FOLFIRI Versus Irinotecan as Second-line Treatment in Metastatic Colorectal Cancer Patients

Last updated: October 14, 2016
Sponsor: Fudan University
Overall Status: Trial Status Unknown

Phase

3

Condition

Colorectal Cancer

Cancer/tumors

Carcinoma

Treatment

N/A

Clinical Study ID

NCT02935764
FDZL-FCI
  • Ages 18-70
  • All Genders

Study Summary

This study is designed to compare the efficacy and safety of FOLFIRI regimen with irinotecan monodrug in the treatment of advanced colorectal cancer patients in the second-line setting.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • aged 18-70 years with histologically or cytologically confirmed advanced colorectaladenocarcinoma

  • Eastern Cooperative Oncology Group performance status of 0 to 2

  • life expectancy of ≥ 3 months

  • patients who had failed first-line treatment with either XELOX (capecitabine combinedwith oxaliplatin) or FOLFOX (5-fluorouracil/leucovorin with oxaliplatin)

  • at least one measurable disease lesion according to the Response Evaluation Criteriain Solid Tumors (RECIST 1.1) criteria

  • have adequate bone marrow, hepatic, and renal function

Exclusion

Exclusion Criteria:

  • patients with previous chronic inflammatory bowel disease, chronic diarrhea orrecurrent bowel obstruction

  • patients with symptomatic brain metastases

  • active clinical severe infection

  • previously received irinotecan

  • dihydropyrimidine dehydrogenase (DPD) enzyme adequate

Study Design

Total Participants: 164
Study Start date:
October 01, 2016
Estimated Completion Date: