Clinical trial NCT03648632: Stereotactic Radiotherapy (SBRT) in Patients With Locally Advanced Pancreatic Cancer (LAPC)
Official title: Stereotactic Radiotherapy (SBRT) in Patients With Locally Advanced Pancreatic Cancer (LAPC). A Danish Phase II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Locally Advanced Pancreatic Cancer
Keywords: Stereotactic Radiotherapy
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2018-08-27
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Stereotactic Radiotherapy (SBRT) in patients with locally advanced pancreatic cancer (LAPC).

A Danish phase II study.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Resection rate for all patients starting SBRT
timeFrame: 12 month
Secondary outcomes:
measure: 1 year survival for all patients starting SBRT
timeFrame: 12 month
measure: Progression-free survival (PFS)
timeFrame: 12 month
measure: Overall survival (OS)
timeFrame: 12 month
measure: Adverse events grade 2-5 (NCI-CTCAE 4.1)
timeFrame: 12 month
measure: Surgical complications, including irreversible electroporation (IRE) (Clavien-Dindo)
timeFrame: 30 days
measure: Mortality
timeFrame: 30 days
measure: Mortality
timeFrame: 90 days
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Odense Universitetshospital
name: Per Pfeiffer, Professor
role: PRINCIPAL_INVESTIGATOR
References: