About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Metastatic disease at the time of registration
Age<18.
Patients who have had prior systemic treatment (chemotherapy or any other anti-cancer agent) in the metastatic setting.
Prior radiotherapy to the upper abdomen region that would result in overlap of RT volume for the current study.
Trial design
Single group
Treatments tested in this trial
High dose radiation therapy
RadiationHigh 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.
Treatment groups
Trial outcomes
Primary outcomes
Overall survival (OS)
To evaluate the efficacy of ablative radiation therapy with high dose geometric boost for patients with locally advanced pancreatic cancer with stable disease or partial response following standard of care induction chemotherapy, as measured by median overall survival (OS).
Sponsors and contacts
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