Stereotactic body radiation therapy for isolated local pancreatic cancer recurrence

A Randomized Controlled Trial on Additional Treatment for Isolated Local Pancreatic Cancer Recurrence Using Stereotactic Body Radiation Therapy

This trial will test if adding stereotactic body radiation therapy (SBRT) to standard care helps people with an isolated local recurrence of pancreatic cancer live longer and have better quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 174 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: UMC Utrecht (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 3 sites (Amsterdam, North Holland and 2 other locations)
• Trial ID: NCT04881487 on ClinicalTrials.gov

What this trial studies

This multicenter randomized controlled trial uses a 'trials within cohorts' (TwiCs) design nested in the Dutch PACAP prospective cohort to test whether adding stereotactic body radiation therapy (SBRT) to standard care improves outcomes for patients with isolated local recurrence of pancreatic ductal adenocarcinoma. Eligible participants who had prior resection and present with isolated local recurrence without distant metastases are randomized to receive SBRT plus standard care or standard care alone. The primary outcome is survival after recurrence, with the most important secondary endpoint being quality of life and additional endpoints including treatment response, toxicity, progression-free survival, and local progression-free survival. SBRT delivers image-guided high-dose localized radiation intended to ablate the recurrent lesion while limiting dose to nearby organs, and treatment and imaging follow predefined multicenter protocols.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18) enrolled in the PACAP cohort with written consent, who have an isolated local recurrence after prior PDAC resection, no distant metastases, and are eligible for the required MRI/CT imaging and SBRT planning.

Not a fit: Patients with distant metastases, an expected lifespan under three months, those ineligible for required imaging or SBRT, or those with resectable recurrences that can be treated by re-resection are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, adding SBRT could improve local tumor control and potentially prolong survival and quality of life for patients with isolated local PDAC recurrence.

How similar studies have performed: Early retrospective series have suggested SBRT can improve local control in isolated local PDAC recurrence, but randomized evidence is currently limited.

Eligibility criteria

Inclusion Criteria:

* Participation in the PACAP cohort with written informed consent for being randomized in future studies
* Isolated local recurrence after primary PDAC resection
* Minimum age of 18 years

Exclusion Criteria:

* Distant metastases
* Expected lifespan \< 3 months
* Ineligibility for MRI or CT according to the protocol of the local radiology department;
* Highly selective cases with resectable, isolated local recurrence without the need for either systemic or local ablative induction therapy, eligible for re-resection according to the expert panel.

Where this trial is running

Amsterdam, North Holland and 2 other locations

• Amsterdam University Medical Center, VUmc — Amsterdam, North Holland, Netherlands (Recruiting)
• Erasmus University Medical Center — Rotterdam, South Holland, Netherlands (Recruiting)
• University Medical Center Utrecht — Utrecht, Utrecht, Netherlands (Recruiting)

Study contacts

• Principal investigator: M. P.W. Intven, MD, PhD — Regional Academic Cancer Center Utrecht (RACU)
• Study coordinator: M. P.W. Intven, MD PhD

Conditions Recurrent Pancreatic Ductal Adenocarcinoma; Stereotactic body radiation therapy