Using targeted radiation therapy combined with chemotherapy for inoperable pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter randomized trial aims to enroll 160 patients with non-metastatic, inoperable pancreatic adenocarcinoma to evaluate the effectiveness of adding stereotactic body radiation therapy (SBRT) to standard chemotherapy. Participants will undergo a screening phase to assess eligibility, followed by 12 weeks of induction chemotherapy. After restaging, patients will be randomized to receive either chemotherapy alone or chemotherapy plus SBRT, with the primary goal of improving progression-free survival at two years. Secondary outcomes will include quality of life assessments and monitoring for adverse events.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* Massive gastric or intestinal invasion as assessed on imaging and/or endoscopy. Direct invasion of the duodenal mucosa as visible on endoscopic ultrasound (EUS).
* Prior radiation therapy that could hamper adequate dose delivery
* Contraindication to magnetic resonance imaging (MRI)
* 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.
* Patient already included in another clinical trial that would interfere with the TORPEDO clinical trial, as assessed by the Investigator.
* 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, including distal nodal involvement beyond the peripancreatic tissues and/or distant metastases
* Massive gastric or intestinal invasion as assessed on imaging and/or endoscopy. Direct invasion of the duodenal mucosa as visible on EUS.
* Known presence of an active ulcer (i.e. detected during standard of care diagnostic assessments)

Where it's running

• Uza
  Edegem, Antwerpen, Belgium Recruiting
• ZAS Augustinus
  Wilrijk, Antwerp, Belgium Recruiting
• AZ Klina
  Brasschaat, Belgium Recruiting
• AZ Sint-Jan
  Bruges, Belgium Recruiting
• Zol
  Genk, Belgium Recruiting
• Jessa ziekenhuis
  Hasselt, Belgium Recruiting

Study contacts

• Study coordinator: Ines Joye, MD, PhD
• Email: gza.cancertrials@zas.be
• Phone: 034433759

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.