Proton therapy aims to safely retreat recurrent rectal cancer
NCT ID NCT04827732
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study tested a precise type of proton radiation (IMPT) for people whose rectal cancer came back after prior radiation. The goal was to find the highest safe dose without causing severe side effects. The trial enrolled 15 adults and was terminated early.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Proton beam radiation (IMPT)
- What this could lead to
- If successful, this could offer a safer way to deliver additional radiation to people whose rectal cancer has returned after previous treatment.
- What could go wrong
- This was a very small, early-phase trial that was terminated early. It only looked at safety, not effectiveness, and the risk of serious side effects from repeat radiation is high.
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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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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15 people
The number who actually took part.
- Started
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May 2021
- Finished
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Nov 2024
- 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: * History of biopsy-proven adenocarcinoma of the rectum, anus or rectosigmoid junction of any stage now with recurrent disease in the pelvis * One prior course of radiation therapy to the pelvis for rectal cancer * ECOG performance status 0-2 * At least 18 years of age * Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. * Able to understand and willing to sign an IRB-approved written informed consent document. Exclusion Criteria: * Patients with pre-existing radiosensitizing conditions, such as connective tissue disorders (i.e. lupus, scleroderma) and genetic mutations (i.e. ataxia-telangiectasia) * A history of other malignancy with the exception of malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease, basal cell or squamous cell carcinoma of the skin that were treated with local resection only, or carcinoma in situ of the cervix. Patients with history of prostate cancer treated without radiotherapy and no evidence of disease are eligible * More than one prior course of radiation to the pelvis for rectal cancer * Prior radiation to the pelvis for disease other than rectal cancer * Tumor in the rectum/colon requiring radiation therapy to the full circumference of the rectum/colon. * Current treatment with any investigational agents. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or unstable angina pectoris * Pregnant and/or breastfeeding. Women of childbearing potential must have a negative urine or serum pregnancy test within 14 days of study entry.
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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.
Contacts and locations
Locations
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Washington University School of Medicine
St Louis, Missouri, 63110, United States
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