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Adaptive Radiation Boost for Rectal Cancer

NCT07221058 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2025-12-09

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Varian Medical Systems

    collaborator INDUSTRY

  • Fox Chase Cancer Center

    lead OTHER

Principal Investigators

  • Joshua Meyer · Fox Chase Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-24
Primary Completion
2028-11-01
Completion
2029-11-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07221058 on ClinicalTrials.gov