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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NCT07221058

Adaptive Radiation Boost for Rectal Cancer

Recruiting
PHASE1Ages 18+InterventionalTreatment
Fox Chase Cancer Center
~37 participants
Updated 2025-12-09 on ClinicalTrials.gov
What's tested:Adaptive Radiotherapy Boost

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over From the initiation of rectal adaptive radiotherapy boost to 90 days after the last dose of boost, for a total of ~ 120 days.
+1 more outcome measured
Rectum Cancer, Adenocarcinoma
1 sites across 1 states
Pennsylvania1
  • Joshua Meyer · PRINCIPAL_INVESTIGATOR · Fox Chase Cancer Center

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Eligibility criteria

Inclusion

Absolute neutrophil count \> =1,000/mcL
Platelets \>= 75,000/mcL
Total bilirubin \< 3 mg/dL 8. Subjects must be able to tolerate the chemotherapy regimens outlined in the treatment plan (Section 5.0), both before and after ART.
Before ART: Capecitabine at a dose of 825 mg/m²
After ART: FOLFOX combination chemotherapy, or 5-FU, or capecitabine 9. Subjects must possess the ability to understand and willingness to sign a written informed consent and HIPAA consent document. Translation services including translation of informed consent documents will be provided, as feasible, to encourage diversity of inclusion of eligible patients.
  • 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.