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Using Tumour DNA and Proteins to Better Understand How Pancreatic Cancer Responds to Treatment

ConditionsPancreatic Ductal AdenocarcinomaResectable Pancreatic Ductal AdenocarcinomaBorderline Resectable Pancreatic Ductal AdenocarcinomaLocally Advanced Pancreatic Ductal Adenocarcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBritish Columbia Cancer Agency

About this trial

The goal of this study is to learn if the genetic information and proteins from tumours can help treat pancreatic ductal adenocarcinoma (PDAC). The main questions it aims to answer are:

* Is it feasible to obtain genetic test results within a timeframe that can help inform treatment decisions for individuals with PDAC? * Can the genetic test results provide information about how a tumour will respond to or resist treatment?

Participants will:

* Receive standard chemotherapy to treat their cancer. * Provide samples of their blood, tissue, and fluid for genetic testing. * Visit the clinic every 4 weeks for check-ups and tests. * Complete questionnaires every 12 weeks.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older.

Histological or radiological diagnosis of resectable, borderline resectable, or locally advanced PDAC.

Medically fit and planned to undergo laparoscopic procedure as part of standard of care.

Able to give informed consent for the study-related procedures performed during laparoscopy.

Disqualifiers

Presence of distant or lymph node metastases. Individuals with metastatic PDAC are not eligible.

Currently receiving adjuvant (Resectable and Borderline Resectable Cohorts) or systemic (Locally Advanced Cohort) anti-cancer therapy (chemotherapy or any other anti-cancer agent) with one exception: pre-operative therapy is permitted.

Not fit for chemotherapy as judged by the investigator.

Presence of brain metastases.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Genetic testing

    Genetic

    Analyses of the deoxyribonucleic acid (DNA), ribonucleic acid (RNA), proteins, and other molecules in the sample.

  • Optional biopsy

    Procedure/Surgery

    Optional collection of tumour tissue and normal tissue after the last dose of treatment.

  • Tissue collection

    Procedure/Surgery

    Collection of tumour tissue and normal tissue from biopsy or standard resection surgery prior to the first dose of treatment.

Treatment groups

200 Participants
are divided into 3 treatment groups
Group A: Resectable CohortOther 3 interventions
Group B: Borderline Resectable CohortOther 3 interventions
Group C: Locally Advanced CohortOther 3 interventions

Trial outcomes

Primary outcomes

1

Frequency of comprehensive genomic results returned within 8 weeks of sample collection.

The percentage of participants with comprehensive genomic results for their baseline tumour tissue and/or circulating tumour deoxyribonucleic acid (ctDNA) within 8 weeks of their collection.

Time frame
From the date of resection surgery or baseline ctDNA collection until genomic results are available (typically 8 weeks).

Secondary outcomes

1

Overall response rate (ORR) in each study arm, as defined by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1

The proportion of participants in each study arm who have a complete response (CR) or partial response (PR) to treatment, as defined by RECIST 1.1.

Time frame
From the date of the baseline scan (within 28 days of first dose) until the date of confirmed progression, withdrawal, date of death, or end of study, whichever comes first, assessed up to 72 months.
2

Disease control rate in each study arm, as defined by RECIST 1.1

The proportion of participants in each study arm who have a complete response (CR), partial response (PR), or stable disease (SD) to treatment, as defined by RECIST 1.1.

Time frame
From the date of the baseline scan (within 28 days of first dose) until the date of confirmed progression, withdrawal, date of death, or end of study, whichever comes first, assessed up to 72 months.
3

Duration of response (DoR) in each study arm, as defined by RECIST 1.1

The number of days between the first date of complete response (CR) or partial response (PR) and the earliest date of disease recurrence/progression or death due to any cause.

Time frame
From the first date of CR or PR until the first date of confirmed progression, withdrawal, date of death, or end of study, whichever comes first, assessed up to 72 months.
4

Progression-free survival (PFS) in each study arm from the initiation of chemotherapy

The number of days from the first dose of chemotherapy until the date of progressive disease (PD), as defined by RECIST 1.1, for participants in each study arm.

Time frame
From the date of first dose of chemotherapy until the date of confirmed progression, withdrawal, date of death, or end of study, whichever comes first, assessed up to 72 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

British Columbia Cancer Agency

Lead sponsor

Terry Fox Research Institute

Collaborator

BC Cancer Foundation

Collaborator

Source ClinicalTrials.gov
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