Stereotactic body radiation therapy for isolated local pancreatic cancer recurrence

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 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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: m.intven@umcutrecht.nl
• Phone: 0630866525

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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.