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. 2021 Aug 21;22(1):556.
doi: 10.1186/s13063-021-05531-y.

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  1   2 , Mathieu Vanderstraete  3 , Christophe Bounaix Morand du Puch  3 , Stéphanie Giraud  3 , Christophe Lautrette  3 , Mehdi Ouaissi  4 , Nicolas Tabchouri  4 , Abdelkader Taïbi  5 , Renaud Martin  6 , Isabelle Herafa  7 , Achille Tchalla  8 , Niki Christou  5   9 ; ONCOGRAM trial investigators
Collaborators, Affiliations

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 et al. Trials. .

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.

Keywords: CSRA; Chemosensitivity; Colorectal cancer; Functional assay; Metastatic; ONCOGRAM; Oncogramme®; Personalized medicine.

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Conflict of interest statement

CL and SG are cofounders of Oncomedics SAS and have equity positions in the company. MV and CMBP are employees of Oncomedics SAS. MM, NC, MO, NT, AT, RM, IH and AT as well as the ONCOGRAM trial investigators declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
ONCOGRAM diagram for confirmed mCRC samples. When mCRC is already histologically diagnosed, inclusion and randomization occur before performing the Oncogramme®. Oncomedics only receives samples and realizes the assays for patients already randomized in the Oncogramme® arm
Fig. 2
Fig. 2
ONCOGRAM diagram for suspected mCRC samples. Oncomedics receives and starts the Oncogramme® procedure on all samples not histologically qualified yet. Randomization occurs if the sample is confirmed as mCRC. Realization of the Oncogramme® is pursued only if the patient is randomized in the Oncogramme® arm. In all other cases, the sample is eliminated
See this image and copyright information in PMC

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