Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) in Recurrent Rectal Cancer

  • End date
    May 31, 2025
  • participants needed
  • sponsor
    Washington University School of Medicine
Updated on 1 December 2021


The purpose of this trial is to determine the maximum tolerated dose (MTD) of hypofractionated IMPT for the reirradiation of locoregionally recurrent rectal cancer.

Condition Recurrent Rectal Cancer
Treatment Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy, MEVION S250i Hyperscan and Adaptive Aperture Proton Therapy Machine
Clinical Study IdentifierNCT04827732
SponsorWashington University School of Medicine
Last Modified on1 December 2021


Yes No Not Sure

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
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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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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