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2024-12-03
2028-12-31
2028-12-31
400
NCT06944587
Oslo University Hospital
Oslo University Hospital
OBSERVATIONAL
A New Clinical Pathway for Personalized Management of Borderline Resectable and Locally Advanced Pancreatic Cancer
NORPACT-3 is a nationwide, Norwegian single arm prospective study that evaluates the resectability rates and survival in patients with borderline resectable and locally advanced pancreatic cancer who received primary chemotherapy. Eligible patients are treated with primary chemotherapy possibly followed by surgical exploration and resection. All Norwegian centres performing pancreatic surgery have agreed to collaborate in this trial. The assignment of the medical intervention is not at the discretion of the investigator, but follow the national Norwegian guidelines regarding diagnostic work up, oncological and surgical treatment and follow up. The primary aim is a national resection rate of 50% in BRPC and 15% in LAPC in patients initiating primary chemotherapy, with adequate overall survival and morbidity/mortality (after resection median overall survival of 24 months, 1 year survival 80%, and 5 year survival >20% + 90 day postoperative mortality ≤5%, 90-day postoperative major morbidity (Clavien Dindo grade 3) ≤40%).
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2025-01-17 | N/A | 2025-04-17 |
2025-04-17 | N/A | 2025-04-25 |
2025-04-25 | N/A | 2025-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Resection rate (of the pancreatic tumour) | Resection rate: National target of 50% in BRPC and 15% in LAPC in patients initiating primary chemotherapy. | From November 2024-December 2027 |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Overall survival | After resection, median overall survival of 24 months, 1 year survival 80%, and 5 year survival >20%. | From November 2024-December 2027 |
| Mortality after surgical resection | 90-day postoperative mortality ≤5% | From November 2024-December 2027 |
| Morbidity after surgical resection | 90-day postoperative major morbidity (Clavien-Dindo ≥ grade3) of ≤40% | From November 2024-December 2027 |
| Number of patients evaluated at national MDT undergoing resection | From November 2024-December 2027 | |
| Adverse events | Adverse events during primary chemotherapy | From November 2023-December 2027 |
| R0 resection rate | R0 (microscopic radical resection >1mm) versus R1 (microscopic residual tumor ≤1mm). | From November 2023-December 2027 |
| Quality of life EORTC QLQ-C30 | Outcome measures will be calculated, according to the validated questionnaire manuals. | Measured at baseline, 3, 6, and 12 months from diagnosis, followed by yearly measurements.] |
| Quality of life EORTC QLQ-PAN26 | Outcome measures will be calculated, according to the validated questionnaire manuals. | Measured at baseline, 3, 6, and 12 months from diagnosis, followed by yearly measurements. |
| Quality of life EQ-5D-5L | Outcome measures will be calculated, according to the validated questionnaire manuals. | Measured at baseline, 3, 6, and 12 months from diagnosis, followed by yearly measurements. |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Knut Jørgen Labori, MD PhD Phone Number: +4723070000 Email: uxknab@ous-hf.no |
Study Contact Backup Name: Jacob Ghotbi, MD Phone Number: +4723070000 Email: Jacob.Ghotbi@ous-hf.no |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
