Additional Treatment for Isolated Local Pancreatic Cancer Recurrence Using Stereotactic Body Radiation Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUMC Utrecht
About this trial
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
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Additional stereotactic body radiation therapy
Treatment groups
174 Participants
are divided into 2 treatment groupsSponsors and collaborators
UMC Utrecht
Lead sponsor
Dutch Pancreatic Cancer Group (DPCG)
Collaborator
Source ClinicalTrials.gov