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Stereotactic Body Radiation Therapy for Inoperable Non-metastasized Pancreatic Adenocarcinoma

NCT06691425 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-08-08

No results posted yet for this study

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.

Conditions

  • Non-metastasized Unresectable Pancreatic Carcinoma

Interventions

RADIATION

Stereotactic Body Radiation Therapy (SBRT)

SBRT (5 x 8 Gy)

DRUG

Chemotherapy

Standard of care: mFOLFIRINOX or gemcitabine/nab-paclitaxel

Sponsors & Collaborators

  • Kom Op Tegen Kanker

    collaborator OTHER

  • Naslund Medical AB

    collaborator UNKNOWN

  • Varian Medical Systems

    collaborator INDUSTRY

  • Cancer Research Antwerp

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-19
Primary Completion
2030-07-31
Completion
2030-07-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06691425 on ClinicalTrials.gov