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Prospectively Defining Metastatic Pancreatic Ductal Adenocarcinoma Subtypes by Comprehensive Genomic Analysis

ConditionsCancerPancreatic Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBritish Columbia Cancer Agency

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histological and/or radiological diagnosis of metastatic PDAC. Patients without a histological diagnosis of PDAC must undergo confirmatory tumour biopsy prior to treatment start date.

Planned for first-line systemic therapy with FOLFIRINOX or GP, either in routine care or in combination with an investigational agent(s) within a clinical trial.

Age ≥ 18 years

Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Disqualifiers

Absence of distant or lymph node metastases. Patients with borderline resectable or locally advanced PDAC are not eligible.

Received prior systemic therapy (chemotherapy or any other anti-cancer agent) in the advanced setting. Patients who received adjuvant chemotherapy after surgical resection of early stage disease are eligible.

Currently receiving anti-cancer therapy (chemotherapy or any other anti-cancer agent)

Not fit for combination chemotherapy as judged by the investigator

Trial population

Patients with metastatic PDAC undergoing first-line systemic therapy with either FOLFIRINOX or GP-based regimens.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Tumour Biopsy

    Procedure/Surgery

    If there is the presence of a tumour lesion amenable to core needle biopsy as judged by a staff interventional radiologist, a minimum of 3 tumour cores will be obtained under CT or US guidance.

  • Serial Collection of Plasma and Serum Samples

    Other intervention

    Participants will undergo serial collection of plasma and serum samples at baseline and every cycle of chemotherapy or every 4 weeks, whichever is longer, until end of study.

Treatment groups

190 Participants
are divided into 2 treatment groups
Group A: Biopsy Cohort2 interventions
Group B: Archival Cohort1 intervention

Trial outcomes

Primary outcomes

1

Number of days between biopsy and return of comprehensive genomic results.

The primary endpoint is the assessment of the feasibility of returning comprehensive genomic results within a clinically meaningful timeframe. Specifically the primary endpoint is return of genomic data by 8 weeks from the time of biopsy. This endpoint will be met if the analysis data is available within 8 weeks for 80% of the first 50 patients whose tumours are successfully sequenced.

Time frame
An average of 8 weeks

Secondary outcomes

1

Response Rate

Response rate defined as the percentage of patients with complete (CR) or partial response (PR) per RECIST 1.1

Time frame
Up to an average of 1 year
2

Disease Control Rate

Disease control rate defined as the percentage of patients who experience CR, PR, or stable disease by RECIST 1.1

Time frame
Up to an average of 1 year
3

Duration of Response

Duration of response defined as the interval between the first date of CR or PR and the earliest date of disease progression or death due to any cause

Time frame
Up to an average of 1 year
4

Progression-Free Survival

Progression-free survival (PFS) defined as the interval between the date of registration and the earliest date of disease progression or death due to any cause

Time frame
Up to an average of 1 year

Other outcomes

1

Engraftment rate of patient-derived xenografts

Time frame
5 years
2

Success rate of establishing patient-derived organoids

Time frame
5 years
3

DNA damage repair pathways

Percentage of patients with somatic or germline alterations in DNA damage repair pathways

Time frame
5 years
4

Hypermutated phenotype

Percentage of patients with a hypermutated phenotype

Time frame
5 years

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

Pancreas Centre BC

Collaborator

American Society of Clinical Oncology

Collaborator

Source ClinicalTrials.gov
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