NL-OMON52822
Recruiting
Phase 2
PANcreatic Cancer lOcalized disease in frail or elderly patients unfit for both chemotherapy and surgery treated with Stereotactic Ablative Radiotherapy (PANCOSAR): a multicenter randomized controlled trial - PANCOSAR
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Vrije Universiteit Medisch Centrum
- Enrollment
- 98
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Pathology proven localised (non\-metastasized) PC
- •Patients unfit for both surgery and systemic chemotherapy (i.e. KPS 50\-70;
- •WHO 2 or favourable WHO3\) or patients who refuse surgery or chemotherapy.
- •In case of prior treatment with chemotherapy: A maximum of two cycles of
- •chemotherapy is aloud for inclusion. The interval between the last cycle of
- •chemotherapy and the first fraction of radiation therapy should be at least six
- •weeks. Additionally, in the case patient suffered from side effects of the
- •chemotherapy these have to score equal or below 1 (CTCAE v.5\.0\) in before the
- •first fraction of radiation therapy is delivered.
- •Written informed consent
Exclusion Criteria
- •Age \<18 years
- •Administration of more than two cycles of chemotherapy
- •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
Outcomes
Primary Outcomes
Not specified
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