Neoadjuvant Triplet Chemotherapy Regimen in Patients With Resectable Colorectal Cancer
A Pilot Phase II Study of Triplet Chemotherapy Regimen in Neoadjuvant Chemotherapy of Patients With Resectable Colorectal Cancer
1 other identifier
interventional
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 colorectal-cancer
Started Mar 2014
Longer than P75 for phase_2 colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 11, 2016
CompletedFirst Posted
Study publicly available on registry
February 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedFebruary 23, 2016
February 1, 2016
4.8 years
February 11, 2016
February 17, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
3-year disease-free survival
5 years
Secondary Outcomes (5)
objective response rate
2 years
Surgical complete resection rate (R0)
2 years
overall survival
6 years
Number of participants with adverse events that are related to treatment
2 years
Number of participants with surgery complications
2 years
Study Arms (1)
single-arm Irinotecan-Oxaliplatin-5-Fluorouracil/leucovorin
EXPERIMENTALIrinotecan,oxaliplatin and 5-fluorouracil/leucovorin(5-fluorouracil/leucovorin can be substituted with Capecitabine or S-1)
Interventions
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
You may qualify if:
- histologically verified colorectal cancer
- 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
You may not qualify if:
- patients with a history of prior malignancy
- pregnant or lactating patients
- known or suspected brain metastasis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jing Huang, M.D.
Cancer Hospital, CAMS
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD
Study Record Dates
First Submitted
February 11, 2016
First Posted
February 23, 2016
Study Start
March 1, 2014
Primary Completion
December 1, 2018
Study Completion
December 1, 2019
Last Updated
February 23, 2016
Record last verified: 2016-02