This is a single-arm, open-label, single-center prospective phase II study to evaluate the efficacy and safety of rechallenge chemotherapy in the third or later-line treatment in patients with advanced colorectal cancer. The primary end point is progression free survival (PFS). A total of 42 patients who failed with oxaliplatin, irinotecan and fluorouracil in previous treatment and could not receive the target therapy presently are planned for recruitment. For patients with metastatic colorectal cancer who met admission criteria, oxaliplatin- or irinotecan-based chemo regimen could be used and evaluation was repeated every 6 weeks. The treatment continues until the disease progression or the untolerable adverse reaction.
The treatment for reintroduction was oxaliplatin- or irinotecan-based chemo-regimen. Optional chemotherapy regimen included XELOX,FOLFOX,FOLFIRI,Irinotecan single-agent
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
43
XELOX regimen: Oxaliplatin 130mg/m2, intravenous, on day 1; Capecitabine 1000mg/m2, oral, twice daily, continuously for 14 days; ±bevacizumab 7.5mg/kg, intravenous, on day 1; repeating every 3 weeks. FOLFOX regimen: Oxaliplatin 85mg/m2 on day 1; Calcium folinate 400mg/m2 on day 1; 5-FU 400mg/m2 on day 1; 5-FU 2.4g/m2, continuous intravenous infusion for 46 hours, ± Bevacizumab 5mg/kg or ± Cetuximab 500mg/m2, repeating every 2 weeks. FOLFIRI regimen: Irinotecan 180mg/m2 on day 1; Calcium folinate 400mg/m2 on day 1; 5-FU 400mg/m2 on day 1; 5-FU 2.4g/m2, continuous intravenous infusion for 46 hours; ± Bevacizumab 5mg/kg or ± Cetuximab 500mg/m2, repeating every 2 weeks. Irinotecan monotherapy regimen: Irinotecan 180mg/m2 on day 1, ± Bevacizumab 5mg/kg or ± Cetuximab 500mg/m2, repeating every 2 weeks. Raltitrexed contained regimen: Raltitrexed 3mg/m2 on day 1; ± Bevacizumab 7.5mg/kg, repeating every 3 weeks; Raltitrexed 2mg/m2 on day 1; ± Cetuximab 500mg/m2, repeating every 2 weeks.
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
PFS
progression free survival
Time frame: from the time signing of informed consent form(ICF) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
OS
overall survival
Time frame: from the time signing of ICF until the date of death from any cause, assessed up to 48 months
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