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Pancreatic Ductal AdenocarcinomaACCELERATENCT06574620

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

A study testing Genetic testing, Optional biopsy and Tissue collection in people with Pancreatic Ductal Adenocarcinoma and Resectable Pancreatic Ductal Adenocarcinoma, run by British Columbia Cancer Agency at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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?… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Genetic testing, Optional biopsy and Tissue collection
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteCanada
Study dates
28 Nov 2025to Dec 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must meet all of the following criteria prior to Pre-Baseline registration:
  • 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.
  • Participants must meet all of the following criteria to be eligible for enrollment in the Main Study:
Show all 27Show fewer
  • Age 18 years or older.
  • Enrolled in the Personalized Oncogenomics (POG) Program at BC Cancer.
  • Histological and/or radiological diagnosis of resectable, borderline resectable, or locally advanced PDAC. Participants without a histological diagnosis of PDAC must undergo confirmatory histological diagnosis prior to treatment start date.
  • Medically fit to undergo surgical resection of the primary lesion(s) as judged by the investigator (Resectable and Borderline Resectable Cohorts only).
  • Planned for adjuvant (Resectable and Borderline Resectable Cohorts) or first-line (Locally Advanced Cohort) therapy with FOLFIRINOX or a gemcitabine-based regimen, either as part of routine care or in combination with an investigational agent(s) within another clinical trial. Participants may have received pre-operative therapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Adequate organ function as defined by the following laboratory results obtained within 28 days prior to enrollment date:
  • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L.
  • Hemoglobin ≥ 9 g/dL.
  • Platelets ≥ 75 x 10^9/L.
  • Prothrombin time test and international normalized ratio (PT/INR) and partial thromboplastin time (PTT) ≤ 1.5 x Upper Limit of Normal (ULN).
  • Total bilirubin ≤ 1.5 x ULN. Isolated bilirubin > 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%.
  • Aspartate aminotransferase (AST) and alanine aminotransferase (AST) ≤ 1.5 x ULN. If liver metastases are present, AST and ALT ≤ 5 x ULN is permitted.
  • Albumin ≥ 25 g/L.
  • One of the following:
  • Creatinine ≤ 1.5 x ULN.
  • Calculated creatinine clearance (as calculated by Cockcroft-Gault formula) ≥ 40 mL/min.
  • 24-hour urine creatinine clearance ≥ 40 mL/min.
  • Life expectancy greater than 90 days as judged by the investigator.
  • Able to give informed consent for the study procedures defined in this protocol.
  • Measurable disease by RECIST 1.1. For those in the Resectable and Borderline Resectable Cohorts, measurable disease must be present prior to resection surgery.

Who cannot join

  • 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.
  • Positive pregnancy test.
  • Unable to comply with the study assessments and procedures defined in this protocol.
  • Individuals who are otherwise judged by the investigator to be unfit to proceed with this protocol.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Daniel J Renouf, MD contact

800-663-3333

drenouf@bccancer.bc.ca

Canada1 site, 1 recruiting

  • BC Cancer

    Vancouver, British Columbia, V5Z 4E6

    Daniel J Renouf, MD, 800-663-3333, drenouf@bccancer.bc.ca

    Recruiting

Other trials in Canada

About this study

Official title: Accelerating the Actionability of Treatment in Resected and Locally Advanced Pancreatic Cancer

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.
Being tested
Genetic testing, Optional biopsy, Tissue collection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Genetic testingGenetic

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

  • Optional biopsyProcedure or surgery

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

  • Tissue collectionProcedure or surgery

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

Study groups in NCT06574620
Study groupRoleWhat they receive
Resectable CohortOtherParticipants with resectable PDAC. Participants will provide tumour, fluid, and blood samples for genetic testing and other analyses. Tumour samples will be collected from standard resection surgery and optional biopsies. Fluid samples will be collected from a standard laparoscopy procedure. Blood samples will be collected at several timepoints throughout the study. Participants will receive standard chemotherapy (folinic acid (leucovorin), fluorouracil, irinotecan, and oxaliplatin (FOLFIRINOX) or gemcitabine-based) regimens.
Receives: Genetic: Genetic testing; Procedure: Optional biopsy; Procedure: Tissue collection
Borderline Resectable CohortOtherParticipants with borderline resectable PDAC. Participants will provide tumour, fluid, and blood samples for genetic testing and other analyses. Tumour samples will be collected from standard resection surgery and optional biopsies. Fluid samples will be collected from a standard laparoscopy procedure. Blood samples will be collected at several timepoints throughout the study. Participants will receive standard chemotherapy (FOLFIRINOX or gemcitabine-based) regimens.
Receives: Genetic: Genetic testing; Procedure: Optional biopsy; Procedure: Tissue collection
Locally Advanced CohortOtherParticipants with locally advanced PDAC. Participants will provide fluid and blood samples for genetic testing and other analyses. Fluid samples will be collected from a standard laparoscopy procedure. Blood samples will be collected at several timepoints throughout the study. Tumour samples may also be collected, if participants agree to optional biopsies. Participants will receive standard chemotherapy (FOLFIRINOX or gemcitabine-based) regimens.
Receives: Genetic: Genetic testing; Procedure: Optional biopsy; Procedure: Tissue collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (5)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

  5. Overall survival (OS) in each study arm from the initiation of chemotherapy

    The number of days from the initiation of chemotherapy that participants survive in each study arm.

    Measured: From the date of first dose of chemotherapy until the date of death or end of study, whichever comes first, assessed up to 72 months.]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2024
  2. Study start28 Nov 2025
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06574620
Sponsor's protocol ID
H24-01809
Acronym
ACCELERATE
Status last verified
Sep 2026
First submitted
26 Aug 2024
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Strickler JH, Satake H, George TJ, Yaeger R, Hollebecque A, Garrido-Laguna I, Schuler M, Burns TF, Coveler AL, Falchook GS, Vincent M, Sunakawa Y, Dahan L, Bajor D, Rha SY, Lemech C, Juric D, Rehn M, Ngarmchamnanrith G, Jafarinasabian P, Tran Q, Hong DS. Sotorasib in KRAS p.G12C-Mutated Advanced Pancreatic Cancer. N Engl J Med. 2023 Jan 5;388(1):33-43. doi: 10.1056/NEJMoa2208470. Epub 2022 Dec 21.

    PubMed 36546651

  • Wong HL, Zhao EY, Jones MR, Reisle CR, Eirew P, Pleasance E, Grande BM, Karasinska JM, Kalloger SE, Lim HJ, Shen Y, Yip S, Morin RD, Laskin J, Marra MA, Jones SJM, Schrader KA, Schaeffer DF, Renouf DJ. Temporal Dynamics of Genomic Alterations in a BRCA1 Germline-Mutated Pancreatic Cancer With Low Genomic Instability Burden but Exceptional Response to Fluorouracil, Oxaliplatin, Leucovorin, and Irinotecan. JCO Precis Oncol. 2018 Oct 19;2:PO.18.00057. doi: 10.1200/PO.18.00057. eCollection 2018. No abstract available.

    PubMed 32913994

  • O'Kane GM, Grunwald BT, Jang GH, Masoomian M, Picardo S, Grant RC, Denroche RE, Zhang A, Wang Y, Lam B, Krzyzanowski PM, Lungu IM, Bartlett JMS, Peralta M, Vyas F, Khokha R, Biagi J, Chadwick D, Ramotar S, Hutchinson S, Dodd A, Wilson JM, Notta F, Zogopoulos G, Gallinger S, Knox JJ, Fischer SE. GATA6 Expression Distinguishes Classical and Basal-like Subtypes in Advanced Pancreatic Cancer. Clin Cancer Res. 2020 Sep 15;26(18):4901-4910. doi: 10.1158/1078-0432.CCR-19-3724. Epub 2020 Mar 10.

    PubMed 32156747

  • Aung KL, Fischer SE, Denroche RE, Jang GH, Dodd A, Creighton S, Southwood B, Liang SB, Chadwick D, Zhang A, O'Kane GM, Albaba H, Moura S, Grant RC, Miller JK, Mbabaali F, Pasternack D, Lungu IM, Bartlett JMS, Ghai S, Lemire M, Holter S, Connor AA, Moffitt RA, Yeh JJ, Timms L, Krzyzanowski PM, Dhani N, Hedley D, Notta F, Wilson JM, Moore MJ, Gallinger S, Knox JJ. Genomics-Driven Precision Medicine for Advanced Pancreatic Cancer: Early Results from the COMPASS Trial. Clin Cancer Res. 2018 Mar 15;24(6):1344-1354. doi: 10.1158/1078-0432.CCR-17-2994. Epub 2017 Dec 29.

    PubMed 29288237

  • Neoptolemos JP, Palmer DH, Ghaneh P, Psarelli EE, Valle JW, Halloran CM, Faluyi O, O'Reilly DA, Cunningham D, Wadsley J, Darby S, Meyer T, Gillmore R, Anthoney A, Lind P, Glimelius B, Falk S, Izbicki JR, Middleton GW, Cummins S, Ross PJ, Wasan H, McDonald A, Crosby T, Ma YT, Patel K, Sherriff D, Soomal R, Borg D, Sothi S, Hammel P, Hackert T, Jackson R, Buchler MW; European Study Group for Pancreatic Cancer. Comparison of adjuvant gemcitabine and capecitabine with gemcitabine monotherapy in patients with resected pancreatic cancer (ESPAC-4): a multicentre, open-label, randomised, phase 3 trial. Lancet. 2017 Mar 11;389(10073):1011-1024. doi: 10.1016/S0140-6736(16)32409-6. Epub 2017 Jan 25.

    PubMed 28129987

  • Garcea G, Dennison AR, Pattenden CJ, Neal CP, Sutton CD, Berry DP. Survival following curative resection for pancreatic ductal adenocarcinoma. A systematic review of the literature. JOP. 2008 Mar 8;9(2):99-132.

    PubMed 18326920

  • Brenner DR, Poirier A, Woods RR, Ellison LF, Billette JM, Demers AA, Zhang SX, Yao C, Finley C, Fitzgerald N, Saint-Jacques N, Shack L, Turner D, Holmes E; Canadian Cancer Statistics Advisory Committee. Projected estimates of cancer in Canada in 2022. CMAJ. 2022 May 2;194(17):E601-E607. doi: 10.1503/cmaj.212097.

    PubMed 35500919

  • Jones MR, Williamson LM, Topham JT, Lee MKC, Goytain A, Ho J, Denroche RE, Jang G, Pleasance E, Shen Y, Karasinska JM, McGhie JP, Gill S, Lim HJ, Moore MJ, Wong HL, Ng T, Yip S, Zhang W, Sadeghi S, Reisle C, Mungall AJ, Mungall KL, Moore RA, Ma Y, Knox JJ, Gallinger S, Laskin J, Marra MA, Schaeffer DF, Jones SJM, Renouf DJ. NRG1 Gene Fusions Are Recurrent, Clinically Actionable Gene Rearrangements in KRAS Wild-Type Pancreatic Ductal Adenocarcinoma. Clin Cancer Res. 2019 Aug 1;25(15):4674-4681. doi: 10.1158/1078-0432.CCR-19-0191. Epub 2019 May 8.

    PubMed 31068372

  • Aguirre AJ. Oncogenic NRG1 Fusions: A New Hope for Targeted Therapy in Pancreatic Cancer. Clin Cancer Res. 2019 Aug 1;25(15):4589-4591. doi: 10.1158/1078-0432.CCR-19-1280. Epub 2019 Jun 4.

    PubMed 31164372

  • Oettle H, Neuhaus P, Hochhaus A, Hartmann JT, Gellert K, Ridwelski K, Niedergethmann M, Zulke C, Fahlke J, Arning MB, Sinn M, Hinke A, Riess H. Adjuvant chemotherapy with gemcitabine and long-term outcomes among patients with resected pancreatic cancer: the CONKO-001 randomized trial. JAMA. 2013 Oct 9;310(14):1473-81. doi: 10.1001/jama.2013.279201.

    PubMed 24104372

  • Ferrone CR, Pieretti-Vanmarcke R, Bloom JP, Zheng H, Szymonifka J, Wargo JA, Thayer SP, Lauwers GY, Deshpande V, Mino-Kenudson M, Fernandez-del Castillo C, Lillemoe KD, Warshaw AL. Pancreatic ductal adenocarcinoma: long-term survival does not equal cure. Surgery. 2012 Sep;152(3 Suppl 1):S43-9. doi: 10.1016/j.surg.2012.05.020. Epub 2012 Jul 3.

    PubMed 22763261

  • Goldstein D, El-Maraghi RH, Hammel P, Heinemann V, Kunzmann V, Sastre J, Scheithauer W, Siena S, Tabernero J, Teixeira L, Tortora G, Van Laethem JL, Young R, Penenberg DN, Lu B, Romano A, Von Hoff DD. nab-Paclitaxel plus gemcitabine for metastatic pancreatic cancer: long-term survival from a phase III trial. J Natl Cancer Inst. 2015 Jan 31;107(2):dju413. doi: 10.1093/jnci/dju413. Print 2015 Feb.

    PubMed 25638248

  • Canadian Cancer Society's Advisory Committee on Cancer Statistics. Canadian Cancer Statistics 2017: 1-142. Toronto, ON: Canadian Cancer Society; 2017.

  • Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardiere C, Bennouna J, Bachet JB, Khemissa-Akouz F, Pere-Verge D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.

    PubMed 21561347

  • Conroy T, Hammel P, Hebbar M, Ben Abdelghani M, Wei AC, Raoul JL, Chone L, Francois E, Artru P, Biagi JJ, Lecomte T, Assenat E, Faroux R, Ychou M, Volet J, Sauvanet A, Breysacher G, Di Fiore F, Cripps C, Kavan P, Texereau P, Bouhier-Leporrier K, Khemissa-Akouz F, Legoux JL, Juzyna B, Gourgou S, O'Callaghan CJ, Jouffroy-Zeller C, Rat P, Malka D, Castan F, Bachet JB; Canadian Cancer Trials Group and the Unicancer-GI-PRODIGE Group. FOLFIRINOX or Gemcitabine as Adjuvant Therapy for Pancreatic Cancer. N Engl J Med. 2018 Dec 20;379(25):2395-2406. doi: 10.1056/NEJMoa1809775.

    PubMed 30575490

Questions about this trial

What is this clinical trial studying?

A study testing Genetic testing, Optional biopsy and Tissue collection in people with Pancreatic Ductal Adenocarcinoma and Resectable Pancreatic Ductal Adenocarcinoma, run by British Columbia Cancer Agency at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Daniel J Renouf, MD (800-663-3333, drenouf@bccancer.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of comprehensive genomic results returned within 8 weeks of sample collection. (time frame: From the date of resection surgery or baseline ctDNA collection until genomic results are available (typically 8 weeks).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06574620, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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