Ignite Creation Date:
2024-05-06 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 12:52 PM
Study NCT ID:
NCT03648632
Status:
COMPLETED
Last Update Posted:
2022-04-20
First Post:
2018-06-20
Brief Title:
Stereotactic Radiotherapy SBRT in Patients With Locally Advanced Pancreatic Cancer LAPC
Sponsor:
Per Pfeiffer
Organization:
Odense University Hospital
Study Overview
Official Title:
Stereotactic Radiotherapy SBRT in Patients With Locally Advanced Pancreatic Cancer LAPC A Danish Phase II Study
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SBRT-PC-01
Brief Summary:
Stereotactic Radiotherapy SBRT in patients with locally advanced pancreatic cancer LAPC
A Danish phase II study
A Danish phase II study
Detailed Description:
Combination chemotherapy eg 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 Simons 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 01 α 01 and a power at 90 β 010 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
The sample size is based on Simons 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 01 α 01 and a power at 90 β 010 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None