Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
500 participants
INTERVENTIONAL
2016-11-30
2019-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cet maintenance
Cetuximab maintenance treatment following induction treatment
Cetuximab
anti-EGFR monoclonal antibody
Cet+chemo continuation
Cetuximab plus continuation mFOLFOX6/FOLFIRI regimens
Cetuximab
anti-EGFR monoclonal antibody
mFOLFOX6
Oxaliplatin+LV5FU2
FOLFIRI
Irinotecan+LV5FU2
Interventions
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Cetuximab
anti-EGFR monoclonal antibody
mFOLFOX6
Oxaliplatin+LV5FU2
FOLFIRI
Irinotecan+LV5FU2
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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;
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
Yes
Sponsors
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Jiangsu Cancer Institute & Hospital
OTHER
Henan Cancer Hospital
OTHER_GOV
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Ruijin Hospital
OTHER
Responsible Party
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Hao Li
MD &Ph.D
Principal Investigators
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Yifeng Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Ruijin Hospital
Central Contacts
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References
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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.
Van 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.
Other Identifiers
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RJH-Cet-Maintenance
Identifier Type: -
Identifier Source: org_study_id