Study of the Therapeutic Response and Survival of Patients with Metastatic Colorectal Cancer (stage IV) and Treated According to the Guidelines of a Chemosensitivity Test, Oncogramme® (ONCOGRAM) (ONCOGRAM)

Study of the Therapeutic Response and Survival of Patients with Metastatic Colorectal Cancer (stage IV) and Treated According to the Guidelines of a Chemosensitivity Test, Oncogramme®

Currently, chemotherapies are empirically administered to patients treated for colorectal cancer (CRC). Selection is based on the efficacy of a protocol previously determined on the largest number (consensus treatment), the decision-making process being weighted by patient's intrinsic criteria. However, each patient is unique, due to the inter- and intratumoral heterogeneity inherent in any cancer, partly explaining the unsatisfactory response rates observed for available chemotherapies. Functional sensitivity tests offer the possibility to adapt the treatment to each patient: they are based on an ex vivo study of the responses of the tumor cells (survival / death) to the different molecules / therapeutic combinations (chemotherapy or targeted therapy) likely to be administered to the patient. This response, translated into a tumor-specific sensitivity profile, can be used by the clinicians to determine the most appropriate therapeutic protocol. By increasing the therapeutic efficacy from the first line and reducing the deleterious side effects associated with multiple drug cycles, the sensitivity test transforms the consensus approach into personalized medicine, providing patients with improved progression free survival (PFS) associated with an improvement in the quality of life. Oncomedics has developed Oncogramme®, a CE-labeled in vitro diagnostic medical device that has already demonstrated the ability to predict chemosensitivity in a recent pilot study of metastatic CRC (prediction with 84% chance of success of tumor sensitivity to chemotherapy, vs. 50% maximum for chemotherapy administered according to the consensus method). The hypothesis that patients treated with a metastatic CRC for which systemic chemotherapy is adapted using Oncogramme® have better response rates, PFS and quality of life than patients treated according to usual practice, with optimization of the costs of care. To our knowledge, this is the only fully standardized test available, where each step and reagents of the procedure are mastered. The reliability of the procedure makes it possible to render a personalized result for each patient in 97% of the cases. In addition, the analysis is specifically centered on tumor cells using a method using fully defined, developed and validated media and reagents for each cancer, including CRC. The method of revealing the effect of the therapies identifies the proportion of dead cells in each condition, whatever their physiological state (proliferation / quiescence), by determining the percentage of living and killed cells, thus ensuring high sensitivity

Study Overview

• Status: Completed
• Conditions: Chemotherapy; Colorectal Cancer Metastatic
• Intervention / Treatment: Other: Oncogramme®

• Study Type: Interventional
• Enrollment (Actual): 256
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80054
    • CHU d'AMIENS
  • Bordeaux, France, 33076
    • Bergonié Institut
  • Brive-la-Gaillarde, France, 19100
    • Clinique des Cèdres
  • Chambray-lès-Tours, France, 37170
    • Chu De Tours
  • Clermont-Ferrand, France, 63003
    • Clermont-Ferrand University Hospital
  • Fort-De-France, France, 97261
    • CHU de la Martinique
  • Guéret, France, 23000
    • Hospital Center
  • Limoges, France, 87042
    • Limoges University Hospital
  • Nîmes, France, 30029
    • Nimes University Hospital
  • Poitiers, France, 86021
    • CHU de Poitiers
  • Saint-Junien, France, 87200
    • CH de Saint Junien
  • Sainte-Feyre, France, 23000
    • Centre Médical MGEN Alfred Leune
  • Strasbourg, France, 67000
    • CHU de Strasbourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years
• Patient with metastatic colon or rectal adenocarcinoma (Stage IV) who can benefit from standard systemic chemotherapy (monotherapy based on 5-FU, polychemotherapy type FOLFOX, FOLFIRI, FOLFIRINOX, associated or not with targeted therapies Adapted to the expression of BRAF and RAS, whatever the route of administration of the proposed, oral or intravenous therapies)
• Metastatic CRC diagnosed preoperatively on imaging or per-operative on macroscopic findings and proved by histological analysis (biopsy or surgical excision and if possible biopsies or excrescence on the metastatic sites)
• Measurable metastases according to RECIST
• Chemotherapy for curative or palliative purposes
• Patient with consent.
• Affiliate or beneficiary of a social security scheme.

Exclusion Criteria:

• Formal contraindication to paraclinic exploration essential for patient follow-up
• Exclusive use of radiotherapy, targeted therapy, immunotherapy or hormone therapy, exclusive palliative support
• Patient with an absolute contraindication to the administration of chemotherapy
• Pregnant, lactating or non-contraceptive women for childbearing age women
• Patient with a difficulty of understanding the protocol
• Patient under protective measures (guardianship, curatorship, etc.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care; Patient is followed within the usual care for stage 4 colorectal cancer
Experimental: Oncogramme®; For patients in the Oncogramme® group, chemotherapy will be adapted to Oncogramme® results.	Other: Oncogramme®; Patient is followed within the usual care for stage 4 colorectal cancer, but an Oncogramme test will be made and chemotherapy will be adapted to the results.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of the progression or death of the patient.	The event studied is the occurrence of the progression or death of the patient during the year following the inclusion in the study. The progression of the patient is determined by the RECIST (Response Evaluation Criteria in Solid Tumors).	Year 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response to first-line treatment administrated	Percentage of patients in each response category to first-line treatment administered, evaluated by RECIST in each of the two groups.	every month, up to 12 months
Overall survival	The event study is the death of the patient during the 6 months and the year following the inclusion.	Month 6 and Year 1
Specific survival	The event considered is death due to illness during the 6 months and the year following the inclusion. The attribution of the death to the illness will be made by the adjudication committee.	Month 6 and Year 1
Incremental Cost / Efficiency Ratio	Calculation of the Incremental Cost / Efficiency Ratio (ICER) expressed in euros per year of life gained without occurrence of death or progression to 1 year of the adapted chemotherapeutic treatment according to the results of Oncogramme® using EQ5D-5L s	Year 1
Incremental Cost / Utility Ratio	Calculation of the Incremental Cost / Utility Ratio (ICUR) expressed in euros per QALY gained at 1 year of the adapted chemotherapeutic treatment according to the results of Oncogramme® using EQ5D-5L scale.	Year 1
Quality of life	Compare the quality of life of patients at 3 months, 6 months, 9 months and 1 year between the two groups using the EQ5D-5L questionary score.	Month 3, Month 6, Month 9 and Year 1
No adaptation of chemotherapy	If there is no adaptation of the treatment to the results of Oncogramme®, describe the criteria that led to the failure to take into account the results of Oncogramme®	every month, up to 12 months
Grade 3 and higher adverse events related to chemotherapy	Describe and compare in both groups the proportion of grade 3 and higher adverse events related to chemotherapy.	Year 1

Collaborators and Investigators

• Sponsor: University Hospital, Limoges
• Collaborators: Oncomedics
• Investigators: Principal Investigator: Muriel Mathonnet, MD, University Hospital, Limoges

Publications and helpful links

General Publications

• Mathonnet M, Vanderstraete M, Bounaix Morand du Puch C, Giraud S, Lautrette C, Ouaissi M, Tabchouri N, Taibi A, Martin R, Herafa I, Tchalla A, Christou N; ONCOGRAM trial investigators. 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(R). Trials. 2021 Aug 21;22(1):556. doi: 10.1186/s13063-021-05531-y.

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2017
• Primary Completion (Actual): April 3, 2024
• Study Completion (Actual): April 3, 2024

Study Registration Dates

• First Submitted: April 20, 2017
• First Submitted That Met QC Criteria: April 25, 2017
• First Posted (Actual): April 28, 2017

Study Record Updates

• Last Update Posted (Actual): October 18, 2024
• Last Update Submitted That Met QC Criteria: October 16, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Colorectal Cancer Metastatic; Chemosensitivity
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: I16014 (ONCOGRAM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No