RecruitingPhase 1NCT07221058

Adaptive Radiation Boost for Rectal Cancer

Adaptive Radiation BOost for Rectal Cancer: a Phase I Dose Escalation Study (ARBOR)

Sponsor

Fox Chase Cancer Center

Enrollment

37 participants

Start Date

Oct 24, 2025

Study Type

INTERVENTIONAL

Conditions

Rectum Cancer, Adenocarcinoma

Summary

The goal of this clinical trial is to find out if giving extra adaptive radiation therapy after standard chemoradiation treatment is safe and helpful for people with rectal cancer. The main questions the study aims to answer are: * Can this approach help target the most aggressive cancer cells more accurately, while protecting nearby healthy tissue? * Can it reduce the side effects that people may experience during treatment? Participants will: * First receive standard treatment: radiation (45 Gy in 25 sessions) along with a chemotherapy pill called capecitabine. * Then get extra radiation using MRI scans every two weeks to adjust the treatment based on how the tumor responds. * Use a small balloon during treatment to help aim the radiation and protect healthy areas. * Finally, receive additional chemotherapy (such as FOLFOX) for four months.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an adaptive radiation technique for rectal cancer, where the radiation dose is personalized and boosted in real-time using MRI imaging during treatment — potentially allowing for higher precision with fewer side effects. **You may be eligible if...** - You are 18 or older - You have been confirmed to have rectal cancer (adenocarcinoma), Stage T2-T3, with limited or no lymph node involvement, and no distant spread - Your cancer is operable and your overall health (performance status) is good - Your blood counts and organ function are within acceptable ranges - You are able to tolerate the planned chemotherapy (capecitabine-based) **You may NOT be eligible if...** - You cannot undergo MRI scans - Your estimated survival is less than 12 months - Your blood counts or organ function fall below the required thresholds 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

RADIATIONAdaptive Radiotherapy Boost

Patients will receive one boost fraction every two weeks, targeting the primary tumor within the rectum plus a 2 mm Planning Target Volume (PTV) margin. Any regional lymph nodes that measure at least 5 mm in short axis on the day of treatment will receive treatment with the ART dose being given to the primary rectal tumor.

Locations(1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

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NCT07221058

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