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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
450
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
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
Hôpital Saint Joseph Marseille
Marseille, France
RECRUITINGprogression-free survival
Time frame: 12 months
progression-free survival
Time frame: 24 months
Objective response rates
Sum of complete and partial remission rates measured according to RECIST v1.1
Time frame: 12 months
Objective response rates
Sum of complete and partial remission rates measured according to RECIST v1.1
Time frame: 24 months
Response time
Time from first recognition of response to first recognition of progress
Time frame: 12 months
Rate of treatment change due to tumor progression
Time frame: 2 months
Overall survival
Time frame: 24 months
Diagnostic performance of the Oncogramme device
Calculation of the sensitivity, specificity, and predictive Values of the Oncogramme device
Time frame: 12 months
Budget impact
Calculation of incremental and avoided costs per patient
Time frame: 12 months
Quality of life of patients
measured using EORTC core quality of life questionnaire (QLQ-C30)
Time frame: 12 months
Quality of life of patients
measured using EORTC core quality of life questionnaire (QLQ-C30)
Time frame: 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.