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)

NCT03133273 | Completed

• 1 other identifier: I16014 (ONCOGRAM)
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 13

Brief Summary

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

Conditions

Colorectal Cancer Metastatic; Chemotherapy

Keywords

Colorectal Cancer Metastatic; Chemosensitivity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Response to first-line treatment administrated

  every month, up to 12 months

• Overall survival

  Month 6 and Year 1

• Specific survival

  Month 6 and Year 1

• Incremental Cost / Efficiency Ratio

  Year 1

• Incremental Cost / Utility Ratio

  Year 1

Study Arms (2)

Usual care

NO INTERVENTION

Patient is followed within the usual care for stage 4 colorectal cancer

Oncogramme®

EXPERIMENTAL

For patients in the Oncogramme® group, chemotherapy will be adapted to Oncogramme® results.

Other: Oncogramme®

Interventions

Oncogramme® OTHER

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.

Oncogramme®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• University Hospital, Limoges: lead
• Oncomédics: collaborator

Study Sites (13)

CHU d'AMIENS

Amiens, 80054, France

Location

Bergonié Institut

Bordeaux, 33076, France

Location

Clinique des Cédres

Brive-la-Gaillarde, 19100, France

Location

CHU de TOURS

Chambray-lès-Tours, 37170, France

Location

Clermont-Ferrand University Hospital

Clermont-Ferrand, 63003, France

Location

CHu de la Martinique

Fort-De-France, 97261, France

Location

Hospital Center

Guéret, 23000, France

Location

Limoges University Hospital

Limoges, 87042, France

Location

Nimes University Hospital

Nîmes, 30029, France

Location

CHU de POITIERS

Poitiers, 86021, France

Location

CH de Saint Junien

Saint-Junien, 87200, France

Location

Centre Médical MGEN Alfred Leune

Sainte-Feyre, 23000, France

Location

CHU de Strasbourg

Strasbourg, 67000, France

Location

Related Publications (1)

• 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.

  PMID: 34419125 DERIVED

Study Officials

• Muriel Mathonnet, MD

  University Hospital, Limoges

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The result of Oncogramme® will not give to the patient.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients corresponding to the inclusion criteria and having a histologically proven metastatic CRC on biopsies or primary tumor excision and / or one or more metastatic sites will be recruited prospectively and randomized into two groups. 1. Usual care group: no Oncogramme will be made. 2. Oncogramme group: Taking of tumor fragments on the histological piece by an anatomopathological physician at the time of the histological examination and placing samples in the transport medium. The Oncogramme will be performed by Oncomedics on all specimens. Results will be returned to clinicians within 15 days. For both groups, the adjuvant treatment will be decided in the multidisciplinary consultation meeting (MCM), according to the recommendations in force and adapted to the general medical condition of the patient. For patients in the Oncogramme group, chemotherapy will be adapted to Oncogramme.

Study Record Dates

• First Submitted: April 20, 2017
• First Posted: April 28, 2017
• Study Start: July 24, 2017
• Primary Completion: April 3, 2024
• Study Completion: April 3, 2024
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (13)