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Trial record 83 of 435 for:    colon cancer AND Capecitabine

A Single Arm, Open-label Clinical Trial to Evaluate the Efficacy and Safety of Maintenance Treatment With Capecitabine Plus Cetuximab in Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02717923
Recruitment Status : Unknown
Verified October 2017 by Xianglin Yuan, Huazhong University of Science and Technology.
Recruitment status was:  Recruiting
First Posted : March 24, 2016
Last Update Posted : October 23, 2017
Sponsor:
Collaborators:
The First Affiliated Hospital of Nanchang University
Hunan Cancer Hospital
Henan Cancer Hospital
Information provided by (Responsible Party):
Xianglin Yuan, Huazhong University of Science and Technology

Brief Summary:
This is a single arm, open-label, multi-center clinical trial to evaluate the efficacy and safety of maintenance treatment with capecitabine plus cetuximab after first-line 5-fluorouracil-based chemotherapy plus cetuximab for patients with RAS wild-type metastatic colorectal cancer.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Other: maintenance treatment with capecitabine plus cetuximab Phase 2

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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: Maintenance Treatment With Capecitabine Plus Cetuximab After First-line 5-Fluorouracil-based Chemotherapy Plus Cetuximab for Patients With RAS Wild-type Metastatic Colorectal Cancer: a Single Arm, Open-label, Multi-center Clinical Trial
Study Start Date : January 2014
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Maintenance Treatment
A single arm of maintenance treatment with capecitabine plus cetuximab after first-line 5-fluorouracil based standard chemotherapy plus cetuximab.
Other: maintenance treatment with capecitabine plus cetuximab
Using a maintenance treatment strategy of capecitabine plus cetuximab as a treatment option in mCRC after first-line 5-FU-based chemotherapy plus cetuximab




Primary Outcome Measures :
  1. Progression-Free Survival of maintaining treatment(mPFS) [ Time Frame: 5 years ]
    mPFS defined as time from randomisation to progression after maintenance



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects has been fully understand this research and volunteered to sign the consent form;
  2. Histologically and/or cytologically diagnosed with RAS wild-type metastatic metastatic colorectal cancer(Phase IIIc/IV), any other histological type is excluded;
  3. Subjects with stable disease or better after induction treatment with eight to twelve 2-weekly cycles of 5FU-based standard chemotherapy;
  4. ECOG Performance Status (ECOG PS) ≤1(0-1);
  5. Evident measurable lesion(s) that meets the Response Evaluation Criteria in Solid Tumors (RECIST 1.1);
  6. Expected survival>16 weeks.

Exclusion Criteria:

  1. Subjects with presence of clinically detectable second primary malignant tumors at the enrollment, or other malignant tumors within the last 5 years (excluding adequately treated skin basal cell carcinoma or carcinoma in situ of cervix);
  2. Clinical refractory diseases(including uncontrolled epilepsy),and affect survivor;
  3. Central Nervous System (CNS) metastatic disease or prior cerebral metastasis;
  4. Researchers think that the subjects exist any clinical or laboratory abnormalities or compliance issues and not suitable to participate in this clinical study.

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): NCT02717923


Contacts
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Contact: Xianglin Yuan, Professional 13667241722 yxl@medmail.com.cn
Contact: Ben Zhao, Master 15071206621 zhaoben0609@163.com

Locations
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China, Hubei
Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430000
Contact: Xianglin Yuan, Professional    13667241722    yxl@medmail.com.cn   
Contact: Ben Zhao, Master    15071206621    zhaoben0609@163.com   
Sponsors and Collaborators
Huazhong University of Science and Technology
The First Affiliated Hospital of Nanchang University
Hunan Cancer Hospital
Henan Cancer Hospital

Publications:
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Responsible Party: Xianglin Yuan, Professor, Chief physician, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT02717923     History of Changes
Other Study ID Numbers: TJCC005
First Posted: March 24, 2016    Key Record Dates
Last Update Posted: October 23, 2017
Last Verified: October 2017
Keywords provided by Xianglin Yuan, Huazhong University of Science and Technology:
metastatic colorectal cancer
maintenance treatment
cetuximab
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Capecitabine
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Fluorouracil
Cetuximab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological