Neoadjuvant Triplet Chemotherapy Regimen in Patients With Resectable Colorectal Cancer
NCT ID: NCT02688023
Last Updated: 2016-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
50 participants
INTERVENTIONAL
2014-03-31
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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single-arm Irinotecan-Oxaliplatin-5-Fluorouracil/leucovorin
Irinotecan,oxaliplatin and 5-fluorouracil/leucovorin(5-fluorouracil/leucovorin can be substituted with Capecitabine or S-1)
oxaliplatin;irinotecan;leucovorin;5-fluorouracil;capecitabine;S-1
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.
Interventions
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oxaliplatin;irinotecan;leucovorin;5-fluorouracil;capecitabine;S-1
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.
Eligibility Criteria
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Inclusion Criteria
* clinical stage T4N0-2M0、cT1-3N2M0 or M1(liver metastases only)
* age: 18-70 years
* ECOG 0-2
* adequate bone marrow, liver, renal and cardiac function (no history of ischemic heart disease)
* no prior cancer and/or chemotherapy
* signed informed consent
Exclusion Criteria
* pregnant or lactating patients
* known or suspected brain metastasis
18 Years
70 Years
ALL
No
Sponsors
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
OTHER
Chinese Academy of Medical Sciences
OTHER
Responsible Party
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Jing Huang
MD PhD
Principal Investigators
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Jing Huang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Cancer Hospital, CAMS
Locations
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CH-GI-052
Identifier Type: -
Identifier Source: org_study_id
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