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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
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

IMPARC Trial 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.Check my eligibility
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.See study design
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.

IMPARC Trial 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.

IMPARC Trial 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
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose (MTD) of reirradiation using hypofractionated IMPT
Secondary outcome measures
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
+5 more

IMPARC 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).

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,933 Previous Clinical Trials
2,299,705 Total Patients Enrolled
Hyun Kim, M.D.Principal InvestigatorWashington University School of Medicine
7 Previous Clinical Trials
221 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for enrollees to join this clinical trial?

"As shown on clinicaltrials.gov, this study is still recruiting patients and was posted to the site in May of 2021 with a subsequent update occurring in November of that same year."

Answered by AI

What is the estimated population size for this medical study?

"Affirmative. According to the information found on clinicaltrials.gov, this study is still conscripting test subjects and was initially posted on May 4th 2021 with its most recent update occurring November 23rd of the same year. A total of 20 volunteers are needed for a single medical centre location."

Answered by AI

Who else is applying?

What state do they live in?
Missouri
How old are they?
18 - 65
What site did they apply to?
Washington University School of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) in Recurrent Rectal Cancer
2021. "Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) in Recurrent Rectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04827732.
~3 spots leftby Nov 2024
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