Under construction – not a live service
Sign in
Taking people in BelgiumNo phase

Radiation added to chemotherapy for inoperable localized pancreatic cancer

Tests radiation added to chemotherapy in adults with inoperable, localized pancreatic cancer.

Key facts

Who runs it
Cancer Research Antwerp
Where
Brasschaat, Bruges, Edegem, Genk, Hasselt, Kortrijk, Roeselare, Turnhout, and Wilrijk, BelgiumSee the 9 sites
Trial code
Registry title
Stereotactic Body Radiation Therapy for Inoperable Non-metastasized Pancreatic Adenocarcinoma
Status
Recruiting
People taking part
160 people, planned
Started
19 Jul 2024
Expected to end
Jul 2030
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Stereotactic Body Radiation Therapy (SBRT)
  • Chemotherapy
Record updated
8 August 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with pancreatic cancer that has not spread and cannot be removed by surgery. It tests adding focused high-dose radiation (SBRT) to chemotherapy.

Age
Over 18 years
Sex
Women and men can join.
Disease stage
Pancreatic adenocarcinoma that is locally advanced, or borderline resectable if the person is medically unfit for surgery or refuses surgery. No spread to other organs.
Earlier treatment
Must have had 3 months of induction chemotherapy without disease progression before being randomized. Prior radiation therapy that could hamper adequate dose delivery is not allowed.
Biomarker or test result
Blood counts, kidney function and liver function must be adequate (for example neutrophils at least 1500/mm^3, platelets at least 100000/mm^3, hemoglobin at least 9 g/dl). ECOG performance status 0-2.

Main reasons for not taking part

  • Cancer that has spread outside the pancreas, including distant lymph nodes or other organs
  • Massive invasion of the stomach or intestine, or active ulcer
  • Prior radiation therapy that could hamper adequate dose delivery
  • Cannot have an MRI scan
  • Another cancer in the past 2 years (some exceptions)

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • Participant must be over 18 years of age
  • Participant is able and willing to provide written informed consent which includes compliance with and ability to undergo all study procedures and attend the scheduled follow-up visits per protocol
  • Either locally advanced or borderline resectable pancreatic adenocarcinoma, as confirmed by diagnostic images (CT, MRI or PET-CT scan) and based on vessel involvement according to the NCCN guidelines. Only borderline resectable pancreatic cancer (BRPC) patients who are medically unfit for surgery or refusing surgery can be included
  • Adequate organ function determined by the following laboratory values:; Adequate bone marrow function: absolute neutrophil count ≥1500/mm\^3, platelet count ≥100000/mm\^3 and hemoglobin ≥9 g/dl; Adequate renal function: Creatinine ≤1.5 x upper normal limit of normal (ULN) or estimated eGFR more than 45 ml/min; Adequate liver function: total bilirubin ≤1.5 ULN (after adequate biliairy stenting with metal stent) and alanine aminotransferase (ALT) ≤5x ULN
  • An Eastern Cooperative Oncology Group (ECOG) performance status grade of 0-2
  • A life expectancy ≥3 months
  • A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:; Is not a woman of child bearing potential or; A woman of child bearing potential must have a negative serum pregnancy test at screening and must use a very effective method of birth control

Who cannot take part

  • Prior radiation therapy that could hamper adequate dose delivery
  • Known presence of an active ulcer (i.e. detected during standard of care diagnostic assessments); Additional exclusion criteria after restaging (i.e. within 1 week after 3 months of induction chemotherapy) and prior to randomization:
  • Extrapancreatic metastatic disease as defined on diagnostic imaging (CT, MRI or PET-CT scan) or laparoscopy, including distal nodal involvement beyond the peripancreatic tissues and/or distant metastases
  • Diagnosis of another malignancy within 2 years prior to randomization, except non-melanoma skin cancer, non-invasive bladder cancer, carcinoma in situ of the cervix or non-metastatic prostate cancer. Patients with a history of other malignancies are eligible if they have been continuously disease-free for at least 2 years after definitive primary treatment
  • Any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject
  • Extrapancreatic metastatic disease as defined on diagnostic imaging, including distal nodal involvement beyond the peripancreatic tissues and/or distant metastases
  • Known presence of an active ulcer (i.e. detected during standard of care diagnostic assessments)
  • Massive gastric or intestinal invasion as assessed on imaging and/or endoscopy. Direct invasion of the duodenal mucosa as visible on endoscopic ultrasound (EUS)
  • Contraindication to magnetic resonance imaging (MRI)
  • Patient already included in another clinical trial that would interfere with the TORPEDO clinical trial, as assessed by the Investigator
  • Massive gastric or intestinal invasion as assessed on imaging and/or endoscopy. Direct invasion of the duodenal mucosa as visible on EUS

Where in Belgium

  • AZ KLINABrasschaat, BelgiumContact: Wim Demey, MD, PhD (principal investigator)Taking people
  • AZ Sint JanBruges, BelgiumContact: Isabel Hutsebaut, MD, PhD (principal investigator)Taking people
  • UZAEdegem, BelgiumContact: Timon Vandamme, MD, PhD (principal investigator)Taking people
  • ZOLGenk, BelgiumContact: Philippe Bulens, MD, PhD (principal investigator)Taking people
  • JESSA ZiekenhuisHasselt, BelgiumContact: Katleen Verboven, MD, PhD (principal investigator)Taking people
  • AZ GroeningeKortrijk, BelgiumContact: Karin Stellamans, MD, PhD (principal investigator)Taking people
  • AZ DeltaRoeselare, BelgiumContact: Barbara Bussels, MD, PhD (principal investigator)Taking people
  • AZ TurnhoutTurnhout, BelgiumContact: Michel Martens, MD, PhD (principal investigator)Taking people
  • ZAS AugustinusWilrijk, BelgiumContact: Ines Joye, MD, PhDTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Arm A: Chemotherapy aloneExisting treatment, for comparison

    Patients in arm A will receive standard treatment, more specifically chemotherapy (mFOLFIRINOX or Gemcitabine/nab-paclitaxel) alone. After the 12 weeks of induction chemotherapy followed by randomization, these patients will receive further chemotherapy. A maximal total duration of 24 weeks of chemotherapy (including induction chemotherapy) will be administered for patients in arm A undergoing R0/R1 resection. Duration of chemotherapy for patients in arm A not undergoing R0/R1 resection is left at the discretion of the treating physician.

    Treatment: Chemotherapy

  • Arm B: Chemotherapy with SBRTTreatment being tested

    Patients in arm B will receive SBRT in addition to chemotherapy (mFOLFIRINOX or Gemcitabine/nab-paclitaxel). After the 12 weeks of induction chemotherapy followed by randomization, these patients will receive another month of chemotherapy. Fiducial markers are implanted (unless MR LINAC is used to deliver radiotharapy) prior to the administration of SBRT, which will start 14 days (+/- 1 week) after either the first day of the eighth cycle of mFOLFIRINOX or the fifteenth day of the fourth cycle of Gemcitabine/nab-paclitaxel. 5 fractions of 8 Gy will be delivered. SBRT is preferably followed by further chemotherapy. The maximal total duration of chemotherapy for these patients is 24 weeks.

    Treatment: Stereotactic Body Radiation Therapy (SBRT) and Chemotherapy

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Stereotactic Body Radiation Therapy for Inoperable Non-metastasized Pancreatic Adenocarcinoma: a Randomized Phase II Study
Plain-language title
Radiation added to chemotherapy for inoperable localized pancreatic cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
8 August 2025