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

NCT04827732 | Terminated Results DMC FDA Device

• 1 other identifier: 202103218
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD) of Reirradiation Using Hypofractionated IMPT

  * MTD is defined as the dose associated with a 35% probability of dose-limiting toxicity (DLT). * DLT is defined as any toxicity listed below that occurs within 6 months from start of treatment and is considered possibly, probably, or definitely related to proton reirradiation: * Any grade 5 toxicities * Any grade 4-5 GI toxicities * Bowel obstruction * Grade 3-5: diarrhea; anal, colonic, or bowel ulcers; bladder perforation; any fistula formations; peripheral motor/sensory neuropathy of the pelvis above baseline; osteonecrosis/soft tissue necrosis; radiation dermatitis; hematuria; hematochezia; bowel/pelvic hemorrhage; reproductive tract toxicity * Toxicity will be graded using CTCAE v5

  From start of treatment through 6 months

Secondary Outcomes (10)

• Clinical Complete Response Rate

  Within 6 weeks to 3 months post-completion of radiation therapy (range 7-14 weeks)

• Median Freedom From Locoregional Progression (FFLP)

  Through completion of follow-up (full range 1.81 months-13.87 months)

• Median Overall Survival (OS)

  Through completion of follow-up (full range 4.4 months to 13.87 months)

• Median Progression-free Survival (PFS)

  Through completion of follow-up (full range 1.81 months-13.87 months)

• Median Change in Quality of Life (QoL) Score as Measured by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

  Assessed at pre-treatment (baseline), 1-2 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment

Study Arms (4)

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

EXPERIMENTAL

* 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).

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

* 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).

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

* 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).

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

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

EXPERIMENTAL

* 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).

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

Interventions

Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy RADIATION

When feasible it is strongly recommended that radiotherapy begin on a Monday

Also known as: IMPT

Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT); Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT); Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT); Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)

MEVION S250i Hyperscan and Adaptive Aperture Proton Therapy Machine DEVICE

-The device that will administer the IMPT

Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT); Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT); Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT); Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Dr. Michael Waters
• Organization: Washington University School of Medicine

m.r.waters@wustl.edu

314-747-7236

Study Officials

• Michael Waters, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 1, 2021
• Study Start: May 4, 2021
• Primary Completion: July 29, 2024
• Study Completion: November 18, 2024
• Last Updated: September 29, 2025
• Results First Posted: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)