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

Phase II Study of 2-weekly Raltitrexed Plus Irinotecan Regimen (RAILIRI) Versus Fluorouracil, Leucovorin, and Irinotecan Regimen (FOLFIRI) as Second-line Treatment in Advanced Colorectal Cancer Patients

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02376452

Enrollment

100

Registered

2015-03-03

Start date

2014-09-30

Completion date

2016-12-31

Last updated

2015-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Carcinoma

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.

Interventions

DRUGRaltitrexed

2mg/m2 iv gtt, d1

DRUGIrinotecan

180 mg/m2 iv gtt, d1

DRUG5-fluorouracil

5-FU 400mg/m2 iv, 2400mg/m2 civ 46h

DRUGLeucovorin

400mg/m2 iv gtt,d1

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
progression free survival	2 months

Secondary

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

Countries

China

Contacts

Primary ContactWen Zhang

8621-64175590-65242

Backup ContactWenhua Li

8621-64175590-65197

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026