NCT04881487 Additional Treatment for Isolated Local Pancreatic Cancer Recurrence Using Stereotactic Body Radiation Therapy
| NCT ID | NCT04881487 |
| Status | Recruiting |
| Phase | — |
| Sponsor | UMC Utrecht |
| Condition | Recurrent Pancreatic Ductal Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 174 participants |
| Start Date | 2021-07-05 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 174 participants in total. It began in 2021-07-05 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
M. P.W. Intven, MD, PhD
PRINCIPAL INVESTIGATOR
Regional Academic Cancer Center Utrecht (RACU)
Frequently Asked Questions
Who can join the NCT04881487 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Recurrent Pancreatic Ductal Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04881487 currently recruiting?
Yes, NCT04881487 is actively recruiting participants. Contact the research team at m.intven@umcutrecht.nl for enrollment information.
Where is the NCT04881487 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands, Rotterdam, Netherlands, Utrecht, Netherlands.
Who is sponsoring the NCT04881487 clinical trial?
NCT04881487 is sponsored by UMC Utrecht. The principal investigator is M. P.W. Intven, MD, PhD at Regional Academic Cancer Center Utrecht (RACU). The trial plans to enroll 174 participants.