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Proton Beam Therapy

Proton vs Photon Radiation for Retroperitoneal Sarcoma

Phase 1 & 2

Recruiting

Led By Thomas F. DeLaney, M.D.

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

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

Must have

Histologically proven primary soft tissue sarcoma of the retroperitoneum

Measurable disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing whether it's safe to give a higher dose of radiation to people with a type of cancer called retroperitoneal sarcoma. The radiation will be given before surgery to remove the tumor.

Who is the study for?

This trial is for people with a life expectancy over 2 years who have measurable, histologically confirmed primary soft tissue sarcoma in the retroperitoneum. It's not for those previously treated with radiation for this condition, pregnant or breastfeeding individuals, patients on other investigational drugs, those with multifocal disease or metastases, sensitivity to radiation therapy, HIV on anti-retrovirals, uncontrolled illnesses, recent chemotherapy recipients within 4 weeks prior to the study start date.Check my eligibility

What is being tested?

The study tests two FDA-approved radiation therapies: proton beam therapy (IG-IMPT) and IMRT before surgery to remove retroperitoneal sarcomas. The goal is to find the safest high dose of these radiations that can be given by targeting most of the tumor and giving an extra boost to higher risk areas.See study design

What are the potential side effects?

While proton radiation aims to minimize side effects by being more targeted than traditional photon-based treatments like IMRT, potential side effects may include skin reactions at the treatment site, fatigue due to energy expenditure during recovery from cellular damage caused by radiation exposure.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is a type of sarcoma that started in the tissue behind my stomach.

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My cancer can be measured by tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase I: Determine MTD

Phase II: Determine Local Control Rate

Secondary outcome measures

Overall Survival

Pathologic Response

Progression-Free Survival Times

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Treatment Arm IMRTExperimental Treatment1 Intervention

IG IMRT with SIB to the high risk margin

Group II: Treatment Arm IMPTExperimental Treatment1 Intervention

IG-IMPT with SIB to the high risk margin

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicOTHER

3,212 Previous Clinical Trials

3,766,958 Total Patients Enrolled

Rush University Medical CenterOTHER

422 Previous Clinical Trials

163,421 Total Patients Enrolled

Massachusetts General HospitalLead Sponsor

2,933 Previous Clinical Trials

13,198,401 Total Patients Enrolled

Media Library

IG-IMPT (Proton Beam Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01659203 — Phase 1 & 2

Retroperitoneal Sarcoma Research Study Groups: Treatment Arm IMRT, Treatment Arm IMPT

Retroperitoneal Sarcoma Clinical Trial 2023: IG-IMPT Highlights & Side Effects. Trial Name: NCT01659203 — Phase 1 & 2

IG-IMPT (Proton Beam Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01659203 — Phase 1 & 2

Frequently Asked Questions

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

Are there any vacancies available in this clinical experiment?

"Indeed, the clinicaltrials.gov website reveals that this research trial has commenced its recruitment process. It was originally posted on December 1st 2012 and most recently modified on September 1st 2020; targeting 80 volunteers from 10 medical institutions."

Answered by AI

How many participants are engaged in this experiment?

"Affirmative, the information stored on clinicaltrials.gov confirms that this trial is still recruiting participants. It was initially posted on December 1st 2012 and has been updated as recently as September 1st 2020. The study seeks to enrol 80 patients from 10 separate medical centres."

Answered by AI

How widespread is this trial's implementation across hospitals?

"The University of Utah in Salt Lake City, Washington University School of Medicine Siteman Cancer Center South County located in Saint Louis, and Rush University Medical Center based out of Chicago are three trial sites. An additional 10 medical centres will also be enrolling patients for this study."

Answered by AI

What aims has this trial set out to achieve?

"This two-year trial is aimed at establishing the percentage of local control, along with a set of secondary objectives such as estimating overall survival, tumor response (via comparison of imaging data), and pathologic response (percentage necrosis & margin status)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Proton or Photon RT for Retroperitoneal Sarcomas

Tom DeLaney, MD 2012. "Proton or Photon RT for Retroperitoneal Sarcomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01659203.

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