Back to resultsA Single Arm, Open-label Clinical Trial to Evaluate the Efficacy and Safety of Maintenance Treatment With Capecitabine Plus Cetuximab in Metastatic Colorectal Cancer
Primary Purpose
Colorectal Neoplasms
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
maintenance treatment with capecitabine plus cetuximab
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Neoplasms focused on measuring metastatic colorectal cancer, maintenance treatment, cetuximab
Eligibility Criteria
Inclusion Criteria:
- Subjects has been fully understand this research and volunteered to sign the consent form;
- Histologically and/or cytologically diagnosed with RAS wild-type metastatic metastatic colorectal cancer(Phase IIIc/IV), any other histological type is excluded;
- Subjects with stable disease or better after induction treatment with eight to twelve 2-weekly cycles of 5FU-based standard chemotherapy;
- ECOG Performance Status (ECOG PS) ≤1(0-1);
- Evident measurable lesion(s) that meets the Response Evaluation Criteria in Solid Tumors (RECIST 1.1);
- Expected survival>16 weeks.
Exclusion Criteria:
- 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);
- Clinical refractory diseases(including uncontrolled epilepsy),and affect survivor;
- Central Nervous System (CNS) metastatic disease or prior cerebral metastasis;
- Researchers think that the subjects exist any clinical or laboratory abnormalities or compliance issues and not suitable to participate in this clinical study.
Sites / Locations
- Huazhong University of Science and TechnologyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Maintenance Treatment
Arm Description
A single arm of maintenance treatment with capecitabine plus cetuximab after first-line 5-fluorouracil based standard chemotherapy plus cetuximab.
Outcomes
Primary Outcome Measures
Progression-Free Survival of maintaining treatment（mPFS）
mPFS defined as time from randomisation to progression after maintenance
Secondary Outcome Measures
Full Information
NCT ID
NCT02717923
First Posted
March 18, 2016
Last Updated
October 19, 2017
Sponsor
Huazhong University of Science and Technology
Collaborators
The First Affiliated Hospital of Nanchang University, Hunan Cancer Hospital, Henan Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02717923
Brief Title
A Single Arm, Open-label Clinical Trial to Evaluate the Efficacy and Safety of Maintenance Treatment With Capecitabine Plus Cetuximab in Metastatic Colorectal Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huazhong University of Science and Technology
Collaborators
The First Affiliated Hospital of Nanchang University, Hunan Cancer Hospital, Henan Cancer Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
Keywords
metastatic colorectal cancer, maintenance treatment, cetuximab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Maintenance Treatment
Arm Type
Experimental
Arm Description
A single arm of maintenance treatment with capecitabine plus cetuximab after first-line 5-fluorouracil based standard chemotherapy plus cetuximab.
Intervention Type
Other
Intervention Name(s)
maintenance treatment with capecitabine plus cetuximab
Intervention Description
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 Measure Information:
Title
Progression-Free Survival of maintaining treatment（mPFS）
Description
mPFS defined as time from randomisation to progression after maintenance
Time Frame
5 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects has been fully understand this research and volunteered to sign the consent form;
Histologically and/or cytologically diagnosed with RAS wild-type metastatic metastatic colorectal cancer(Phase IIIc/IV), any other histological type is excluded;
Subjects with stable disease or better after induction treatment with eight to twelve 2-weekly cycles of 5FU-based standard chemotherapy;
ECOG Performance Status (ECOG PS) ≤1(0-1);
Evident measurable lesion(s) that meets the Response Evaluation Criteria in Solid Tumors (RECIST 1.1);
Expected survival>16 weeks.
Exclusion Criteria:
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);
Clinical refractory diseases(including uncontrolled epilepsy),and affect survivor;
Central Nervous System (CNS) metastatic disease or prior cerebral metastasis;
Researchers think that the subjects exist any clinical or laboratory abnormalities or compliance issues and not suitable to participate in this clinical study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xianglin Yuan, Professional
Phone
13667241722
Email
yxl@medmail.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Ben Zhao, Master
Phone
15071206621
Email
zhaoben0609@163.com
Facility Information:
Facility Name
Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xianglin Yuan, Professional
Phone
13667241722
Email
yxl@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Ben Zhao, Master
Phone
15071206621
Email
zhaoben0609@163.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
25862517
Citation
Simkens LH, van Tinteren H, May A, ten Tije AJ, Creemers GJ, Loosveld OJ, de Jongh FE, Erdkamp FL, Erjavec Z, van der Torren AM, Tol J, Braun HJ, Nieboer P, van der Hoeven JJ, Haasjes JG, Jansen RL, Wals J, Cats A, Derleyn VA, Honkoop AH, Mol L, Punt CJ, Koopman M. Maintenance treatment with capecitabine and bevacizumab in metastatic colorectal cancer (CAIRO3): a phase 3 randomised controlled trial of the Dutch Colorectal Cancer Group. Lancet. 2015 May 9;385(9980):1843-52. doi: 10.1016/S0140-6736(14)62004-3. Epub 2015 Apr 7.
Results Reference
background
PubMed Identifier
26361971
Citation
Hegewisch-Becker S, Graeven U, Lerchenmuller CA, Killing B, Depenbusch R, Steffens CC, Al-Batran SE, Lange T, Dietrich G, Stoehlmacher J, Tannapfel A, Reinacher-Schick A, Quidde J, Trarbach T, Hinke A, Schmoll HJ, Arnold D. Maintenance strategies after first-line oxaliplatin plus fluoropyrimidine plus bevacizumab for patients with metastatic colorectal cancer (AIO 0207): a randomised, non-inferiority, open-label, phase 3 trial. Lancet Oncol. 2015 Oct;16(13):1355-69. doi: 10.1016/S1470-2045(15)00042-X. Epub 2015 Sep 8. Erratum In: Lancet Oncol. 2015 Dec;16(16):e589.
Results Reference
background
PubMed Identifier
32687588
Citation
Wang L, Liu Y, Yin X, Fang W, Xiong J, Zhao B, Zhang M, Zou Y, Qiu H, Yuan X. Effect of Reduced-Dose Capecitabine Plus Cetuximab as Maintenance Therapy for RAS Wild-Type Metastatic Colorectal Cancer: A Phase 2 Clinical Trial. JAMA Netw Open. 2020 Jul 1;3(7):e2011036. doi: 10.1001/jamanetworkopen.2020.11036.
Results Reference
derived
Learn more about this trial
A Single Arm, Open-label Clinical Trial to Evaluate the Efficacy and Safety of Maintenance Treatment With Capecitabine Plus Cetuximab in Metastatic Colorectal Cancer
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