| Titre |
Comprehensive Molecular Characterization of Advanced Pancreatic Ductal Adenocarcinomas (PDAC) for Better Treatment Selection: A Prospective Study |
| Protocole ID |
COMPASS-001 |
| ClinicalTrials.gov ID |
NCT02750657 |
| Type(s) de cancer |
Pancréas |
| Phase |
Autres |
| Stade |
Adénocarcinomes |
| Type étude |
Génétique |
| Institution |
CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dr Mustapha Tehfé
|
| Coordonnateur(trice) |
Julie Delbos
514-890-8000 poste 25385
|
| Statut |
![]() Fermé |
| Date d'activation |
17-05-2019 |
| Critètes d'éligibilité |
- Patients must have a histological or radiological diagnosis of locally advanced or metastatic pancreatic ductal adenocarcinoma. Patients with borderline resectable disease are not eligible.
- Patient must have a tumor lesion that is amenable to a core needle biopsy.
- Patients must have a measurable lesion by RECIST 1.1 in addition to the lesion that is going to be biopsied.
- Patients must be fit enough to safely undergo a tumor biopsy.
- Age 18 years or older.
- Eastern Cooperative Group (ECOG) performance status of 1 or less.
- Life expectancy of greater than 90 days.
- Patients must have normal organ and marrow function
- Patients must undergo systemic treatment with m-FOLFIRINOX or nab-paclitaxel as a first line standard systemic palliative treatment or combination treatment with m-FOLFIRINOX or nab-paclitaxel with or without other investigational agents within a clinical trial as a first line palliative treatment.
- Ability to understand and willing to sign a written informed consent document.
|
| Critètes d'exclusion |
- Patients with one or more contraindications to tumor biopsy.
- Patients who have prior systemic treatment (chemotherapy or any other anti-cancer agent) in advanced setting.
- Patients who are currently on anti-cancer treatment including chemotherapy.
- Patients with known brain metastases.
- Patients with advanced PDAC who are going to be treated with gemcitabine monotherapy in advanced setting.
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
|
Groupe d'étude en oncologie du Québec