New adaptive radiation trial aims to hit cancer harder, spare healthy tissue
NCT ID NCT07221058
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests whether giving extra, MRI-guided radiation after standard treatment is safe and effective for people with rectal cancer. About 37 participants will first receive standard chemoradiation, then get additional radiation that adjusts every two weeks based on tumor changes. The goal is to better target aggressive cancer cells while protecting nearby healthy tissue and reducing side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 37 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Nov 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subjects must have histologically or cytologically confirmed rectal adenocarcinoma. 2. 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. 3. Subjects must be willing to undergo MRI scans. 4. Age ≥18 years. 5. ECOG performance status 0 or 1. 6. Estimated survival of ≥ 12 months. 7. Subjects must have normal organ and marrow function as defined below * 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. Exclusion Criteria: 1. Subjects who have been previously treated for rectal cancer are excluded. 2. Subjects with rectal cancer involving the anal canal are excluded. (Rectal cancer abutting the anal canal will be allowed.) 3. Subjects must not be receiving any other investigational agents. 4. Subjects may not have had prior pelvic radiation. 5. Subjects should not have had a cancer actively treated within the last 3 years, excluding non-melanoma skin cancer. 6. 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. 7. Any condition or significant co-morbidity that prevents safe delivery of ART per the discretion of the treating physician(s). 8. Subjects must not be pregnant or breast-feeding.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fox Chase Cancer Center
RECRUITINGPhiladelphia, Pennsylvania, 19111, United States