Adaptive Radiation Boost for Rectal Cancer
This study is testing if an extra, adaptive radiation treatment after standard chemoradiation is safe and helpful for people with rectal adenocarcinoma (a type of rectal cancer). The goal is to better target aggressive cancer cells while protecting healthy tissues and reducing side effects. You would first receive standard radiation (45 Gy in 25 sessions) along with a chemotherapy pill called capecitabine. Then, you would get extra radiation, with MRI scans every two weeks to adjust the treatment based on how your tumor responds. A small balloon will be used during treatment to help aim the radiation. The study is looking at how well this extra treatment works and if it causes side effects. It is open to adults aged 18 and older with T2-3, N0-1, M0 rectal cancer.
- Study design
- This is an interventional study with a planned enrollment of 37 participants. It is designed to evaluate the maximum tolerated dose (MTD) and feasibility of the adaptive radiation boost.
- What's involved
- You would first receive standard treatment, followed by extra radiation with MRI scans every two weeks. The adaptive radiation boost period is about 5 weeks, and side effects will be monitored for approximately 120 days after the last boost dose.
- Compensation
- Not stated in the trial record.
- Follow-up
- Side effects will be monitored for about 120 days after the last dose of the adaptive radiation boost.
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Adaptive Radiation Boost for Rectal Cancer
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Joshua Meyer · PRINCIPAL_INVESTIGATOR · Fox Chase Cancer Center
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- MTD will be evaluated by monitoring the rate of dose limiting toxicities (DLTs) defined as acute Grade 2+ gastrointestinal toxicity probably or definitely related to radiation.From the initiation of rectal adaptive radiotherapy boost to 90 days after the last dose of boost, for a total of ~ 120 days.
- Feasibility of a rectal boost that targets at least 90% of the rectal planning tumor volume with the 80% prescribed dose while limiting the outer 3 mm of the rectal wall to no more than 50% of the prescription dose delivered to 0.1cc.From the ART boost initiation to the end of the ART boost, for a period of ~ 5 weeks
Feasibility will be determined based on successful implementation and completion of standard chemoradiotherapy followed by experimental rectal adaptive radiotherapy boost utilizing CT-MR fusion that targets at least 90% of the rectal PTV\_Eval with the 80% prescribed dose while limiting the outer 3 mm of the rectal wall to no more than 50% of the prescription dose delivered to 0.1cc in ≥ 70% of ART fractions for the patient population enrolled in the study. This will be assessed at the MTD.