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

Peking University1 site in 1 country130 target enrollmentMay 29, 2018

ConditionsmCRC

InterventionsIrinotecan Oxaliplatin

DrugsIrinotecan Oxaliplatin

Overview

Phase: Phase 2
Intervention: Irinotecan
Conditions: mCRC
Sponsor: Peking University
Enrollment: 130
Locations: 1
Primary Endpoint: Progression-free Survival: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first.
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

May 29, 2018

End Date

December 30, 2023

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Peking University

Responsible Party

Principal Investigator

Shen Lin

Head of Head of department of Gastrointestinal oncology

Peking University

Eligibility Criteria

Inclusion Criteria

•Histopathological diagnosis of metastatic colorectal adenocarcinoma.
•At least one measurable or assessable lesion that meet RECIST criteria.
•Accord with standard for refractory colorectal cancer (The standard for refractory colorectal cancer can be met if one of the following conditions is met)
•(1) Right colon cancer. (2) Mucinous adenocarcinoma or signet ring cell carcinoma. (3) Complicated by peritoneal metastasis. (4) MSI-H or dMMR, immune checkpoint inhibitor therapy is not acceptable.
•Male or female, age≥18 years old.
•Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-
•Life expectancy \>3 months
•Adequate organ function as indicated by the following laboratory values:
•Serum total bilirubin ≤ 1.5 X upper limit of the normal (ULN)
•Absolute neutrophil count (ANC) ≥1,500 /µL（1.5×109 /L）

Exclusion Criteria

•Received palliative chemotherapy, such as adjuvant chemotherapy, recurrence within 12 months after adjuvant chemotherapy.
•Metastatic lesion is subject to be treated by local intervention.
•Subjects with BRAF V600E mutation.
•Presence of other active malignancies or a history of other malignancies within the past 5 years, except for carcinoma in situ of the cervix, basal cell carcinoma of the skin that has been previously treated with curative intent.
•Subjects with cerebral metastasis, spinal cord compression, carcinomatous meningitis, CT /MRI examination reveals diseases of the brain or pia mater during screening.
•Subjects with chronic diarrhea, intestinal obstruction or incomplete intestinal obstruction, or severe peripheral nerve disease.
•Any of the following diseases occurred in the 12 months before the study: Myocardial infarction, severe / unstable angina pectoris, coronary artery / peripheral artery bypass grafting, symptomatic congestive heart failure, cerebrovascular accident, or transient ischemic attack, or pulmonary embolism within 6 months
•Subject is known to be infected with Immunodeficiency virus (HIV) or associated with acquired immune deficiency syndrome (AIDS).
•Subject is enrolled in other clinical trials currently.
•Pregnant or lactating women; women of potential childbearing age and male subjects do not use effective contraception during the study period.

Arms & Interventions

Irinotecan-based chemotherapy

Intervention: Irinotecan

Oxaliplatin-based chemotherapy

Intervention: Oxaliplatin

Outcomes

Primary Outcomes

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 Frame: assessed up to 10 months

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

Secondary Outcomes

Overall Survival : From date of enrollment until the date of death.(2 years)
Evaluation of PFS in patients with different fluorouracil drugs and different genotyping subgroups.(10months)
Evaluation of OS in patients with different fluorouracil drugs and different genotyping subgroups.(2 years)
The incidence of treatment related emergent adverse events（Safety and Tolerance）(Until 28 days after the deadline of enrollment)