Status:
UNKNOWN
Stereotactic Radiotherapy vs Best Supportive Care in Unfit Pancreatic Cancer Patients
Lead Sponsor:
Amsterdam UMC, location VUmc
Collaborating Sponsors:
UMC Utrecht
Erasmus Medical Center
Conditions:
Pancreatic Cancer Non-resectable
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
SUMMARY Rationale: Pancreatic ductal adenocarcinoma (PDAC) is one of the most lethal cancers, its incidence increases with age. Many patients with localized (non-metastatic) PC have significant comorb...
Detailed Description
This study is a prospective multicenter randomized controlled trial according to the 'cohort multiple randomized controlled trial (cmRCT)'-design. This study will be nested within the existing prospec...
Eligibility Criteria
Inclusion
- Pathology proven localised (non-metastasized) PDAC
- Patients unfit for both surgery and systemic chemotherapy (i.e. KPS 50-70; WHO 2) • • Patients who choose to refrain from surgery or chemotherapy
- Written informed consent
Exclusion
- Age \<18 years
- Distant metastasis
- Imminent bowel obstruction
- Active bleeding
- Uncontrolled infection
- Contra-indications for MRI (only for VUmc and UMCU)
- Pacemakers or implanted defibrillators, deep brain stimulators, cochlear implants.
- Patients who have a metallic foreign body in their eye, or who have an aneurysm clip in their brain, cannot have an MRI scan since the magnetic field may dislodge the metal
- Patients with severe claustrophobia not able to tolerate an MRI scan
- Patients with a non-MR-compatible (hip/knee/jaw) prosthesis
Key Trial Info
Start Date :
October 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT05265663
Start Date
October 13 2020
End Date
June 1 2024
Last Update
March 3 2022
Active Locations (2)
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1
VUMedicalCenter
Amsterdam, North Holland, Netherlands, 1117 HV
2
UMCU
Utrecht, Netherlands, 3584CX