Stereotactic Radiotherapy (SBRT) in Patients With Locally Advanced Pancreatic Cancer (LAPC) (SBRT-PC-01)

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

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

A Danish phase II study.

Study Overview

• Status: Completed
• Conditions: Locally Advanced Pancreatic Cancer
• Intervention / Treatment: Radiation: Stereotactic Radiotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Odense, Denmark, 5000
    • Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

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; Patients should be treated with 50 Gy in 5 fractions within a total of 7 - 8 days.

What is the study measuring?

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
Mortality	Mortality rate	30 days
Mortality	Mortality rate	90 days
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

Collaborators and Investigators

• Sponsor: Per Pfeiffer
• Investigators: Principal Investigator: Per Pfeiffer, Professor, Odense Universitetshospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 22, 2018
• Primary Completion (ACTUAL): March 31, 2022
• Study Completion (ACTUAL): March 31, 2022

Study Registration Dates

• First Submitted: June 20, 2018
• First Submitted That Met QC Criteria: August 24, 2018
• First Posted (ACTUAL): August 27, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 20, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Stereotactic Radiotherapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: KFE 18.13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No