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

Locally Advanced Pancreatic Cancer Clinical Trial

— SBRT-PC-01  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03648632
• Other study ID #: KFE 18.13
• Status: Completed
• Phase: N/A
• Start date: August 22, 2018
• Est. completion date: March 31, 2022

Study information

• Verified date: April 2022
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

A Danish phase II study.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Locally Advanced Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Radiation:
• Stereotactic Radiotherapy
Patients should be treated with 50 Gy in 5 fractions within a total of 7 - 8 days.

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Per Pfeiffer

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resection rate for all patients starting SBRT	Resection rate for all patients starting SBRT	12 month
Secondary	1 year survival for all patients starting SBRT	1 year survival for all patients starting SBRT	12 month
Secondary	Progression-free survival (PFS)	PFS will be calculated from the date of registration to the date of documented progressive disease	12 month
Secondary	Overall survival (OS)	OS will be calculated from the date of registration to the date of documented progressive disease	12 month
Secondary	Adverse events grade 2-5 (NCI-CTCAE 4.1)	Adverse events grade 2-5 (NCI-CTCAE 4.1)	12 month
Secondary	Surgical complications, including irreversible electroporation (IRE) (Clavien-Dindo)	Complication rate will be gathered.	30 days
Secondary	Mortality	Mortality rate	30 days
Secondary	Mortality	Mortality rate	90 days