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

NCT03648632 | Completed

• 1 other identifier: KFE 18.13
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Locally Advanced Pancreatic Cancer

Keywords

Stereotactic Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Resection rate for all patients starting SBRT

  Resection rate for all patients starting SBRT

  12 month

Secondary Outcomes (7)

• 1 year survival for all patients starting SBRT

  12 month

• Progression-free survival (PFS)

  12 month

• Overall survival (OS)

  12 month

• Adverse events grade 2-5 (NCI-CTCAE 4.1)

  12 month

• Surgical complications, including irreversible electroporation (IRE) (Clavien-Dindo)

  30 days

Study Arms (1)

Stereotactic Radiotherapy

EXPERIMENTAL

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

Radiation: Stereotactic Radiotherapy

Interventions

Stereotactic Radiotherapy RADIATION

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

Stereotactic Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Per Pfeiffer: lead

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 38815694 DERIVED

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Per Pfeiffer, Professor

  Odense Universitetshospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD, PhD

Study Record Dates

• First Submitted: June 20, 2018
• First Posted: August 27, 2018
• Study Start: August 22, 2018
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: April 20, 2022

Record last verified: 2022-04

Locations

DK (1)