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| Name | Class |
|---|---|
| University of British Columbia | OTHER |
| Lustgarten Foundation | OTHER |
| University Health Network, Toronto | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive Glucose Intervention | Experimental | 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. |
|
| Standard Care | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of glucose levels maintained within range in Arm 1 compared to Arm 2 | 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. | From the Cycle 4 FOLFIRINOX treatment date to the Cycle 5 FOLFIRINOX treatment date (each cycle is typically 14 days). |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) in each study arm, as defined by RECIST 1.1 | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 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. |
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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel Renouf, MD, MPH | Contact | 800-663-3333 | drenouf@bccancer.bc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Daniel Renouf, MD, MPH | BC Cancer | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| British Columbia Cancer | Recruiting | Vancouver | British Columbia | V5Z 4E6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19485704 | Background | Becker S, Dossus L, Kaaks R. Obesity related hyperinsulinaemia and hyperglycaemia and cancer development. Arch Physiol Biochem. 2009 May;115(2):86-96. doi: 10.1080/13813450902878054. | |
| 23943783 | Background | Dawson DW, Hertzer K, Moro A, Donald G, Chang HH, Go VL, Pandol SJ, Lugea A, Gukovskaya AS, Li G, Hines OJ, Rozengurt E, Eibl G. High-fat, high-calorie diet promotes early pancreatic neoplasia in the conditional KrasG12D mouse model. Cancer Prev Res (Phila). 2013 Oct;6(10):1064-73. doi: 10.1158/1940-6207.CAPR-13-0065. Epub 2013 Aug 13. |
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Participants in Group 1 can view their glucose data in real-time from the continuous glucose monitor (CGM) whereas participants in Group 2 cannot. Participants in Groups 1 and 2 will NOT be masked to the anti-cancer or anti-hyperglycemic treatment they receive.
|
| 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. |
|
| Progression-free survival (PFS) in each study arm from the initiation of FOLFIRINOX | 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. | 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. |
| Overall survival (OS) in each study arm from the initiation of FOLFIRINOX | The length of time from the initiation of FOLFIRINOX that participants survive in each study arm. | 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. |
| Progression-free survival (PFS) in each study arm stratified by prognostic and metabolic gene expression subtypes of PDAC from the initiation of FOLFIRINOX | 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. | 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. |
| Overall survival (OS) in each study arm stratified by prognostic and metabolic gene expression subtypes of PDAC from the initiation of FOLFIRINOX | 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. | 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. |
| 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 | 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. | 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. |
| 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 | 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. | 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. |
| 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 | 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. | 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. |
| Amount of insulin, measured in molar, for participants in each study arm from screening until the end of study visit | The quantity of insulin, measured in molar from immunoassays, from blood samples collected throughout the study for the participants in each study arm. | From the date of screening blood sample collection until the date of the end of study blood sample collection (an average of 6 months). |
| Amount of proinsulin, measured in molar, for participants in each study arm from screening until the end of study visit | The quantity of proinsulin, measured in molar from immunoassays, from blood samples collected throughout the study for the participants in each study arm. | 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). |
| Amount of C-peptide, measured in molar, for participants in each study arm from screening until the end of study visit | The quantity of C-peptide, measured in molar from immunoassays, from blood samples collected throughout the study for the participants in each study arm. | 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). |
| Amount of circulating biomarkers, measured in molar, for participants in each study arm from screening until the end of study visit | The quantity of circulating biomarkers, measured in molar from immunoassays, from blood samples collected throughout the study for the participants in each study arm. | 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). |
| Princess Margaret Cancer Centre | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
|
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
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