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Glucose Monitoring for Pancreatic Cancer (PEGASUS Trial)

N/A

Recruiting

Led By Erica Tsang, MD, MPH

Research Sponsored by British Columbia Cancer Agency

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Planned to undergo first-line systemic therapy with FOLFIRINOX

Adequate bone marrow and organ function as defined by specific laboratory values

Must not have

Currently receiving anti-cancer therapy

Female participants with a positive pregnancy test

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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.

Awards & highlights

No Placebo-Only Group

Summary

This trial will look at whether closely monitoring and managing glucose levels in people with pancreatic cancer is possible and how it affects the cancer. Around 50 participants with pancreatic cancer will use continuous glucose monitors (CG

Who is the study for?

This trial is for adults over 18 with pancreatic cancer who are about to start their first chemotherapy treatment using FOLFIRINOX. They should be relatively healthy and active (ECOG status 0-1) with certain blood counts and kidney function levels within a specific range.

What is being tested?

The study tests if managing glucose levels between 4-10 mmol/L using continuous monitoring improves outcomes in pancreatic cancer patients, compared to standard care where treatment starts if glucose exceeds 15 mmol/L.

What are the potential side effects?

Possible side effects include those from standard diabetes medications like metformin, insulin, GLP-1 receptor agonists, SGLT2 inhibitors, DPP-4 inhibitors such as low blood sugar, digestive issues or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for my first systemic treatment with FOLFIRINOX.

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My blood tests show my organs and bone marrow are working well.

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I can take pills and have no issues with insulin shots.

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I am 18 years old or older.

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I am fully active or can carry out light work.

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I have been diagnosed with pancreatic cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently undergoing treatment for cancer.

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I am pregnant.

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My cancer has spread to my brain.

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I have had treatment for metastatic pancreatic cancer before.

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My cancer has not spread to distant areas or lymph nodes.

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I have type II diabetes and am under the care of an endocrinologist.

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I have type 1 diabetes and am closely monitored by an endocrinologist.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

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

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

Other study objectives

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

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

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

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Standard CareExperimental Treatment1 Intervention

Participants will receive standard anti-hyperglycemic treatment only if blood glucose level is above 15 mmol/L as measured from standard blood work drawn prior to each cycle of chemotherapy. Participants will wear a CGM but will not be able to view their glucose data. Participants may be referred to an endocrinologist at the discretion of their medical oncologist.

Group II: Intensive Glucose InterventionExperimental Treatment1 Intervention

Participants will receive standard anti-hyperglycemic treatment as guided by an endocrinologist using a combination of data from a continuous glucose monitor (CGM) and standard blood work drawn prior to each cycle of chemotherapy. Treatment will aim to maintain glucose levels between 4 and 10 mmol/L. Participants will have real-time access to their glucose data via the CGM.

0 / 13Eligibility criteria met