Evidence map›Paper›PMID 31331370›Full record

Trial reportBMC research notes2019

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

Serge Evrard, Grégoire Desolneux, Carine Bellera, Thomas Esnaud, Yves Bécouarn, Denis Collet, Najim Chafai, Francois Marchal, Laurent Cany, Emilie Lermite and 2 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in BMC research notes, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00766142 (Clinical Phase II Study Evaluating Systemic Chemotherapy in Combination With Cetuximab as Adjuvant Treatment in Patients With Completely Surgically Resected Peritoneal Carcinomatosis of Colorectal Origin), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact, top 87% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00766142 phase2terminatednot on this map

Clinical Phase II Study Evaluating Systemic Chemotherapy in Combination With Cetuximab as Adjuvant Treatment in Patients With Completely Surgically Resected Peritoneal Carcinomatosis of Colorectal Origin

TypeinterventionalSponsorInstitut BergoniéRan2007 to 2013Enrolled18ConditionsColorectal Cancer, Primary Peritoneal Cavity CancerArmscetuximab, fluorouracil, leucovorin calcium, oxaliplatin, adjuvant therapy
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 8 institutions in 1 country.

Serge EvrardDigestive Tumours Unit, Institut Bergonié, Comprehensive Cancer Centre, 229 Cours de l'Argonne, 33076, Bordeaux, France. s.evrard@bordeaux.unicancer.fr.
Grégoire DesolneuxDigestive Tumours Unit, Institut Bergonié, Comprehensive Cancer Centre, 229 Cours de l'Argonne, 33076, Bordeaux, France.
Carine BelleraClinical Research and Clinical Epidemiology Unit (ISO 9001 Certified), Institut Bergonié, Comprehensive Cancer Centre, 229 Cours de l'Argonne, 33076, Bordeaux, France.
Thomas EsnaudClinical Research and Clinical Epidemiology Unit (ISO 9001 Certified), Institut Bergonié, Comprehensive Cancer Centre, 229 Cours de l'Argonne, 33076, Bordeaux, France.
Yves BécouarnDigestive Tumours Unit, Institut Bergonié, Comprehensive Cancer Centre, 229 Cours de l'Argonne, 33076, Bordeaux, France.
Denis ColletDepartment of Visceral Surgery, CHU Bordeaux, Haut Levêque, 33000, Pessac, France.
Najim ChafaiDepartment of Visceral Surgery, Hôpital Saint Antoine, 184 Rue du Faubourg Saint-Antoine, 75012, Paris, France.
Francois MarchalDepartment of Visceral Surgery, CHU Nancy, Rue du Morvan, 54500, Vandœuvre-lès-Nancy, France.
Laurent CanyClinique Francheville, 34 Boulevard de Vesone, 24000, Périgueux, France.
Emilie LermiteDepartment of Visceral Surgery, CHU Angers, 4 Rue Larrey, 49100, Angers, France.
Michel RivoireDepartment of Surgical Oncology, Centre Léon Bérard, Comprehensive Cancer Centre, 28 Promenade Léa et Napoléon Bullukian, 69008, Lyon, France.
Simone Mathoulin-PélissierClinical Research and Clinical Epidemiology Unit (ISO 9001 Certified), Institut Bergonié, Comprehensive Cancer Centre, 229 Cours de l'Argonne, 33076, Bordeaux, France.
Institut Bergonié · FRBordeaux Population Health · FRCentre Hospitalier Régional et Universitaire de Nancy · FRCentre Hospitalier Universitaire d'Angers · FRHôpital Cardiologique du Haut-Lévêque · FRHôpital Saint-Antoine · FRUniversité Claude Bernard Lyon 1 · FRUniversité de Bordeaux · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe 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.

resultsFourteen 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.

Indexed as

AdultAntineoplastic Combined Chemotherapy ProtocolsCetuximabColorectal NeoplasmsCytoreduction Surgical ProceduresFemaleHemorrhageHumansKaplan-Meier EstimateMaleMiddle AgedPeritoneal NeoplasmsProspective StudiesRetrospective StudiesYoung AdultCetuximabColorectal cancerCytoreductive surgeryHyperthermic intraperitoneal chemotherapyKRAS genePeritoneal carcinomatosis

Identifiers

PMID31331370
PMCPMC6647143
OpenAlexW2963226820

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.