Neoadjuvant Triplet Chemotherapy Regimen in Patients With Resectable Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

A Pilot Phase II Study of Triplet Chemotherapy Regimen in Neoadjuvant Chemotherapy of Patients With Resectable Colorectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02688023
• Other study ID #: CH-GI-052
• Status: Recruiting
• Phase: Phase 2
• First received: February 11, 2016
• Last updated: February 17, 2016
• Start date: March 2014
• Est. completion date: December 2019

Study information

• Verified date: February 2016
• Source: Chinese Academy of Medical Sciences
• Contact: Jing Huang, M.D.
• Phone: 8610-87788103
• Email: huangjingwg[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences	Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year disease-free survival		5 years	Yes
Secondary	objective response rate		2 years	No
Secondary	Surgical complete resection rate (R0)		2 years	No
Secondary	overall survival		6 years	No
Secondary	Number of participants with adverse events that are related to treatment		2 years	Yes
Secondary	Number of participants with surgery complications		2 years	Yes