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

Official Title

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

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.

Trial Description

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.
Secondary Outcome:
  • Disease control rate achieved by m-FOLFIRINOX
  • Disease control rate achieved by nab-paclitaxel
  • 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
  • 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.
  • 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.
  • 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.
  • Overall survival defined as the interval between the date of registration and the date of death of patients treated with m-FOLFIRINOX
  • Overall survival defined as the interval between the date of registration and the date of death of patients treated with nab-paclitaxel.
  • Correlation between tumour genomic characteristics and m-FOLFIRINOX response using next generation sequencing.
  • Correlation between tumour genomic characteristics and nab-paclitaxel response using the next generation sequencing.
  • 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.
  • Percentage of patients with somatic DSBR deficiency who might benefit from a personalized treatment strategy such as combination of cisplatin and a PARP inhibitor.
  • 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 tumour neo-antigen expression).
  • Percentage of patients with rare but targetable somatic mutations.
  • Difference in disease control rate between patients with tumour smoking signature and those without.
  • Difference in overall survival between patients with tumour smoking signature and those without.
  • Correlation with tumour molecular characteristics and toxicities to treatment using next generation sequencing.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society