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Report for Clinical Trial NCT03567629

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Prospective, Open-lable, Multicenter, Randomized, Controlled Phase II Clinical Trial to Evaluate the Efficacy of Irinotecan Versus Oxaliplatin in the First-line Treatment of Refractory Metastatic Colorectal Cancer

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.

NCT03567629 mCRC
MeSH:Colorect Colorectal Neoplasms
HPO:Neoplasm of the large intestine

2 Interventions

Name: Irinotecan

Description: 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.
Type: Drug
Group Labels: 1

Irinotecan-based chemotherapy

Name: Oxaliplatin

Description: 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.
Type: Drug
Group Labels: 1

Oxaliplatin-based chemotherapy


Primary Outcomes

Description: Evaluation of the Progression-free Survival of Irinotecan-based regimen versus Oxaliplatin-based regimen in refractory metastatic colorectal cancer patients.

Measure: Progression-free Survival: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first.

Time: assessed up to 10 months

Secondary Outcomes

Description: Evaluation of the Overall Survival of Irinotecan-based regimen versus Oxaliplatin-based regimen in refractory metastatic colorectal cancer patients.

Measure: Overall Survival : From date of enrollment until the date of death.

Time: 2 years

Description: flurouracil drugs:fluorouracil、S1、Capecitabine

Measure: Evaluation of PFS in patients with different fluorouracil drugs and different genotyping subgroups.

Time: 10months

Description: flurouracil drugs:fluorouracil、S1、Capecitabine

Measure: Evaluation of OS in patients with different fluorouracil drugs and different genotyping subgroups.

Time: 2 years

Description: Adverse reactions evaluation is based on the National Cancer Institute adverse event General terminology Standard [CTCAE] 4.0 version

Measure: The incidence of treatment related emergent adverse events(Safety and Tolerance)

Time: Until 28 days after the deadline of enrollment

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 V600E

3. Subjects with BRAF V600E mutation. --- V600E ---



HPO Nodes


HPO: