Phase II Study of 2-weekly RAILIRI Versus FOLFIRI as Second-line Treatment in Advanced Colorectal Cancer Patients

Phase 2

• Conditions: Colorectal Carcinoma
• Interventions: Drug: Raltitrexed; Drug: Irinotecan; Drug: 5-fluorouracil; Drug: Leucovorin

• Registration Number: NCT02376452
• Lead Sponsor: Fudan University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Status Verified: 2015-02
• Study First Submitted: 2015-02-12
• Study First Submitted QC: 2015-03-02
• Last Update Submitted: 2015-03-02
• Study First Posted: 2015-03-03
• Last Update Posted: 2015-03-03
• Primary Completion: 2015-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• aged 18-70 years with histologically or cytologically confirmed advanced colorectal adenocarcinoma
• Eastern Cooperative Oncology Group performance status of 0 to 1
• 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 or raltitrexed
• dihydropyrimidine dehydrogenase (DPD) enzyme adequate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RALIRI	Raltitrexed	Raltitrexed combined with irinotecan
FOLFIRI	Leucovorin	5-fluorouracil,folinate combined with irinotecan
FOLFIRI	Irinotecan	5-fluorouracil,folinate combined with irinotecan
RALIRI	Irinotecan	Raltitrexed combined with irinotecan
FOLFIRI	5-fluorouracil	5-fluorouracil,folinate combined with irinotecan

Primary Outcome Measures

Name	Time	Method
progression free survival	2 months

Secondary Outcome Measures

Name	Time	Method
overall response rate	2 months
disease control rate	2 months
Number of Participants with Adverse Events	2 months
quality of life questionnaire	2 months
overall survival	6 months

Trial Locations

Locations (1)

Fudan University Cancer Hospital; 🇨🇳 ShangHai, Shanghai, China