Adaptive Radiation Boost for Rectal Cancer

Conditions

• Rectum Cancer, Adenocarcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Adaptive Radiotherapy Boost — RADIATION
  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.

Study Details

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.

Key Dates

Start date

Oct 24, 2025

Status verified

Dec 2025

Primary completion

Nov 1, 2028

Completion

Nov 1, 2029

Study Design

Enrollment

37 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Adaptive Radiotherapy Boost Following Standard Pelvic Chemoradiation
  Adaptive Radiotherapy

Primary Outcome Measure

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. [ Time Frame: From the initiation of rectal adaptive radiotherapy boost to 90 days after the last dose of boost, for a total of ~ 120 days. ]

Central Contacts

• Joshua Meyer, MD
  215-728-2667
  [email protected]
• Jianli Hu, MD, PhD
  267-449-1431
  [email protected]

Locations (1)

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