Neoadjuvant Triplet Chemotherapy Regimen in Patients With Resectable Colorectal Cancer

NCT ID: NCT02688023

Last Updated: 2016-02-23

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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This is a single arm, phase 2 study of neoadjuvant triplet chemotherapy regimen of oxaliplatin, irinotecan combined with 5-fluorouraci/leucovorin or S-1 or capecitabine in patients with resectable colorectal cancer.Fifty patients will be enrolled in this trial. The primary objective of this study is to determine the 3-year disease-free survival of the patients.

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

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)

Group Type EXPERIMENTAL

oxaliplatin;irinotecan;leucovorin;5-fluorouracil;capecitabine;S-1

Intervention Type 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.

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* patients with a history of prior malignancy
* pregnant or lactating patients
* known or suspected brain metastasis
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role collaborator

Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Jing Huang

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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China

Central Contacts

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Jing Huang, M.D.

Role: CONTACT

8610-87788103

Facility Contacts

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Jing Huang, M.D.

Role: primary

8610-87788103

Other Identifiers

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CH-GI-052

Identifier Type: -

Identifier Source: org_study_id

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