A Single Arm, Open-label Clinical Trial to Evaluate the Efficacy and Safety of Maintenance Treatment With Capecitabine Plus Cetuximab in Metastatic Colorectal Cancer
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
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2014
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 18, 2016
CompletedFirst Posted
Study publicly available on registry
March 24, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedOctober 23, 2017
October 1, 2017
5 years
March 18, 2016
October 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival of maintaining treatment（mPFS）
mPFS defined as time from randomisation to progression after maintenance
5 years
Study Arms (1)
Maintenance Treatment
EXPERIMENTALA single arm of maintenance treatment with capecitabine plus cetuximab after first-line 5-fluorouracil based standard chemotherapy plus cetuximab.
Interventions
Using a maintenance treatment strategy of capecitabine plus cetuximab as a treatment option in mCRC after first-line 5-FU-based chemotherapy plus cetuximab
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Huazhong University of Science and Technologylead
- The First Affiliated Hospital of Nanchang Universitycollaborator
- Hunan Cancer Hospitalcollaborator
- Henan Cancer Hospitalcollaborator
Study Sites (1)
Huazhong University of Science and Technology
Wuhan, Hubei, 430000, China
Related Publications (3)
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.
PMID: 25862517BACKGROUNDHegewisch-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.
PMID: 26361971BACKGROUNDWang 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.
PMID: 32687588DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Chief physician
Study Record Dates
First Submitted
March 18, 2016
First Posted
March 24, 2016
Study Start
January 1, 2014
Primary Completion
January 1, 2019
Study Completion
June 1, 2019
Last Updated
October 23, 2017
Record last verified: 2017-10