This is a prospective, open-lable, multicenter, randomized, controlled, phase II clinical study. The aim is to evaluate the efficacy of Irinotecan versus Oxaliplatin in the first-line treatment of refractory metastatic colorectal cancer.
This trial is conducted in patients with the refractory metastatic colorectal cancer. Eligible patients are randomized into two arms at 1:1 ratio to receive Irinotecan-based regimen or Oxaliplatin-based regimen until progress of the disease, unacceptable toxicity or withdrawal of consent by the patient. Study evaluation time is until death of patient or a deadline set by the researchers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
Irinotecan 180 mg / m2, intravenous drip, D1, combined with fluorouracil / calcium folinate or Capecitabine or S1; combine or not combine with Bevacizumab or Cetuximab; every 14 days for a cycle.
Oxaliplatin 85mg/m2 (two-week regimen) or 130mg/m2 (three week regimen), intravenous drip, D1, combined with fluorouracil / calcium folinate or Capecitabine or S1; combine or not combine with Bevacizumab or Cetuximab; every 14 or 21 days for a cycle.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Progression-free Survival: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first.
Evaluation of the Progression-free Survival of Irinotecan-based regimen versus Oxaliplatin-based regimen in refractory metastatic colorectal cancer patients.
Time frame: assessed up to 10 months
Overall Survival : From date of enrollment until the date of death.
Evaluation of the Overall Survival of Irinotecan-based regimen versus Oxaliplatin-based regimen in refractory metastatic colorectal cancer patients.
Time frame: 2 years
Evaluation of PFS in patients with different fluorouracil drugs and different genotyping subgroups.
flurouracil drugs:fluorouracil、S1、Capecitabine
Time frame: 10months
Evaluation of OS in patients with different fluorouracil drugs and different genotyping subgroups.
flurouracil drugs:fluorouracil、S1、Capecitabine
Time frame: 2 years
The incidence of treatment related emergent adverse events(Safety and Tolerance)
Adverse reactions evaluation is based on the National Cancer Institute adverse event General terminology Standard \[CTCAE\] 4.0 version
Time frame: Until 28 days after the deadline of enrollment
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