NCT07221058

Adaptive Radiation Boost for Rectal Cancer

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (estimated)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rectum Cancer, Adenocarcinoma

Interventions

Type	Name	Description
RADIATION	Adaptive 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.

Timeline

• Start date: 2025-10-24
• Primary completion: 2028-11-01
• Completion: 2029-11-01
• First posted: 2025-10-27
• Last updated: 2025-12-09

Locations

1 site across 1 country: United States