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

The Washington University

Status: Terminated

Conditions: Recurrent Rectal Cancer

Treatments: Device: MEVION S250i Hyperscan and Adaptive Aperture Proton Therapy Machine; Radiation: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04827732

202103218

Details and patient eligibility

About

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

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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15 participants in 3 patient groups

Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)

Experimental group

Description:

* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 1. * 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).

Treatment:

Radiation: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy

Device: MEVION S250i Hyperscan and Adaptive Aperture Proton Therapy Machine

Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)

Experimental group

Description:

* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 2. * 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).

Treatment:

Radiation: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy

Device: MEVION S250i Hyperscan and Adaptive Aperture Proton Therapy Machine

Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)

Experimental group

Description:

* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 3. * 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).

Treatment:

Radiation: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy

Device: MEVION S250i Hyperscan and Adaptive Aperture Proton Therapy Machine