Metastatic Colorectal Cancer Clinical Trial
— COBRAFOfficial title:
A Study to Collect Patients, Medical, and Biological Data From Patients Being Treated for Metastatic Colorectal Cancer With a Specific Genetic Mutation: BRAFV600E
The study will be conducted in patients with metastatic colorectal cancer (mCRC) harboring a BRAFV600E mutation, to collect clinical data and biological samples to be used for research but also to gather real-world clinical data concerning the treatments and the survival outcomes in patients with this pathology.
Status | Recruiting |
Enrollment | 400 |
Est. completion date | July 2028 |
Est. primary completion date | July 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Men and women aged 18 years or older 2. Histologically confirmed BRAFV600E metastatic colorectal cancer (mCRC), chemotherapy-naive in the metastatic setting or having initiated a first line of chemotherapy in the metastatic setting (except encorafenib-cetuximab treatment) 3. Available tumor tissue sample obtained before inclusion with sufficient tissue left for biological studies. Patients with only fine-needle aspirations are not eligible. 4. Known MMR/microsatellite status (immunohistochemistry [IHC] and polymerase chain reaction [PCR]) (or under analysis) 5. Patients must have signed a written informed consent form prior to any trial specific procedures. If the patients are physically unable to give their written consent, a trusted person of their choice, not related to the investigator or the sponsor, can confirm in writing the patient's consent. 6. Patients must be willing and able to comply with the study procedures 7. The patient must be affiliated to a social security system or benefit of such a system. Exclusion Criteria: 1. Patient with another cancer concomitantly with the mCRC requiring treatment or influencing the prognosis according to the medical staff. 2. Patients for whom the follow-up will not be assured by the investigator or its team. 3. Any condition that may jeopardize patient participation in the study as well as non-contraception for men and women with child-bearing potential, and pregnancy or breast feeding for women. 4. Persons deprived of their liberty or under protective custody or guardianship. |
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier D'Avignon | Avignon | |
France | Centre Hospitalier de Bayeux | Bayeux | |
France | Institut Bergonie | Bordeaux | |
France | Ch de Cahors | Cahors | |
France | Infirmerie Protestante de Lyon | Caluire-et-Cuire | |
France | Chu Estaing de Clermont-Ferrand | Clermont-Ferrand | |
France | Aphp - Hopital Henri Mondor | Créteil | |
France | Groupe Hospitalier Mutualiste de Grenoble | Grenoble | |
France | Chu de Grenoble Alpes - Hopital Michallon | La Tronche | |
France | Groupe Hospitalier Emile Roux | Le Puy-en-Velay | |
France | Hopital Franco-Britannique | Levallois-Perret | |
France | Chu Dupuytren | Limoges | |
France | Centre Leon Berard | Lyon | |
France | Intitut Paoli Calmettes | Marseille | |
France | Grand Hopital de L'Est Francilien - Site de Meaux | Meaux | |
France | Centre Antoine Lacassagne | Nice | |
France | Aphp - Hopital Bichat | Paris | |
France | Aphp - Hopital Saint Louis | Paris | |
France | Aphp - La Pitie Salpetriere | Paris | |
France | Gh Diaconesses Croix Saint Simon | Paris | |
France | Hopital Saint Antoine | Paris | |
France | Institut Mutualiste Montsouris | Paris | |
France | Ch Perpignan | Perpignan | |
France | Chu Poitiers | Poitiers | |
France | Chu de Reims | Reims | |
France | Chu Rennes Pontchaillou | Rennes | |
France | Chu de Rouen | Rouen | |
France | Ch de Saint Malo | Saint-Malo | |
France | ICANS | Strasbourg | |
France | Chu de Tours | Tours | |
France | Chru de Nancy | VandÅ“uvre-lès-Nancy |
Lead Sponsor | Collaborator |
---|---|
UNICANCER | Pierre Fabre Medicament |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Survival (OS) | OS of patients with BRAFV600E mCRC in the real-life setting. The OS is defined as the time between the date of first diagnosis of mCRC and the date of death, whatever the cause. The patients alive at the time of analysis will be censored at the date of their last follow up. | From date of first diagnosis of mCRC and the date of death, whatever the cause, up to 5 years | |
Secondary | Collection of prospective data about BRAFV600E mCRC | Prospective collection of data collected during the normal clinical care. A descriptive analysis of the disease (Patients and tumors characteristics), current medical practices (molecular genotyping in France), and therapeutic sequences and composition of each treatment line (patients treated with immunotherapy, patients enrolled in clinical studies, metastatic surgeries). The resulting qualitative data analysis of the population will be expressed in number with percentage. | Throughout study completion, up to 5 years | |
Secondary | Correlation between prognostic markers and progression-free survival | PFS is defined as the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse. PFS will then be correlated to clinical and biological prognostic markers analyzed at date of first diagnosis of mCRC and date of first progression or death by clinical testing used in routine cancer treatment practice (blood test analysis and tumor sample analysis). The Cox proportional-hazards model will then be used to study potential prognostic parameters PFS. | From date of first diagnosis of mCRC and date of first progression or death, up to 5 years | |
Secondary | Correlation between prognostic markers and overall survival | To identify clinical and biological prognostic markers of OS on blood and tumor samples. the OS is defined as the length of time from first diagnosis of mCRC that patients enrolled in the study are still alive. OS will then be correlated to clinical and biological prognostic markers analyzed at date of first diagnosis of mCRC and date of first progression or death by clinical testing used in routine cancer treatment practice (blood test analysis and tumor sample analysis). The Cox proportional-hazards model will then be used to study potential prognostic parameters OS. | Throughout study completion, up to 5 years | |
Secondary | Objective response rate | The objective response rate (ORR) for each treatment line is defined as the percentage of patients with a complete response (CR) or a partial response (PR) for a given treatment line. | From baseline to first disease progression, up to 5 years | |
Secondary | Disease control rate | The disease control rate (DCR) is defined as the percentage of patients with a CR, a PR or stable disease for a given treatment line. | From baseline to first disease progression, up to 5 years | |
Secondary | Progression-free survival | The progression-free survival (PFS) for each treatment line is defined as the time interval between the start of treatment of the given line and the date of the first disease progression (radiological or clinical) or the start of another anticancer therapy, or death from any cause, whichever occurs first. | From baseline to first disease progression, up to 5 years | |
Secondary | ctDNA kinetics modeling outcome parameters | The detection of ctDNA level assessed by next generation sequencing in the blood of patients with deficient DNA mismatch repair (dMMR) / microsatellite instability (MSI) will be measured at the start of cycle 1, cycle 2, and cycle 3, and at 3 months and 6 months after starting each treatment line, as well as at disease progression.
The level of ctDNA measured at each time point will provide information on how the body interacts with administered treatments overtime. |
From date of first diagnosis of mCRC until the date of first disease progression, up to 5 years | |
Secondary | Correlation between predictive biomarkers and response to treatment | These biomarkers of response/resistance to combination treatment with anti-EGFR/anti-BRAF will be assessed by immunohistochemistry analysis of peripheral blood and tumor tissues. | Throughout study completion, up to 5 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01228734 -
A Trial to Compare Oxaliplatin, Folinic Acid (FA) and 5-Fluorouracil (5FU) Combination Chemotherapy (FOLFOX-4) With or Without Cetuximab in the 1st Line Treatment of Metastatic Colorectal Cancer (mCRC) in Chinese Rat Sarcoma Viral Oncogene Homolog (RAS) Wild-type Patients
|
Phase 3 | |
Completed |
NCT05178745 -
A Prospective Observational Cohort Study Evaluating Resection Rate in Patients With Metastatic Colorectal Cancer Treated With Aflibercept in Combination With FOLFIRI - Observatoire résection
|
||
Completed |
NCT01591421 -
P13Kinase Inhibitor BKM120 in Combination With Panitumumab in Metastatic/Advanced RAS-Wild Type Colorectal Cancer.
|
Phase 1/Phase 2 | |
Withdrawn |
NCT05412706 -
Niraparib Maintenance Treatment in mCRC With a Partial o Complete Response After Oxaliplatin-based Induction Therapy
|
Phase 2 | |
Withdrawn |
NCT04430985 -
FOLFOX + Immunotherapy With Intrahepatic Oxaliplatin for Patients With Metastatic Colorectal Cancer
|
Phase 2 | |
Withdrawn |
NCT03182894 -
Epacadostat in Combination With Pembrolizumab and Azacitidine in Subjects With Metastatic Colorectal Cancer
|
Phase 1/Phase 2 | |
Recruiting |
NCT05725200 -
Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer
|
Phase 2 | |
Terminated |
NCT03176264 -
PDR001 in Combination With Bevacizumab and mFOLFOX6 as First Line Therapy in Patients With Metastatic MSS Colorectal Cancer
|
Phase 1 | |
Completed |
NCT04866290 -
HepaSphereâ„¢ Microspheres Prospective Registry
|
||
Not yet recruiting |
NCT06425133 -
Regorafenib in Combination With Multimodal Metronomic Chemotherapy for Chemo-resistant Metastatic Colorectal Cancers
|
Phase 2 | |
Not yet recruiting |
NCT05531045 -
18FFDG PET/CT for Early Evaluation of Chemotherapy Efficacy in Metastatic Colic Adenocarcinoma
|
||
Withdrawn |
NCT03982173 -
Basket Trial for Combination Therapy With Durvalumab (Anti-PDL1) (MEDI4736) and Tremelimumab (Anti-CTLA4) in Patients With Metastatic Solid Tumors
|
Phase 2 | |
Completed |
NCT02906059 -
Study of Irinotecan and AZD1775, a Selective Wee 1 Inhibitor, in RAS or BRAF Mutated, Second-line Metastatic Colorectal Cancer
|
Phase 1 | |
Active, not recruiting |
NCT02575378 -
Maintenance Treatment With Capecitabine Metronomic Chemotherapy and Chinese Traditional Medicine in Metastatic Colorectal Cancer
|
Phase 4 | |
Withdrawn |
NCT02535988 -
Abscopal Effect for Metastatic Colorectal Cancer
|
Phase 2 | |
Recruiting |
NCT02848807 -
Chemotherapy-related Toxicity, Nutritional Status and Quality of Life
|
N/A | |
Active, not recruiting |
NCT02077868 -
Evaluation of MGN1703 Maintenance Treatment in Patients With mCRC With Tumor Reduction During Induction Treatment
|
Phase 3 | |
Completed |
NCT02414009 -
Study to Compare CAPTEM vs FOLFIRI as Second Line Treatment in Advanced, Colorectal Cancer Patients
|
Phase 2 | |
Active, not recruiting |
NCT01949194 -
Study to Determine the Efficacy of Regorafenib in Metastatic Colorectal Cancer Patients and to Discover Biomarkers
|
Phase 2 | |
Withdrawn |
NCT01915472 -
A Phase II Study of IMMU 130 in Patients With Metastatic Colorectal Cancer
|
Phase 2 |