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RECRUITING
NCT06691425
NA

Stereotactic Body Radiation Therapy for Inoperable Non-metastasized Pancreatic Adenocarcinoma

Sponsor: Cancer Research Antwerp

View on ClinicalTrials.gov

Summary

This is a multicenter randomized phase II trial that aims to include 160 patients with a non-metastatic (localized), inoperable pancreatic tumor. The study will take place at multiple centers across Europe. The primary objective of the study is to demonstrate superiority in progression free survival (PFS) by adding stereotactic body radiation therapy (SBRT) to chemotherapy for patients with an inoperable non-metastasized pancreatic tumor. SBRT is a radiotherapy technique (i.e. destroying cancer cells by means of ionizing irradiation) in which tumors can be irradiated with a high radiation dose. Surrounding healthy tissue is thus spared to the maximum extent. The primary endpoint of the TORPEDO study is 2-year PFS defined as the percentage of patients who are free of disease progression at 110 weeks after the date when the patients were drawn into 2 treatment groups (i.e. randomization). Secondary outcomes are, among others, quality of life, acute and late toxicity (i.e. adverse events), metastasis-free survival, local progression-free survival, overall survival, subsequent resectability, R0 resection and surgical morbidity. During the study, patients without disease progression after 3 months of induction chemotherapy will be randomized 1:1 to either treatment with chemotherapy or treatment with a combination of chemotherapy and SBRT (5 x 8 Gy). After randomization, ten-weekly follow-up visits will occur during two years to evaluate the quality of life, general blood parameters and general health condition of the patient. Moreover, toxicity will be evaluated as well as efficiency and safety of the treatment (e.g. by means of imaging). At any time during this follow-up period, imaging (CT scan, MRI scan) will be used to determine whether surgery can still be performed to improve patient survival.

Official title: Stereotactic Body Radiation Therapy for Inoperable Non-metastasized Pancreatic Adenocarcinoma: a Randomized Phase II Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2024-07-19

Completion Date

2030-07

Last Updated

2025-08-08

Healthy Volunteers

No

Interventions

RADIATION

Stereotactic Body Radiation Therapy (SBRT)

SBRT (5 x 8 Gy)

DRUG

Chemotherapy

Standard of care: mFOLFIRINOX or gemcitabine/nab-paclitaxel

Locations (9)

UZA

Edegem, Antwerpen, Belgium

ZAS Augustinus

Wilrijk, Antwerp, Belgium

AZ Klina

Brasschaat, Belgium

AZ Sint-Jan

Bruges, Belgium

ZOL

Genk, Belgium

Jessa ziekenhuis

Hasselt, Belgium

AZ Groeninge

Kortrijk, Belgium

AZ Delta

Roeselare, Belgium

AZ Turnhout

Turnhout, Belgium