Stereotactic Radiotherapy (SBRT) in Patients With Locally Advanced Pancreatic Cancer (LAPC)

Study Overview
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Brief Summary
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Stereotactic Radiotherapy (SBRT) in patients with locally advanced pancreatic cancer (LAPC). A Danish phase II study.

Detailed Description
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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.

Official Title
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Stereotactic Radiotherapy (SBRT) in Patients With Locally Advanced Pancreatic Cancer (LAPC). A Danish Phase II Study

Conditions
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Locally Advanced Pancreatic Cancer

Intervention / Treatment
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* Radiation: Stereotactic Radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: LAPC (Karolinska Type B, C or D1) Cytologically or histologically verified adenocarcinoma/carcinoma Prior combination chemotherapy for 2-6 months (unless contraindicated) and no sign of progressive disease The patient is medically operable (i.e. no co-morbidity which can preclude anaesthesia or surgery) World Health Organization performance status 0-1 Age ≥ 18 years Adequate hepatic function: bilirubin <3.0 x Upper Normal Limit, International Normalized Ratio <1.6, Activated Partial Thromboplastin Time < 1,5 x Upper Normal Limit. Patients with obstruction of bile duct or gut must be drained before start of therapy Oral and written informed consent must be obtained prior to registration with planned date of first treatment within 14 days from registration. Exclusion Criteria: M1 disease Prior radiotherapy to abdominal cavity Pregnancy or breast-feeding. Fertile patients must use adequate contraceptives Severe uncontrolled concomitant illness (e.g. clinically significant cardiac disease or myocardial infarction within 12 months)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stereotactic Radiotherapy<br>50 Gy in 5 fractions within a total of 7 - 8 days | Radiation: Stereotactic Radiotherapy<br>* Patients should be treated with 50 Gy in 5 fractions within a total of 7 - 8 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resection rate for all patients starting SBRT | Resection rate for all patients starting SBRT | 12 month | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stereotactic Radiotherapy