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Trial record 7 of 159 for:    colon cancer AND Capecitabine AND Fluorouracil

Neoadjuvant Triplet Chemotherapy Regimen in Patients With Resectable Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT02688023
Recruitment Status : Recruiting
First Posted : February 23, 2016
Last Update Posted : February 23, 2016
Sponsor:
Collaborator:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Information provided by (Responsible Party):
Jing Huang, Chinese Academy of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: oxaliplatin;irinotecan;leucovorin;5-fluorouracil;capecitabine;S-1 Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Phase II Study of Triplet Chemotherapy Regimen in Neoadjuvant Chemotherapy of Patients With Resectable Colorectal Cancer
Study Start Date : March 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: single-arm Irinotecan-Oxaliplatin-5-Fluorouracil/leucovorin
Irinotecan,oxaliplatin and 5-fluorouracil/leucovorin(5-fluorouracil/leucovorin can be substituted with Capecitabine or S-1)
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.




Primary Outcome Measures :
  1. 3-year disease-free survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. objective response rate [ Time Frame: 2 years ]
  2. Surgical complete resection rate (R0) [ Time Frame: 2 years ]
  3. overall survival [ Time Frame: 6 years ]
  4. Number of participants with adverse events that are related to treatment [ Time Frame: 2 years ]
  5. Number of participants with surgery complications [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02688023


Contacts
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Contact: Jing Huang, M.D. 8610-87788103 huangjingwg@163.com

Locations
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China, Beijing
Cancer Institute and Hospital, Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China
Contact: Jing Huang, M.D.    8610-87788103    huangjingwg@163.com   
Principal Investigator: Zhixiang Zhou, M.D.         
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Investigators
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Principal Investigator: Jing Huang, M.D. Cancer Hospital, CAMS

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Responsible Party: Jing Huang, MD PhD, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT02688023     History of Changes
Other Study ID Numbers: CH-GI-052
First Posted: February 23, 2016    Key Record Dates
Last Update Posted: February 23, 2016
Last Verified: February 2016
Keywords provided by Jing Huang, Chinese Academy of Medical Sciences:
5-fluorouracil
Irinotecan
Oxaliplatin
Colorectal cancer
neoadjuvant
chemotherapy
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Capecitabine
Fluorouracil
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Oxaliplatin
Irinotecan
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs