Systemic chemotherapy plus cetuximab after complete surgery in the treatment of isolated colorectal peritoneal carcinoma: COCHISE phase II clinical trial

Autor: Thomas Esnaud, Emilie Lermite, Francois Marchal, Simone Mathoulin-Pélissier, Carine Bellera, Denis Collet, Yves Becouarn, M. Rivoire, Gregoire Desolneux, L. Cany, Serge Evrard, Najim Chafai
Rok vydání: 2019
Předmět:
0301 basic medicine
Oncology
Male
Colorectal cancer
Phases of clinical research
lcsh:Medicine
Cetuximab
Kaplan-Meier Estimate
medicine.disease_cause
0302 clinical medicine
FOLFOX
Antineoplastic Combined Chemotherapy Protocols
Cytoreductive surgery
030212 general & internal medicine
Prospective Studies
lcsh:QH301-705.5
Peritoneal Neoplasms
education.field_of_study
General Medicine
Cytoreduction Surgical Procedures
Middle Aged
Research Note
Hyperthermic intraperitoneal chemotherapy
Female
KRAS gene
KRAS
Colorectal Neoplasms
medicine.drug
Adult
medicine.medical_specialty
Population
Hemorrhage
General Biochemistry
Genetics and Molecular Biology
03 medical and health sciences
Young Adult
Internal medicine
medicine
Humans
education
lcsh:Science (General)
Retrospective Studies
business.industry
lcsh:R
medicine.disease
Clinical trial
030104 developmental biology
lcsh:Biology (General)
business
Peritoneal carcinomatosis
lcsh:Q1-390
Zdroj: BMC Research Notes
BMC Research Notes, Vol 12, Iss 1, Pp 1-6 (2019)
ISSN: 1756-0500
Popis: Objective The primary objective of this non-randomised phase II study was to evaluate the combination of systemic chemotherapy plus cetuximab after complete cytoreductive surgery (CCS) for treatment of isolated colorectal peritoneal carcinoma (CRPC). This multicentre, prospective phase II clinical trial was conducted in seven national cancer referral centres, however research published during study recruitment indicated cetuximab treatment as ineffective in patients with mutated KRAS genes, leading to an additional exclusion criterion to the current protocol, excluding patients with mutated KRAS genes. This significantly impacted recruitment and the study did not achieve the necessary recruitment of 46 patients. Results Fourteen patients underwent CCS and were included in the study, however one did not provide informed consent and another received only one cycle of chemotherapy leading to 12 patients in the per protocol population for analysis. Adjuvant Folfox Cetuximab was administered when CCS was achieved for patients > 18 years with histologically proven CRPC and no other metastatic disease (liver, lungs, lymphadenopathy, etc.). CRPC median index was 5.00 (range: 1–17). Median PFS was 12.3 months [95% CI (3.7–28.2)] with 8.3% [95% CI (0.5–31.1)] and 0% PFS at 3 and 5 years respectively. Median OS was 43.4 months [95% CI (16.8–60)]. Trial registration Clinical Trials NCT00766142, October 3, 2008. Retrospectively registered
Databáze: OpenAIRE
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