Impact of Using the Oncogramme® Device to Select the First Line of Treatment (Chemotherapies +/- Targeted Therapies) for Patients With Metastatic Colorectal Cancer on Progression-free Survival, Treatment Costs, Efficiency and Quality of Life Compared to Usual Patient Care.

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Colorectal cancer is the 2nd leading cause of cancer death in France. Its incidence is nearly 45,000 new cases per year in 2017, with an estimated 5-year survival of 63% in 2015. Metastases are seen in 40-60% of colorectal cancer cases. The 5-year survival rate ranges from 5% to 15% for patients with widespread metastatic disease. Two types of treatments are used to treat colon cancer: surgery and medication protocol (chemotherapeutic drugs and targeted therapies). These treatments can be used alone or in combination. The current choice of a first line of chemotherapy is left to the practitioner's discretion, after consultation with a multidisciplinary consultation meeting. The choice of treatment(s) depends on official recommendations and is based on the results of clinical trials conducted on large populations, and takes into account the toxicities of the therapies used and the general condition of the patients. The therapeutic combinations for colorectal cancers are therefore multiple. However, to date, no consensus has been reached to ensure that each patient is treated effectively and as a unique case. Today, functional sensitivity tests offer the possibility for patients to be offered a personalized treatment against cancer. This is the case of the Oncogramme® device developed by Oncomedics, which is the first functional sensitivity test dedicated to oncology in Europe. It is based on an in vitro analysis of each patient's tumor cells in order to compare the responses of the tumor cells to the different molecules and therapeutic combinations available (chemotherapy ± targeted therapy). This response, translated into a tumor-specific sensitivity profile, can be used by the medical team to determine the most appropriate treatment for the patient. This test is therefore likely to improve the benefit-risk ratio of a chemotherapy treatment in colorectal cancer by allowing the medical team to select, among the treatments deemed effective, the one that will be the most effective on the tumor and possibly with the least side effects. The hypothesis of this study is that the personalization of treatments (by chemotherapy associated or not with targeted therapies) proposed by the Oncogramme®-colorectal device would allow to promote the best possible clinical response, to limit the side effects and ultimately to improve the survival and the quality of life of the patient.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 18 years old and older

• Patient with suspected mCRC (synchronous or metachronous metastases (only if biopsy is required as part of routine care))

• Patient eligible for standard systemic chemotherapy (multidrug therapy such as FOLFOX, FOLFIRI, FOLFIRINOX, combined or not with anti- EGFR or anti-VEGF targeted therapies adapted to BRAF and RAS expression)

• colorectal adenocarcinoma histologically proven

• At least one measurable metastasis according to RECIST v1.1

• Chemotherapy for curative or palliative purposes

• Oncograms® can be performed

• WHO score ≤ 2

• Life expectancy \> 3 months

• neutrophils \> 1500/mm3, platelets \> 100 000/mm3, Hb \> 9 g/dL

• Total bilirubin \< 25 μmol/L, aspartate aminotransferase \< 5 ULN (upper limits of normal), alanine aminotransferase \< 5 ULN, alkaline phosphatase \< 5 ULN, prothrombin rate \> 60%, proteinuria \< 1 g/24h

• No prior chemotherapy except peri-operative or adjuvant chemotherapy stopped more than 6 months ago

• Creatinine clearance \> 50 mL/min according to MDRD formula

• Patient affiliated to a social security scheme

• Information to the patient and signature of the informed consent form.

Locations
Other Locations
France
Hôpital Saint Joseph Marseille
RECRUITING
Marseille
Contact Information
Primary
Christophe Lautrette, PhD
c.lautrette@oncomedics.com
0033 5 55 33 85 25
Backup
Stéphanie Giraud, PhD
s.giraud@oncomedics.com
0033 5 55 33 85 25
Time Frame
Start Date: 2023-06-07
Estimated Completion Date: 2028-12
Participants
Target number of participants: 450
Treatments
Experimental: Oncogramme group
The oncologist has access to the results of the Oncogramme® Device and decides on the treatment according to the recommendations of the Oncogramme® Device
Other: Control group
The oncologist does not have access to the results of the Oncogramme® Device and decides on the treatment according to the standard of care.
Related Therapeutic Areas
Sponsors
Collaborators: Hospital St. Joseph, Marseille, France
Leads: Oncomedics

This content was sourced from clinicaltrials.gov

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