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

Fudan University

Status and phase: Unknown; Phase 3

Conditions: Colorectal Carcinoma

Treatments: Drug: 5-fluorouracil; Drug: Leucovorin; Drug: Irinotecan

Study type: Interventional

Funder types: Other

Identifiers

NCT02935764

FDZL-FCI

Details and patient eligibility

About

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.

Enrollment: 164 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• aged 18-70 years with histologically or cytologically confirmed advanced colorectal adenocarcinoma
• 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 combined with oxaliplatin) or FOLFOX (5-fluorouracil/leucovorin with oxaliplatin)
• at least one measurable disease lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria
• have adequate bone marrow, hepatic, and renal function

Exclusion criteria

• patients with previous chronic inflammatory bowel disease, chronic diarrhea or recurrent bowel obstruction
• patients with symptomatic brain metastases
• active clinical severe infection
• previously received irinotecan
• dihydropyrimidine dehydrogenase (DPD) enzyme adequate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

164 participants in 2 patient groups

FOLFIRI

Experimental group

Description:

5-fluorouracil,folinate combined with irinotecan

Treatment:

Drug: Leucovorin

Drug: 5-fluorouracil

Drug: Irinotecan

IRINOTECAN

Active Comparator group

Description:

irinotecan

Treatment:

Drug: Irinotecan