Irinotecan Discontinuation and Reintroduction for Advanced Colorectal Cancer
- Conditions
- Colorectal NeoplasmsMetastases
- Registration Number
- NCT00320320
- Lead Sponsor
- Gachon University Gil Medical Center
- Brief Summary
The purpose of this study is to evaluate the feasibility and efficacy of first-line FOLFIRI discontinuation after initial 8 cycles and reintroduction after progression.
- Detailed Description
For medically-fit patients with advanced colorectal cancer, the current standard approach is chemotherapy with FOLFIRI or FOLFOX. Although a strategy of using sequential 5-FU, irinotecan and oxaliplatin has been thought to maximize overall survival in such patients, significant toxicity remains a problem. It has been suggested feasible that chemotherapy can be discontinued after 2-3 months and restart same treatment on progression in patients with chemosensitive colorectal cancer. Thus we designed this pilot phase II study to evaluate the feasibility and efficacy of first-line FOLFIRI discontinuation after initial 8 cycles and reintroduction after progression.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 72
- Histologically proven adenocarcinoma of colon and rectum
- No prior chemotherapy or only adjuvant chemotherapy and/or radiotherapy
- Advanced, metastatic or recurrent not amenable to curative local therapy
- Measurable lesion(s)
- ECOG performance status 0 to 2
- Normal marrow, hepatic and renal function
- Provision of written informed consent
- Active infection and/or severe comorbidity
- Known history of anaphylaxis of any origin
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Response rate after FOLFIRI reintroduction
- Secondary Outcome Measures
Name Time Method Progression-free survival Overall survival
Trial Locations
- Locations (1)
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of