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NCT Number: NCT05132244

Monitoring and Managing Glucose Levels in People With Pancreatic Cancer

This study will investigate whether or not it is feasible to closely monitor and manage glucose levels in people with pancreatic cancer. It will also investigate what impact glucose management may have on pancreatic cancer.

This is a pilot study that will use continuous glucose monitors (CGM) to monitor glucose levels in approximately 50 participants with pancreatic cancer. Participants will receive standard chemotherapy with a combination of up to four drugs to treat their pancreatic cancer: oxaliplatin, irinotecan, 5-fluorouracil, and leucovorin (FOLFIRINOX). To treat high glucose levels, participants will be randomly assigned to one of two groups: Group 1 will receive anti-hyperglycemic treatment as guided by an endocrinologist with the aim of maintaining glucose levels between 4 and 10 mmol/L; Group 2 will receive anti-hyperglycemic treatment if their glucose levels are above 15 mmol/L, which is standard care. Participants in both Groups 1 and 2 will receive standard anti-hyperglycemic treatments: metformin, insulin, glucagon-like peptide-1 (GLP-1) receptor agonists, sodium glucose co-transporter (SGLT2) inhibitors, and dipeptidyl peptidase 4 (DPP-4) inhibitors.

After 4 cycles of FOLFIRINOX, the CGM will be removed but any anti-hyperglycemic treatments will continue as needed. If participants discontinue treatment with FOLFIRINOX, they will continue to be followed for survival and subsequent anti-cancer therapy and will continue follow-up for glucose-related concerns at the discretion of their endocrinologist and/or medical oncologist.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases PDAC - Pancreatic Ductal Adenocarcinoma Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

British Columbia Cancer, Vancouver, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histological/cytological diagnosis of pancreatic ductal adenocarcinoma (PDAC).
  • Planned to undergo first-line systemic therapy with FOLFIRINOX.
  • Age greater than or equal to 18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Adequate bone marrow and organ function as defined by the following laboratory values:
  • Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L.
  • Platelet count greater than or equal to 75 x 10^9/L.
  • Hemoglobin greater than or equal to 9.0 g/dL.
  • Estimated glomerular filtration rate (GFR) by Cockroft-Gault equation OR 24 hour urine collection greater than or equal to 40 ml/min.
  • Creatinine clearance greater than or equal to 40 mL/min using Cockcroft-Gault formula.
  • Potassium within normal limits, or corrected with supplements.
  • International normalized ratio (INR) less than or equal to 1.5.
  • Total serum bilirubin less than or equal to 2 x upper limit of normal (ULN) (any elevated bilirubin should be asymptomatic at enrollment) except for participants with documented Gilbert's syndrome who may only be included if the total bilirubin less than or equal to 3 x ULN or direct bilirubin less than or equal to 1.5 x ULN).
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 2.5 x ULN (or less than or equal to 5 x ULN if liver metastases are present).
  • Able to understand and voluntarily sign the informed consent form.
  • Able to comply with the study visit schedule and other protocol requirements.
  • Able to swallow oral medications and has no contraindications to subcutaneous insulin injections.
  • Measurable or evaluable disease by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 at baseline.
  • Life expectancy of more than 90 days as judged by the study doctor.

Exclusion criteria

  • Absence of distant or lymph node metastases. Participants with borderline resectable or locally advanced PDAC are not eligible.
  • Received prior systemic therapy (chemotherapy or any other anti-cancer agent) for treatment of metastatic PDAC. Participants 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 study doctor.
  • Presence of brain metastases.
  • Known diagnosis of type I diabetes where strict glucose control and close Endocrinology follow-up is already indicated.
  • Known diagnosis of type II diabetes and already followed by Endocrinologist.
  • Female participants with a positive pregnancy test.
  • Participants who are not safe to include in the study as judged by the study doctor for any medical or non-medical reason.
  • Unable to comply with study assessments and follow-up.

Treatment and study plan

Endocrinologist-directed target blood glucose level 4-10 mmol/L using data from a continuous glucose monitor (CGM)

Procedure

Standard anti-hyperglycemic treatment given as directed by an endocrinologist to maintain blood glucose level within 4-10 mmol/L based on data from a continuous glucose monitor (CGM) and standard blood work drawn prior to each cycle of chemotherapy. Participants will have access to their glucose data from the CGM.

Standard care

Other

Standard anti-hyperglycemic treatment given only if blood glucose level is greater than 15 mmol/L as measured from standard blood work drawn prior to each cycle of chemotherapy. Participants will wear a continuous glucose monitor (CGM) but will not have access to their glucose data. Participants may be referred to an endocrinologist at the discretion of their medical oncologist.

Primary outcomes

  1. Frequency of glucose levels maintained within range in Arm 1 compared to Arm 2

    Time frame: From the Cycle 4 FOLFIRINOX treatment date to the Cycle 5 FOLFIRINOX treatment date (each cycle is typically 14 days).

    The percentage of time each participant's glucose levels in Arm 1 and Arm 2 remained within the 4-10 mmol/L range during the fourth cycle of FOLFIRINOX treatment as measured by a continuous glucose monitor.

Secondary outcomes

  1. Overall response rate (ORR) in each study arm, as defined by RECIST 1.1

    Time frame: From the date of the screening 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 43 months.

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

  2. Progression-free survival (PFS) in each study arm from the initiation of FOLFIRINOX

    Time frame: From the date of first dose of FOLFIRINOX until the date of confirmed progression, withdrawal, date of death, or end of study, whichever comes first, assessed up to 43 months.

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

  3. Overall survival (OS) in each study arm from the initiation of FOLFIRINOX

    Time frame: From the date of first dose of FOLFIRINOX until the date of death or end of study, whichever comes first, assessed up to 43 months.

    The length of time from the initiation of FOLFIRINOX that participants survive in each study arm.

Other outcomes

  1. Overall response rate (ORR) in each study arm, as defined by RECIST 1.1 and stratified by prognostic and metabolic gene expression subtypes of PDAC

    Time frame: From the date of the screening 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 43 months.

    The proportion of participants in each study arm stratified by prognostic and metabolic gene expression subtypes of PDAC who have a complete response (CR) or partial response (PR) to FOLFIRINOX treatment, as defined by RECIST 1.1.

  2. Progression-free survival (PFS) in each study arm stratified by prognostic and metabolic gene expression subtypes of PDAC from the initiation of FOLFIRINOX

    Time frame: From the date of first dose of FOLFIRINOX until the date of confirmed progression, withdrawal, date of death, or end of study, whichever comes first, assessed up to 43 months.

    The length of time from the first dose of FOLFIRINOX until the date of progressive disease (PD), as defined by RECIST 1.1, for participants in each study arm stratified by prognostic and metabolic gene expression subtypes of PDAC.

  3. Overall survival (OS) in each study arm stratified by prognostic and metabolic gene expression subtypes of PDAC from the initiation of FOLFIRINOX

    Time frame: From the date of first dose of FOLFIRINOX until the date of death or end of study, whichever comes first, assessed up to 43 months.

    The length of time from the initiation of FOLFIRINOX that participants survive in each study arm stratified by prognostic and metabolic gene expression subtypes of PDAC.

  4. Overall response rate (ORR) in each study arm, as defined by RECIST 1.1 and stratified by clinical features (i.e. type 2 diabetes), pathological profiles, and genomic profiles

    Time frame: From the date of the screening 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 43 months.

    The proportion of participants in each study arm stratified by clinical features (i.e. type 2 diabetes), pathological profiles, and genomic profiles who have a complete response (CR) or partial response (PR) to FOLFIRINOX treatment, as defined by RECIST 1.1.

  5. Progression-free survival (PFS) in each study arm stratified by clinical features (i.e. type 2 diabetes), pathological profiles, and genomic profiles from the initiation of FOLFIRINOX

    Time frame: From the date of first dose of FOLFIRINOX until the date of confirmed progression, withdrawal, date of death, or end of study, whichever comes first, assessed up to 43 months.

    The length of time from the first dose of FOLFIRINOX until the date of progressive disease (PD), as defined by RECIST 1.1, for participants in each study arm stratified by clinical features (i.e. type 2 diabetes), pathological profiles, and genomic profiles.

  6. Overall survival (OS) in each study arm stratified by clinical features (i.e. type 2 diabetes), pathological profiles, and genomic profiles from the initiation of FOLFIRINOX

    Time frame: From the date of first dose of FOLFIRINOX until the date of death or end of study, whichever comes first, assessed up to 43 months.

    The length of time from the initiation of FOLFIRINOX that participants survive in each study arm stratified by clinical features (i.e. type 2 diabetes), pathological profiles, and genomic profiles.

  7. Amount of insulin, measured in molar, for participants in each study arm from screening until the end of study visit

    Time frame: From the date of screening blood sample collection until the date of the end of study blood sample collection (an average of 6 months).

    The quantity of insulin, measured in molar from immunoassays, from blood samples collected throughout the study for the participants in each study arm.

  8. Amount of proinsulin, measured in molar, for participants in each study arm from screening until the end of study visit

    Time frame: From the date of the screening blood sample collection until the date of the end of study blood sample collection (an average of 6 months).

    The quantity of proinsulin, measured in molar from immunoassays, from blood samples collected throughout the study for the participants in each study arm.

  9. Amount of C-peptide, measured in molar, for participants in each study arm from screening until the end of study visit

    Time frame: From the date of the screening blood sample collection until the date of the end of study blood sample collection (an average of 6 months).

    The quantity of C-peptide, measured in molar from immunoassays, from blood samples collected throughout the study for the participants in each study arm.

  10. Amount of circulating biomarkers, measured in molar, for participants in each study arm from screening until the end of study visit

    Time frame: From the date of the screening blood sample collection until the date of the end of study blood sample collection (an average of 6 months).

    The quantity of circulating biomarkers, measured in molar from immunoassays, from blood samples collected throughout the study for the participants in each study arm.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Renouf, MD, MPH

CONTACT

[email protected]

800-663-3333

Sponsors and collaborators

Lead sponsor

British Columbia Cancer Agency

Other

Collaborators

  • Lustgarten Foundation
  • University Health Network, Toronto
  • University of British Columbia

Registry information

Official study title

Pancreatic Cancer Glucose Assessment and Regulation Study

Acronym: PEGASUS

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 24, 2021
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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