Status:
ENROLLING_BY_INVITATION
Additional Treatment for Isolated Local Pancreatic Cancer Recurrence Using Stereotactic Body Radiation Therapy
Lead Sponsor:
UMC Utrecht
Collaborating Sponsors:
Dutch Pancreatic Cancer Group (DPCG)
Conditions:
Recurrent Pancreatic Ductal Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
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 addi...
Detailed Description
Rationale: Disease recurrence remains the main cause of mortality in patients who underwent resection for PDAC. In case of recurrence, patients are currently treated with palliative chemotherapy or be...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT04881487
Start Date
July 5 2021
End Date
April 1 2026
Last Update
June 18 2023
Active Locations (3)
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1
Amsterdam University Medical Center, VUmc
Amsterdam, North Holland, Netherlands, 1081 HV
2
Erasmus University Medical Center
Rotterdam, South Holland, Netherlands, 3015 GD
3
University Medical Center Utrecht
Utrecht, Netherlands, 3584 CX