Study of Changes and Characteristics of Genes in Patients With Pancreatic Cancer for Better Treatment Selection
Active, not recruiting
- Conditions
- Carcinoma, Pancreatic Ductal
- Interventions
- Genetic: Molecular Profiling
- Registration Number
- NCT02750657
- Lead Sponsor
- University Health Network, Toronto
- Brief Summary
Researchers are looking for better ways of understanding and treating pancreatic cancer. The purpose of this study is to see how useful it is to look for changes and characteristics in your genes (molecules that contain instructions for the development and functioning of the cells) and the genes within the tumour. These characteristics may be useful in choosing treatments for patients in the future. Changes (mutations) in genes have been shown to be an important characteristic in cancers. Looking at differences in genes in patients with advanced pancreatic ductal adenocarcinomas and comparing this information with response to their initial chemotherapy treatment may help to learn which treatments may be better for certain patients after initial treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 332
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with advanced pancreatic ductal adenocarcinoma Molecular Profiling -
- Primary Outcome Measures
Name Time Method The feasibility of prospectively identifying subgroups of patients with advanced PDAC who have distinct genomic characteristics for better treatment selection while undergoing 1st-line chemotherapy using next generation sequencing. 8 weeks
- Secondary Outcome Measures
Name Time Method Disease control rate achieved by m-FOLFIRINOX 5 years Duration of response defined as the interval between the first date of complete response or partial response and the earliest date of disease progression or death due to any cause to m-FOLFIRINOX 5 years Duration of response defined as the interval between the first date of complete response or partial response and the earliest date of disease progression or death due to any cause to nab-paclitaxel. 5 years Progression free survival defined as the interval between the date of registration and the earliest date of disease progression or death due to any cause of patients treated with m-FOLFIRINOX. 5 years Disease control rate achieved by nab-paclitaxel 5 years Correlation with tumor molecular characteristics and toxicities to treatment using next generation sequencing. 5 years Progression free survival defined as the interval between the date of registration and the earliest date of disease progression or death due to any cause of patients treated with nab-paclitaxel. 5 years Overall survival defined as the interval between the date of registration and the date of death of patients treated with nab-paclitaxel. 5 years Percentage of patients who might benefit from immunotherapy (patients with smoking genomic signatures, patients with a hypermutated phenotype, patients with mismatch repair deficiency and patients with tumor neo-antigen expression). 5 years Difference in disease control rate between patients with tumor smoking signature and those without. 5 years Difference in overall survival between patients with tumor smoking signature and those without. 5 years Correlation between tumor genomic characteristics and nab-paclitaxel response using the next generation sequencing. 5 years Overall survival defined as the interval between the date of registration and the date of death of patients treated with m-FOLFIRINOX 5 years Correlation between tumor genomic characteristics and m-FOLFIRINOX response using next generation sequencing. 5 years Percentage of patients with germline BRCA, PALB2 and ATM mutations who might benefit from a personalized treatment strategy such as combination of cisplatin and a PARP inhibition. 5 years Percentage of patients with somatic DSBR deficiency who might benefit from a personalized treatment strategy such as combination of cisplatin and a PARP inhibitor. 5 years Percentage of patients with rare but targetable somatic mutations. 5 years
Trial Locations
- Locations (4)
Kingston Health Sciences Centre
🇨🇦Kingston, Ontario, Canada
McGill University Health Centre
🇨🇦Montréal, Quebec, Canada
Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
🇨🇦Montréal, Quebec, Canada