ONCOGRAM: study protocol for the evaluation of therapeutic response and survival of metastatic colorectal cancer patients treated according to the guidelines of a chemosensitivity assay, the Oncogramme®

Muriel Mathonnet; Mathieu Vanderstraete; Christophe Bounaix Morand Du Puch; Stéphanie Giraud; Christophe Lautrette; Mehdi Ouaissi; Nicolas Tabchouri; Abdelkader Taïbi; Renaud Martin; Isabelle Herafa; Achille Tchalla; Niki Christou; B. Marin; S. Bouvier; S. Durand-Fontanier; A. Fabre; D. Valleix; T. Rivaille; F. Fredon; S. Derbal; P. Carrier; R. Daloko Lonfo; R. Legros; S. Lavau-Denes; V. Lebrun-Ly; F. Thuillier; P. Engel; A. Chaunavel; M. Pradel; D. Pezet; A. Dubois; C. Pétorin; O. Antomarchi; A. Aboukassem; A. Vimal-Baguet; B. Gillet; B. Mathieu; J. Joubert-Zakeyh; S. Evrard; Y. Becouarn; D. Béchade; M. Fonk; G. Desolneux; N. Dauriat; M. Agbo; M. Louty; F. Borie; S. Lyubimova; V. Phoutthasang; B. Brunaud-Gagniard; Y. Benadjaoud; N. Rolland; L. Letournoux; P. Roger; L. Chen; Z. Amadou; C. Christopoulous; G. Nakahl; Y. Souliman; M. Cirt; D. Ducoux; P. Boisseau; P. Pardies; L. Mesturoux; L. Vayre; A. Abdeh; F. Teboul; R. Landraud; Mehdi Ouaissi; E. Salamé; Nicolas Tabchouri; T. Lecomte; G. Proutheau; S. Guyetant; D. Tougeron; A. de Singly; A. Ferru; R. El Fadel; T. Courvoisier; A. Junca; E. Frouin; L. Rouleau; S. Rafaert; A. Rocher; J-M Regimbeau; C. Sabbagh; E. Dumange; E. Chive; D. Lignier; N. Siembida; B. Chauffert; V. Hautefeuille; D. Chatelain; E. Rivkine

doi:10.1186/s13063-021-05531-y

Journal Articles Trials Year : 2021

ONCOGRAM: study protocol for the evaluation of therapeutic response and survival of metastatic colorectal cancer patients treated according to the guidelines of a chemosensitivity assay, the Oncogramme®

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Muriel Mathonnet

Function : Author
PersonId : 779522
ORCID : 0000-0002-9127-3068
IdRef : 124951414

Fédération de chirurgie viscérale et digestive

Mathieu Vanderstraete

Function : Author

Centre d’Infection et d’Immunité de Lille - INSERM U 1019 - UMR 9017 - UMR 8204

Christophe Bounaix Morand Du Puch

Function : Author

ONCOMEDICS SAS

Stéphanie Giraud

Function : Author

Laboratoire d'Anthropologie et de Psychologie Cliniques, Cognitives et Sociales

Christophe Lautrette

Function : Author

ONCOMEDICS SAS

Mehdi Ouaissi

Function : Author

CHU Trousseau [Tours]

Nicolas Tabchouri

Function : Author

Hôpital Trousseau

Abdelkader Taïbi

Function : Author

CHU Limoges

XLIM

Renaud Martin

Function : Author

Isabelle Herafa

Function : Author

Achille Tchalla

Function : Author

Handicap, Activité, Vieillissement, Autonomie, Environnement

CHU Limoges

Niki Christou

Function : Author

Contrôle de l’Activation Cellulaire, Progression Tumorale et Résistance thérapeutique

Service de Chirurgie digestive, endocrinienne et générale [CHU Limoges]

B. Marin

Function : Author

Groupe d'Étude sur les Géomatériaux et Environnements Naturels, Anthropiques et Archéologiques - EA 3795

S. Bouvier

Function : Author

S. Durand-Fontanier

Function : Author

Service de Chirurgie digestive, endocrinienne et générale [CHU Limoges]

XLIM

A. Fabre

Function : Author

Commissariat à l'énergie atomique et aux énergies alternatives

D. Valleix

Function : Author

Service de Chirurgie digestive, endocrinienne et générale [CHU Limoges]

T. Rivaille

Function : Author

F. Fredon

Function : Author

S. Derbal

Function : Author

P. Carrier

Function : Author

R. Daloko Lonfo

Function : Author

R. Legros

Function : Author

Groupe d'étude des semiconducteurs

S. Lavau-Denes

Function : Author

Service d'Oncologie médicale [CHU Limoges]

V. Lebrun-Ly

Function : Author

Hôpital Dupuytren [CHU Limoges]

F. Thuillier

Function : Author

P. Engel

Function : Author

A. Chaunavel

Function : Author

M. Pradel

Function : Author

D. Pezet

Function : Author

CHU Clermont-Ferrand

Université Clermont Auvergne

A. Dubois

Function : Author

Laboratoire de Chimie Physique - Matière et Rayonnement

C. Pétorin

Function : Author

CHU Clermont-Ferrand

O. Antomarchi

Function : Author

A. Aboukassem

Function : Author

A. Vimal-Baguet

Function : Author

B. Gillet

Function : Author

Institut de Chimie des Substances Naturelles

B. Mathieu

Function : Author

Institut de Parasitologie et de Pathologie Tropicale

J. Joubert-Zakeyh

Function : Author

Service d'Anatomie et de Cytologie Pathologiques

Neuro-Dol

S. Evrard

Function : Author

Centre de Référence des Mastocytoses de Toulouse

Université Toulouse III - Paul Sabatier

Y. Becouarn

Function : Author

Institut Bergonié [Bordeaux]

D. Béchade

Function : Author

M. Fonk

Function : Author

G. Desolneux

Function : Author

N. Dauriat

Function : Author

M. Agbo

Function : Author

M. Louty

Function : Author

F. Borie

Function : Author

Hôpital Universitaire Carémeau [Nîmes]

S. Lyubimova

Function : Author

CHU Montpellier = Montpellier University Hospital

V. Phoutthasang

Function : Author

B. Brunaud-Gagniard

Function : Author

Y. Benadjaoud

Function : Author
PersonId : 1419828
IdRef : 230079768

N. Rolland

Function : Author

L. Letournoux

Function : Author

P. Roger

Function : Author

L. Chen

Function : Author

Z. Amadou

Function : Author

C. Christopoulous

Function : Author

G. Nakahl

Function : Author

Y. Souliman

Function : Author

M. Cirt

Function : Author

D. Ducoux

Function : Author

P. Boisseau

Function : Author

P. Pardies

Function : Author

L. Mesturoux

Function : Author

L. Vayre

Function : Author

A. Abdeh

Function : Author

F. Teboul

Function : Author

R. Landraud

Function : Author

Mehdi Ouaissi

Function : Author

CHU Trousseau [Tours]

E. Salamé

Function : Author

Nicolas Tabchouri

Function : Author

Hôpital Trousseau

T. Lecomte

Function : Author

G. Proutheau

Function : Author

S. Guyetant

Function : Author

D. Tougeron

Function : Author

A. de Singly

Function : Author

A. Ferru

Function : Author

R. El Fadel

Function : Author

T. Courvoisier

Function : Author

A. Junca

Function : Author

E. Frouin

Function : Author

L. Rouleau

Function : Author

S. Rafaert

Function : Author

A. Rocher

Function : Author

J-M Regimbeau

Function : Author

C. Sabbagh

Function : Author
PersonId : 1151816
ORCID : 0000-0001-7525-0627
IdRef : 154808261

E. Dumange

Function : Author

E. Chive

Function : Author

D. Lignier

Function : Author

N. Siembida

Function : Author

B. Chauffert

Function : Author
PersonId : 919116
ORCID : 0000-0001-7533-5401
IdRef : 067133428

V. Hautefeuille

Function : Author

D. Chatelain

Function : Author
PersonId : 1149906
IdRef : 080482635

E. Rivkine

Function : Author

Abstract

Abstract Background Colorectal cancer is a major public concern, being the second deadliest cancer in the world. Whereas survival is high for localized forms, metastatic colorectal cancer has showed poor prognosis, with a 5-year survival barely surpassing 11%. Conventional chemotherapies against this disease proved their efficiency and remain essential in first-line treatment. However, the large number of authorized protocols complexifies treatment decision. In common practice, such decision is made on an empirical basis, by assessing benefits and risks for the patient. In other words, there is currently no efficient means of predicting the efficacy of any chemotherapy protocol for metastatic colorectal cancer. Methods/design The use of a chemosensitivity assay, the Oncogramme®, should help clinicians administer the best chemotherapy regimen to their patients. We hypothesize it would ultimately improve their survival. In this multicentred, prospective trial (ONCOGRAM), eligible patients with metastatic colorectal cancer are randomized to determine whether they will receive an Oncogramme®. For clinicians whose patients benefited from the assay (arm A), results are used as a decision support tool. Patients not undergoing the Oncogramme® procedure are treated according to current practice, without the assistance of the assay (arm B). Primary outcome is 1-year progression-free survival. Secondary outcomes include response rates, as well as 6-month and 1-year survival rates. Discussion This study aims at investigating the clinical utility of the Oncogramme® as a decision support tool for the treatment of patients with metastatic colorectal cancer. If the Oncogramme® positively influenced patient overall survival and/or progression-free survival, it would be of great value for clinicians to implement this assay within the current landscape of personalized medicine tools, which include genomics and biomarker assays. Trial registration ClinicalTrials.gov identifier NCT03133273 . Registered on April 28, 2017.

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https://hal.science/hal-04491661

Submitted on : Wednesday, March 6, 2024-10:24:42 AM

Last modification on : Thursday, December 19, 2024-11:12:04 AM

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hal-04491661 , version 1 (06-03-2024)

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HAL Id : hal-04491661 , version 1
DOI : 10.1186/s13063-021-05531-y

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Muriel Mathonnet, Mathieu Vanderstraete, Christophe Bounaix Morand Du Puch, Stéphanie Giraud, Christophe Lautrette, et al.. ONCOGRAM: study protocol for the evaluation of therapeutic response and survival of metastatic colorectal cancer patients treated according to the guidelines of a chemosensitivity assay, the Oncogramme®. Trials, 2021, 22 (1), pp.556. ⟨10.1186/s13063-021-05531-y⟩. ⟨hal-04491661⟩

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ONCOGRAM: study protocol for the evaluation of therapeutic response and survival of metastatic colorectal cancer patients treated according to the guidelines of a chemosensitivity assay, the Oncogramme®

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