RecruitingPhase 2NCT06453486

A Study of High Dose Radiation Therapy for Locally Advanced Pancreatic Cancer That Responded to Initial Chemotherapy Treatment

Ablative Radiation Therapy With High Dose Geometric Boost for Locally Advanced Pancreatic Cancer Patients Following Treatment Response Evaluation of Standard of Care Induction Chemotherapy (ABLATE): a Phase II Clinical Trial

Sponsor

University Health Network, Toronto

Enrollment

43 participants

Start Date

Mar 12, 2025

Study Type

INTERVENTIONAL

Conditions

Locally Advanced Pancreatic Adenocarcinoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests high-dose radiation therapy for patients with locally advanced pancreatic cancer (cancer that has grown into nearby structures but hasn't spread to other organs) that responded well to initial chemotherapy. The goal is to use higher radiation doses, which may control the cancer longer. **You may be eligible if...** - You have locally advanced pancreatic cancer confirmed by biopsy or cell analysis - Your tumor is less than 8 cm and has not progressed after at least 16 weeks of first-line chemotherapy - You are in good health (ECOG 0 or 1) with a life expectancy greater than 6 months - You are 18 or older and not currently pregnant or breastfeeding **You may NOT be eligible if...** - Your cancer has spread to other organs (metastatic) - Your cancer progressed during chemotherapy - You have had prior radiation to the same area Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONHigh dose radiation therapy

High dose radiation refers to the administration of a concentrated beam of radiation to target and treat the tumor. High dose radiation therapy typically involves delivering radiation in fractions over a set period. For instance, options such as: * 50Gy/5Fx: 50 Gray delivered over 5 fractions, administered every other day over 2 weeks. * 67.5Gy/15Fx: 67.5 Gray delivered over 15 fractions, administered once a day over 3 weeks. * 75Gy/25Fx: 75 Gray delivered over 25 fractions, administered once a day over 5 weeks. These numbers denote the total dose of radiation (in Gray, abbreviated as Gy) delivered over a specific number of fractions (abbreviated as Fx), and the respective time frames for administration. The selection of radiation therapy (RT) dose levels for participants is guided by the expertise and evaluation of the radiation oncologist.

Locations(2)

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

McGill University Health Centre

Montreal, Quebec, Canada

View Full Details on ClinicalTrials.gov

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NCT06453486

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