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)

Colorectal Cancer Metastatic Clinical Trial

— ONCOGRAM  

Official title:

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®

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03133273
• Other study ID #: I16014 (ONCOGRAM)
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 24, 2017
• Est. completion date: July 24, 2024

Study information

• Verified date: May 2023
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 256
• Est. completion date: July 24, 2024
• Est. primary completion date: July 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.).

Related Conditions & MeSH terms

• Chemotherapy
• Colorectal Cancer Metastatic
• Colorectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
France	CHU d'AMIENS	Amiens
France	Bergonié Institut	Bordeaux
France	Clinique des Cédres	Brive-la-Gaillarde
France	CHU de TOURS	Chambray-lès-Tours
France	Clermont-Ferrand University Hospital	Clermont-Ferrand
France	CHu de la Martinique	Fort-De-France
France	Hospital Center	Guéret
France	Limoges University Hospital	Limoges
France	Nimes University Hospital	Nîmes
France	CHU de POITIERS	Poitiers
France	CH de Saint Junien	Saint-Junien
France	Centre Médical MGEN Alfred Leune	Sainte-Feyre
France	CHU de Strasbourg	Strasbourg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Limoges	Oncomédics

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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