Using targeted radiation therapy combined with chemotherapy for inoperable pancreatic cancer

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

This study is testing whether adding targeted radiation therapy to standard chemotherapy can help people with inoperable pancreatic cancer live longer without their disease getting worse.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cancer Research Antwerp (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 9 sites (Edegem, Antwerpen and 8 other locations)
• Trial ID: NCT06691425 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with locally advanced or borderline resectable pancreatic adenocarcinoma who are medically unfit for surgery or refuse surgical intervention.

Not a fit: Patients with metastatic pancreatic cancer or those who are eligible for surgical resection may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve survival rates and quality of life for patients with inoperable pancreatic cancer.

How similar studies have performed: Previous studies have shown promising results with similar combinations of chemotherapy and SBRT, indicating potential for success in this approach.

Eligibility criteria

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 this trial is running

Edegem, Antwerpen and 8 other locations

• 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)
• AZ Groeninge — Kortrijk, Belgium (Recruiting)
• AZ Delta — Roeselare, Belgium (Recruiting)
• AZ Turnhout — Turnhout, Belgium (Recruiting)

Study contacts

• Study coordinator: Ines Joye, MD, PhD

Conditions Non-metastasized Unresectable Pancreatic Carcinoma; Pancreatic cancer; Randomized; stereotactic body radiation therapy; inoperable; non-metastasized