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

October 19, 2017 updated by: Xianglin Yuan, Huazhong University of Science and Technology

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • Huazhong University of Science and Technology
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival of maintaining treatment（mPFS）
Time Frame: 5 years
mPFS defined as time from randomisation to progression after maintenance
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huazhong University of Science and Technology

Collaborators

The First Affiliated Hospital of Nanchang University
Henan Cancer Hospital
Hunan Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

June 1, 2019

Study Registration Dates

First Submitted

March 18, 2016

First Submitted That Met QC Criteria

March 23, 2016

First Posted (Estimate)

March 24, 2016

Study Record Updates

Last Update Posted (Actual)

October 23, 2017

Last Update Submitted That Met QC Criteria

October 19, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJCC005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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