Clinical Trial: Study of Changes and Characteristics of Genes in Patients With Pancreatic Cancer for Better Treatment Selection

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Comprehensive Molecular Characterization of Advanced Pancreatic Ductal Adenocarcinomas (PDAC) for Better Treatment Selection: A Prospective Study

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 Summary:
Sponsor: University Health Network, Toronto

Current Primary Outcome: 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. [ Time Frame: 8 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Disease control rate achieved by m-FOLFIRINOX [ Time Frame: 5 years ]
  • Disease control rate achieved by nab-paclitaxel [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 5 years ]
  • Overall survival defined as the interval between the date of registration and the date of death of patients treated with m-FOLFIRINOX [ Time Frame: 5 years ]
  • Overall survival defined as the interval between the date of registration and the date of death of patients treated with nab-paclitaxel. [ Time Frame: 5 years ]
  • Correlation between tumor genomic characteristics and m-FOLFIRINOX response using next generation sequencing. [ Time Frame: 5 years ]
  • Correlation between tumor genomic characteristics and nab-paclitaxel response using the next generation sequencing. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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). [ Time Frame: 5 years ]
  • Percentage of patients with rare but targetable somatic mutations. [ Time Frame: 5 years ]
  • Difference in disease control rate between patients with tumor smoking signature and those without. [ Time Frame: 5 years ]
  • Difference in overall survival between patients with tumor smoking signature and those without. [ Time Frame: 5 years ]
  • Correlation with tumor molecular characteristics and toxicities to treatment using next generation sequencing. [ Time Frame: 5 years ]


Original Secondary Outcome: Same as current

Information By: University Health Network, Toronto

Dates:
Date Received: January 19, 2016
Date Started: February 2016
Date Completion: December 2021
Last Updated: April 20, 2016
Last Verified: April 2016