Adaptive Radiation Boost for Rectal Cancer (NCT07221058) | Clinical Trial Compass
RecruitingPhase 1
Adaptive Radiation Boost for Rectal Cancer
United States37 participantsStarted 2025-10-24
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subjects must have histologically or cytologically confirmed rectal adenocarcinoma.
. Subjects must have T2-3, N0-1, M0 rectal cancer. Staging will be done by MRI pelvis and CT chest and abdomen with contrast. PET-CT will be an acceptable alternative for the CT chest and abdomen.
. Subjects must be willing to undergo MRI scans.
. Age ≥18 years.
. ECOG performance status 0 or 1.
. Estimated survival of ≥ 12 months.
. Subjects must have normal organ and marrow function as defined below
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
Timeframe: From the initiation of rectal adaptive radiotherapy boost to 90 days after the last dose of boost, for a total of ~ 120 days.
2
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.
Timeframe: From the ART boost initiation to the end of the ART boost, for a period of ~ 5 weeks
. Subjects must be able to tolerate the chemotherapy regimens outlined in the treatment plan (Section 5.0), both before and after ART.
Exclusion criteria
. Subjects who have been previously treated for rectal cancer are excluded.
. Subjects with rectal cancer involving the anal canal are excluded. (Rectal cancer abutting the anal canal will be allowed.)
. Subjects must not be receiving any other investigational agents.
. Subjects may not have had prior pelvic radiation.
. Subjects should not have had a cancer actively treated within the last 3 years, excluding non-melanoma skin cancer.
. Subjects must not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
. Any condition or significant co-morbidity that prevents safe delivery of ART per the discretion of the treating physician(s).
. Subjects must not be pregnant or breast-feeding.