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

Fudan University

Status and phase: Unknown; Phase 2

Conditions: Colorectal Carcinoma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02376452

RALIRI

Details and patient eligibility

About

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.

Enrollment: 100 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups, including a placebo group

RALIRI

Experimental group

Description:

Raltitrexed combined with irinotecan

Treatment:

Drug: Irinotecan

Drug: Raltitrexed

FOLFIRI

Placebo Comparator group

Description:

5-fluorouracil,folinate combined with irinotecan

Treatment:

Drug: 5-fluorouracil

Drug: Irinotecan

Drug: Leucovorin