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Additional Treatment for Isolated Local Pancreatic Cancer Recurrence Using Stereotactic Body Radiation Therapy

RecruitingNAAges 18 Years - anyAllUMC Utrecht
NCT04881487 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

A randomized controlled trial, nested within an existing prospective cohort (Dutch Pancreatic Cancer Project; PACAP) according to the 'trials within cohorts' (TwiCs) design in which the effect of additional local ablative therapy compared to current standard of care alone, on survival after recurrence in patients with isolated local pancreatic ductal adenocarcinoma (PDAC) recurrence. The most important secondary endpoint is quality of life. Other secondary endpoints are treatment response, acute and late toxicity, overall survival, progression-free survival, local progression-free survival, distant metastases free survival and reasons for non-eligibility or exclusion.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Additional stereotactic body radiation therapy
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Where

3 sites
Amsterdam University Medical Center, VUmc
Amsterdam, Netherlands
Erasmus University Medical Center
Rotterdam, Netherlands
University Medical Center Utrecht
Utrecht, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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