fertile women must present negative pregnancy test. Male (with a female fertile partner) as well as female patients must use secure contraceptives during and 6 months after end of treatment.
- •Orally and written informed consent to treatment and biobank
排除标准
- •Primarily resectable metastases
- •Chemotherapy, radiotherapy or immunotherapy within 4 weeks
- •Known neuropathy ≥ grade 2
- •Serious competitive medical condition
- •Other concurrent malignant disease other than non-melanoma skin cancer
- •Previous serious and unexpected reactions to 5-fluorouracil, calcium folinate, oxaliplatin, irinotecan or capecitabine.
- •Hypersensitivity to one or more of the active substances or auxilliary agents
研究组 & 干预措施
Chemotherapy plus tocotrienol
Every 2 weeks: irinotecan 165 mg/m2 iv, oxaliplatin 85 mg/m2 iv, calcium folinate 200 mg/m2 iv, and 5-fluorouracil 3200 mg/m2 as a 46 hour infusion.
Daily: Tocotrienol 300 mg x 3 daily
干预措施: Irinotecan 165 mg/m2 iv (Drug)
Chemotherapy plus tocotrienol
Every 2 weeks: irinotecan 165 mg/m2 iv, oxaliplatin 85 mg/m2 iv, calcium folinate 200 mg/m2 iv, and 5-fluorouracil 3200 mg/m2 as a 46 hour infusion.
Daily: Tocotrienol 300 mg x 3 daily
干预措施: Oxaliplatin 85 mg/m2 iv (Drug)
Chemotherapy plus tocotrienol
Every 2 weeks: irinotecan 165 mg/m2 iv, oxaliplatin 85 mg/m2 iv, calcium folinate 200 mg/m2 iv, and 5-fluorouracil 3200 mg/m2 as a 46 hour infusion.
Daily: Tocotrienol 300 mg x 3 daily
干预措施: Calcium folinate 200 mg/m2 iv (Drug)
Chemotherapy plus tocotrienol
Every 2 weeks: irinotecan 165 mg/m2 iv, oxaliplatin 85 mg/m2 iv, calcium folinate 200 mg/m2 iv, and 5-fluorouracil 3200 mg/m2 as a 46 hour infusion.
Daily: Tocotrienol 300 mg x 3 daily
干预措施: 5-fluorouracil 3200 mg/m2 (Drug)
Chemotherapy plus tocotrienol
Every 2 weeks: irinotecan 165 mg/m2 iv, oxaliplatin 85 mg/m2 iv, calcium folinate 200 mg/m2 iv, and 5-fluorouracil 3200 mg/m2 as a 46 hour infusion.
Daily: Tocotrienol 300 mg x 3 daily
干预措施: Tocotrienol (Dietary Supplement)
Chemotherapy plus placebo
Every 2 weeks: irinotecan 165 mg/m2 iv, oxaliplatin 85 mg/m2 iv, calcium folinate 200 mg/m2 iv, and 5-fluorouracil 3200 mg/m2 as a 46 hour infusion.
Daily: Placebo x 3 daily
干预措施: Irinotecan 165 mg/m2 iv (Drug)
Chemotherapy plus placebo
Every 2 weeks: irinotecan 165 mg/m2 iv, oxaliplatin 85 mg/m2 iv, calcium folinate 200 mg/m2 iv, and 5-fluorouracil 3200 mg/m2 as a 46 hour infusion.
Daily: Placebo x 3 daily
干预措施: Oxaliplatin 85 mg/m2 iv (Drug)
Chemotherapy plus placebo
Every 2 weeks: irinotecan 165 mg/m2 iv, oxaliplatin 85 mg/m2 iv, calcium folinate 200 mg/m2 iv, and 5-fluorouracil 3200 mg/m2 as a 46 hour infusion.
Daily: Placebo x 3 daily
干预措施: Calcium folinate 200 mg/m2 iv (Drug)
Chemotherapy plus placebo
Every 2 weeks: irinotecan 165 mg/m2 iv, oxaliplatin 85 mg/m2 iv, calcium folinate 200 mg/m2 iv, and 5-fluorouracil 3200 mg/m2 as a 46 hour infusion.
Daily: Placebo x 3 daily
干预措施: 5-fluorouracil 3200 mg/m2 (Drug)
Chemotherapy plus placebo
Every 2 weeks: irinotecan 165 mg/m2 iv, oxaliplatin 85 mg/m2 iv, calcium folinate 200 mg/m2 iv, and 5-fluorouracil 3200 mg/m2 as a 46 hour infusion.
Daily: Placebo x 3 daily
干预措施: Placebo (Drug)
结局指标
主要结局
Time to first serious adverse event
时间窗: 6 months after the last patient has finished chemotherapy
次要结局
- Duration of non-planned hospitalizations calculated from date of first treatment until 1 month after completed chemotherapy(6 months after the last patient has finished chemotherapy)
- Number of patients with treatment related adverse events as assessed by CTCAE v.4.0(6 months after the last patient has finished chemotherapy)
- Death during treatment calculated from date of first treatment until 1 month after completed chemotherapy(6 months after the last patient has finished chemotherapy)
- Progression free survival(6 months after the last patient has finished chemotherapy)
- Quality of life as measured by combined questionnaire consisting of EORTC QLQ-C30 and CR29(6 months after the last patient has finished chemotherapy)
- Number of non-planned hospitalizations calculated from date of first treatment until 1 month after completed chemotherapy(6 months after the last patient has finished chemotherapy)
- Response rate(6 months after the last patient has finished chemotherapy)
- Overall survival(6 months after the last patient has finished chemotherapy)
- Resection rate(6 months after the last patient has finished chemotherapy)