Neoadjuvant Triplet Chemotherapy Regimen in Patients With Resectable Colorectal Cancer

Chinese Academy of Medical Sciences & Peking Union Medical College logo

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase

Unknown
Phase 2

Conditions

Colorectal Cancer

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT02688023
CH-GI-052

Details and patient eligibility

About

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.

Full description

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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

single-arm Irinotecan-Oxaliplatin-5-Fluorouracil/leucovorin
Experimental group
Description:
Irinotecan,oxaliplatin and 5-fluorouracil/leucovorin(5-fluorouracil/leucovorin can be substituted with Capecitabine or S-1)
Treatment:
Drug: oxaliplatin;irinotecan;leucovorin;5-fluorouracil;capecitabine;S-1

Trial contacts and locations

1

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Central trial contact

Jing Huang, M.D.

Data sourced from clinicaltrials.gov

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