NCT06453486 A Study of High Dose Radiation Therapy for Locally Advanced Pancreatic Cancer That Responded to Initial Chemotherapy Treatment
| NCT ID | NCT06453486 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University Health Network, Toronto |
| Condition | Locally Advanced Pancreatic Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 43 participants |
| Start Date | 2025-03-12 |
| Primary Completion | 2030-04 |
Trial Parameters
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Brief Summary
The goal of this clinical trial is to test the effect of high-dose radiation therapy after initial chemotherapy in patients with locally advanced pancreatic cancer. The main question it aims to answer is: • For patients with locally advanced pancreatic cancer that responded to initial chemotherapy (stayed stable or decreased in size), will high-dose RT (radiation therapy) contribute to improving treatment outcomes, enhancing quality of life, or increasing overall survival rates? Participants will: * Undergo an optional tumor biopsy. * Be treated with high dose radiation therapy. * Complete quality of life questionnaires. * Donate research blood samples.
Eligibility Criteria
Inclusion Criteria: * Have a histological or cytological diagnosis of LAPC. * Have pancreatic tumour \<8.0 cm in greatest axial dimension at the time of treatment planning but final determination of eligibility will be based upon satisfying the radiation normal tissue constraints. * Eastern Cooperative Oncology Group (ECOG) performance status ≤1 (Karnofsky ≥70%). * Life expectancy of greater than 6 months, as judged by the investigator. * Patients must have had prior first-line chemotherapy for this cancer for at least 16 weeks without clinical or radiographic progression. There should be a washout of at least 2 weeks from first-line chemotherapy and start of therapy on clinical trial. * Ability to understand and willing to sign a written informed consent document. * Women must not be pregnant or breast-feeding. All females of child bearing potential must have a serum or urine pregnancy test to rule out pregnancy within 4 weeks prior to registration. All breastfeeding women should disc