Neoadjuvant Triplet Chemotherapy Regimen in Patients With Resectable Colorectal Cancer

Sponsor
Chinese Academy of Medical Sciences
Study ID
NCT02688023
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • oxaliplatin;irinotecan;leucovorin;5-fluorouracil;capecitabine;S-1 — DRUG
    The regimen consisted of irinotecan 150mg/m2 administered as an intravenous infusion on day 1, oxaliplatin 85 mg/m2 administered intravenously on day 2, leucovorin 200 mg intravenously on day 2, 5-fluorouracil 500 mg administered by intravenous bolus,followed by 2400 mg/m2 by 44 h continuous intravenous infusion starting on day 2. S-1 (40-60mg orally twice per day for 10 days) or capecitabine (1000mg/m2 orally twice per day for 10 days) can be substituted for intravenous 5-fluorouracil.14 days as a cycle, up to 4 cycles.

Study Details

Colorectal cancer is an aggressive malignancy with a poor overall outcome. The purpose of this study is to evaluate the feasibility, safety and efficacy of neoadjuvant oxaliplatin, irinotecan combined with 5-fluorouraci/leucovorin or S-1 or capecitabine in patients with resectable colorectal cancer.

Key Dates

Start date
Mar 31, 2014
Status verified
Feb 2016
Primary completion
Dec 31, 2018
Completion
Dec 31, 2019

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: single-arm Irinotecan-Oxaliplatin-5-Fluorouracil/leucovorin
    Irinotecan,oxaliplatin and 5-fluorouracil/leucovorin(5-fluorouracil/leucovorin can be substituted with Capecitabine or S-1)

Primary Outcome Measure

3-year disease-free survival [ Time Frame: 5 years ]

Central Contacts

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