Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) in Recurrent Rectal Cancer
NCT ID: NCT04827732
Last Updated: 2025-09-29
Study Results
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View full resultsBasic Information
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TERMINATED
NA
15 participants
INTERVENTIONAL
2021-05-04
2024-11-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 1 (30 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy
When feasible it is strongly recommended that radiotherapy begin on a Monday
MEVION S250i Hyperscan and Adaptive Aperture Proton Therapy Machine
-The device that will administer the IMPT
Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 2 (35 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy
When feasible it is strongly recommended that radiotherapy begin on a Monday
MEVION S250i Hyperscan and Adaptive Aperture Proton Therapy Machine
-The device that will administer the IMPT
Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 3 (40 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy
When feasible it is strongly recommended that radiotherapy begin on a Monday
MEVION S250i Hyperscan and Adaptive Aperture Proton Therapy Machine
-The device that will administer the IMPT
Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level -1 (25 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy
When feasible it is strongly recommended that radiotherapy begin on a Monday
MEVION S250i Hyperscan and Adaptive Aperture Proton Therapy Machine
-The device that will administer the IMPT
Interventions
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Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy
When feasible it is strongly recommended that radiotherapy begin on a Monday
MEVION S250i Hyperscan and Adaptive Aperture Proton Therapy Machine
-The device that will administer the IMPT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Michael Waters, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
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202103218
Identifier Type: -
Identifier Source: org_study_id
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