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Proton Beam Therapy

Proton Therapy for Rectal Cancer Recurrence (IMPARC Trial)

N/A

Recruiting

Led By Hyun Kim, M.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of biopsy-proven adenocarcinoma of the rectum, anus or rectosigmoid junction of any stage now with recurrent disease in the pelvis

ECOG performance status 0-2

Must not have

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or unstable angina pectoris

Patients with pre-existing radiosensitizing conditions, such as connective tissue disorders (i.e. lupus, scleroderma) and genetic mutations (i.e. ataxia-telangiectasia)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up prior to start of radiation therapy, 1-2 weeks post radiation therapy, 3 months post radiation therapy, 6 months post radiation therapy, 9 months post radiation therapy and 12 months post radiation therapy

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing how well different doses of radiation work in treating rectal cancer that has come back.

Who is the study for?

This trial is for adults who've had one round of radiation for rectal cancer and now have a recurrence in the pelvis. They must be generally fit (ECOG 0-2), able to consent, and use birth control if needed. Excluded are those with more than one prior pelvic radiation, other active cancers or serious illnesses, pregnant/breastfeeding women, or certain genetic conditions.

What is being tested?

The study tests how much of a new type of targeted proton therapy called hypofractionated IMPT can be given safely to treat recurrent rectal cancer. It uses advanced technology like MEVION S250i Hyperscan to deliver precise doses while minimizing damage to healthy tissue.

What are the potential side effects?

Potential side effects may include skin reactions at the treatment site, fatigue, digestive issues due to radiation exposure such as nausea or diarrhea, and possibly inflammation in nearby organs like the bladder or intestines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer in the rectum, anus, or rectosigmoid junction has come back in the pelvis.

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I can take care of myself and perform daily activities.

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I am 18 years old or older.

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I have had one round of radiation therapy for rectal cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any ongoing infections or heart issues.

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I have conditions like lupus or genetic mutations that make my tissues more sensitive to radiation.

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I have had more than one radiation treatment for rectal cancer.

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I have had radiation to my pelvis for a condition that is not rectal cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ prior to start of radiation therapy, 1-2 weeks post radiation therapy, 3 months post radiation therapy, 6 months post radiation therapy, 9 months post radiation therapy and 12 months post radiation therapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~prior to start of radiation therapy, 1-2 weeks post radiation therapy, 3 months post radiation therapy, 6 months post radiation therapy, 9 months post radiation therapy and 12 months post radiation therapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and prior to start of radiation therapy, 1-2 weeks post radiation therapy, 3 months post radiation therapy, 6 months post radiation therapy, 9 months post radiation therapy and 12 months post radiation therapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum tolerated dose (MTD) of reirradiation using hypofractionated IMPT

Secondary study objectives

Change in quality of life as measured by the EORTC QLQ-C30

Change in quality of life as measured by the EORTC QLQ-CR29

Clinical complete response rate

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)Experimental Treatment2 Interventions

* 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).

Group II: Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)Experimental Treatment2 Interventions

* 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).

Group III: Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)Experimental Treatment2 Interventions

* 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).

0 / 8Eligibility criteria met

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Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

2,000 Previous Clinical Trials

2,343,885 Total Patients Enrolled

Hyun Kim, M.D.Principal InvestigatorWashington University School of Medicine

7 Previous Clinical Trials

211 Total Patients Enrolled

Shahed N Badiyan, M.D.Principal InvestigatorWashington University School of Medicine

1 Previous Clinical Trials

20 Total Patients Enrolled

Media Library

$Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) (Proton Beam Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04827732 — N/A$

$Rectal Cancer Research Study Groups: Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT), Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT), Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)$

$Rectal Cancer Clinical Trial 2023: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) Highlights & Side Effects. Trial Name: NCT04827732 — N/A$

$Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) (Proton Beam Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04827732 — N/A$