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2018-08-22
2022-03-31
2022-03-31
32
NCT03648632
Odense University Hospital
Odense University Hospital
INTERVENTIONAL
Stereotactic Radiotherapy (SBRT) in Patients With Locally Advanced Pancreatic Cancer (LAPC)
Stereotactic Radiotherapy (SBRT) in patients with locally advanced pancreatic cancer (LAPC). A Danish phase II study.
Combination chemotherapy (e.g. FOLFIRINOX (5-fluorouracil, irinotecan, oxaliplatin), Gem-Abraxane, Gem-Cap, Gem-S1) is standard of care in patients with LAPC but more and more scientific studies point to the fact that patients without sign of progressive disease (PD) will benefit from additional radiotherapy and especially SBRT. The sample size is based on Simon's two stages mini-max design. This design ensures early study termination if there is insufficient effect. A resection rate less than 10% after SBRT is not clinically acceptable. Assuming a significance level at 0.1 (α = 0.1) and a power at 90% (β = 0.10) it can be calculated, that 16 patients should be included in the first part of the study. The enrolment will continue until 16 patients have completed SBRT and have been re-evaluated for resection by CT scan (and endoscopic ultrasonography + laparoscopic ultrasound, if available). If 1 or less out of the first 16 consecutive patients are being resected the investigators will reject our hypotheses and close the study after the first stage of accrual. If 2 or more patients are resected, an additional 9 patients will be accrued in the second stage. If at least 4 out of 25 patients are resected, a true resection rate of 30% cannot be excluded, and the investigators will conclude that the treatment is effective enough to continue with future studies. To ensure 25 evaluable patients the investigators will include a total of 30 patients.
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 |
|---|---|---|
2018-06-20 | N/A | 2022-04-19 |
2018-08-24 | N/A | 2022-04-20 |
2018-08-27 | N/A | 2022-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Stereotactic Radiotherapy 50 Gy in 5 fractions within a total of 7 - 8 days | RADIATION: Stereotactic Radiotherapy
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Resection rate for all patients starting SBRT | Resection rate for all patients starting SBRT | 12 month |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 1 year survival for all patients starting SBRT | 1 year survival for all patients starting SBRT | 12 month |
| Progression-free survival (PFS) | PFS will be calculated from the date of registration to the date of documented progressive disease | 12 month |
| Overall survival (OS) | OS will be calculated from the date of registration to the date of documented progressive disease | 12 month |
| Adverse events grade 2-5 (NCI-CTCAE 4.1) | Adverse events grade 2-5 (NCI-CTCAE 4.1) | 12 month |
| Surgical complications, including irreversible electroporation (IRE) (Clavien-Dindo) | Complication rate will be gathered. | 30 days |
| Mortality | Mortality rate | 30 days |
| Mortality | Mortality rate | 90 days |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
