Colorectal Neoplasms, Metastases
Conditions
Keywords
No prior chemotherapy
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.
Interventions
DRUGIrinotecan
Sponsors
Gachon University Gil Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Active infection and/or severe comorbidity * Known history of anaphylaxis of any origin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate after FOLFIRI reintroduction | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
| Overall survival | — |
Countries
South Korea
Outcome results
None listed