Status:
TERMINATED
Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) in Recurrent Rectal Cancer
Lead Sponsor:
Washington University School of Medicine
Conditions:
Recurrent Rectal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this trial is to determine the maximum tolerated dose (MTD) of hypofractionated IMPT for the reirradiation of locoregionally recurrent rectal cancer.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 18 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04827732
Start Date
May 4 2021
End Date
November 18 2024
Last Update
September 29 2025
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110