Cetuximab Monotherapy Maintenance Treatment in mCRC
Biomarker-Panel Enriched Maintenance Treatment With Cetuximab Monotherapy Versus Continuation After Induction Treatment With Chemotherapy + Cetuximab in Metastatic Colorectal Cancer (mCRC)
1 other identifier
interventional
500
0 countries
N/A
Brief Summary
Investigating the efficacy of Cetuximab Monotherapy versus Continuation after induction treatment with chemotherapy + Cetuximab in inoperable or irresectable and non-progressive metastatic colorectal cancer after first line induction treatment for 24 weeks with mFOLFOX6/FOLFIRI and Cetuximab treatment. Reinduction treatment will be done in case of progression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 colorectal-cancer
Started Nov 2016
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
First Submitted
Initial submission to the registry
September 8, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedFirst Posted
Study publicly available on registry
November 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2019
CompletedNovember 30, 2016
November 1, 2016
3 years
September 8, 2016
November 29, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
PFS
4-6 months
Secondary Outcomes (2)
OS
22 months
QoL
22 months
Study Arms (2)
Cet maintenance
EXPERIMENTALCetuximab maintenance treatment following induction treatment
Cet+chemo continuation
ACTIVE COMPARATORCetuximab plus continuation mFOLFOX6/FOLFIRI regimens
Interventions
Eligibility Criteria
You may qualify if:
- Histological proof of colorectal cancer (in case of a single metastasis, histological or cytological proof of this lesion should be obtained);
- Distant metastases (patients with only local recurrence are not eligible);
- Unidimensionally measurable disease (\> 1 cm on spiral CT scan or \> 2 cm on chest X-ray; liver ultrasound is not allowed). Serum CEA may not be used as a parameter for disease evaluation;
- In case of previous radiotherapy, at least one measurable lesion should be located outside the irradiated field;
- Ongoing or planned first line treatment with 6 cycles of mFOLFOX6/FOLFIRI plus Cetuximab.
- At randomisation:
- WHO performance status 0-1 (Karnofsky PS \> 70%);
- Laboratory values obtained ≤ 2 weeks prior to randomisation:
- adequate bone marrow function (Hb \> 6.0 mmol/L, absolute neutrophil count \> 1.5 x 109/L, platelets \> 100 x 109/L),
- renal function (serum creatinine ≤ 1.5x ULN and creatinine clearance, Cockroft formula, \> 30 ml/min),
- liver function (serum bilirubin ≤ 2 x ULN, serum transaminases ≤ 3 x ULN without presence of liver metastases or ≤ 5x ULN with presence of liver metastases);
- Negative pregnancy test in women with childbearing potential;
- Expected adequacy of follow-up;
- Institutional Review Board approval;
You may not qualify if:
- History or clinical signs/symptoms of CNS metastases;
- History of a second malignancy ≤ 5 years with the exception of adequately treated carcinoma of cervix or basal/squamous cell carcinoma of skin.
- Prior adjuvant treatment for stage II/III colorectal cancer ending within 6 months before the start of induction treatment;
- Any prior adjuvant treatment after resection of distant metastases;
- Previous systemic treatment for advanced disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ruijin Hospitallead
- Jiangsu Cancer Institute & Hospitalcollaborator
- Henan Cancer Hospitalcollaborator
- Second Affiliated Hospital, School of Medicine, Zhejiang Universitycollaborator
Related Publications (2)
Tveit KM, Guren T, Glimelius B, Pfeiffer P, Sorbye H, Pyrhonen S, Sigurdsson F, Kure E, Ikdahl T, Skovlund E, Fokstuen T, Hansen F, Hofsli E, Birkemeyer E, Johnsson A, Starkhammar H, Yilmaz MK, Keldsen N, Erdal AB, Dajani O, Dahl O, Christoffersen T. Phase III trial of cetuximab with continuous or intermittent fluorouracil, leucovorin, and oxaliplatin (Nordic FLOX) versus FLOX alone in first-line treatment of metastatic colorectal cancer: the NORDIC-VII study. J Clin Oncol. 2012 May 20;30(15):1755-62. doi: 10.1200/JCO.2011.38.0915. Epub 2012 Apr 2.
PMID: 22473155BACKGROUNDVan Cutsem E, Kohne CH, Hitre E, Zaluski J, Chang Chien CR, Makhson A, D'Haens G, Pinter T, Lim R, Bodoky G, Roh JK, Folprecht G, Ruff P, Stroh C, Tejpar S, Schlichting M, Nippgen J, Rougier P. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med. 2009 Apr 2;360(14):1408-17. doi: 10.1056/NEJMoa0805019.
PMID: 19339720BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yifeng Wang, MD
Ruijin Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD &Ph.D
Study Record Dates
First Submitted
September 8, 2016
First Posted
November 30, 2016
Study Start
November 1, 2016
Primary Completion
November 1, 2019
Study Completion
November 1, 2019
Last Updated
November 30, 2016
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will not share