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

NCT ID: NCT03648632

Last Updated: 2022-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-22
• Study Completion Date: 2022-03-31

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.

Conditions

Locally Advanced Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stereotactic Radiotherapy

50 Gy in 5 fractions within a total of 7 - 8 days

Group Type: EXPERIMENTAL

Stereotactic Radiotherapy

Intervention Type: RADIATION

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

Interventions

Stereotactic Radiotherapy

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

Intervention Type: RADIATION

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Per Pfeiffer

OTHER

Sponsor Role: lead

Responsible Party

Per Pfeiffer

Professor, MD, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Per Pfeiffer, Professor

Role: PRINCIPAL_INVESTIGATOR

Odense Universitetshospital

Locations

Odense University Hospital

Odense, , Denmark

Countries

Denmark

References

Weisz Ejlsmark M, Bahij R, Schytte T, Ronn Hansen C, Bertelsen A, Mahmood F, Bau Mortensen M, Detlefsen S, Weber B, Bernchou U, Pfeiffer P. Adaptive MRI-guided stereotactic body radiation therapy for locally advanced pancreatic cancer - A phase II study. Radiother Oncol. 2024 Aug;197:110347. doi: 10.1016/j.radonc.2024.110347. Epub 2024 May 28.

Reference Type: DERIVED

PMID: 38815694 (View on PubMed)

Other Identifiers

KFE 18.13

Identifier Type: -

Identifier Source: org_study_id