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Radiation Therapy

Short-Course Radiotherapy + Surgery for Soft Tissue Sarcoma

Phase 2

Recruiting

Led By Eric Shinohara, MD

Research Sponsored by Vanderbilt-Ingram Cancer Center

Eligibility Criteria Checklist

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

Must have

ECOG performance status 0-2

Histologic diagnosis of a soft tissue sarcoma of extremity, pelvis, chest wall or trunk/abdominal wall (non-retroperitoneal location)

Must not have

History of prior radiation to the same area to be irradiated

Patients with planned neoadjuvant chemotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a shorter, more intense course of radiation to treat soft tissue sarcomas. The hope is that it will allow patients to be treated more quickly with similar rates of controlling the cancer.

Who is the study for?

This trial is for individuals with a confirmed diagnosis of soft tissue sarcoma located in the limbs, pelvis, chest wall or non-retroperitoneal abdominal wall. Participants should be able to perform daily activities (ECOG status 0-2) and must be fit for radiation treatment and surgery. It's not open to those who've had prior radiation in the same area, have metastatic disease, are pregnant, will receive neoadjuvant chemotherapy, or have certain diseases that increase radiation side effects.

What is being tested?

The study is testing two shorter courses of hypofractionated radiotherapy (5 or 15 days) followed by surgical removal of the tumor in patients with soft tissue sarcoma. This approach is compared against the traditional longer course (5 weeks) to see if it can reduce treatment time without increasing wound complications or chances of cancer returning.

What are the potential side effects?

Potential side effects from hypofractionated radiotherapy may include skin irritation at the treatment site, fatigue, swelling due to fluid buildup (lymphedema), muscle stiffness around treated areas and delayed wound healing post-surgery.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself and am up and about more than half of the day.

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My cancer is a type of soft tissue sarcoma located in my limbs, pelvis, chest wall, or abdominal wall.

Exclusion Criteria

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

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I have had radiation treatment on the same area before.

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I am scheduled for chemotherapy before surgery.

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My cancer has spread to other parts of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 2 years

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

Treatment Details

Study Objectives

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

Primary study objectives

Local control rate

Secondary study objectives

Complication rate

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group II (MH HRT)Experimental Treatment3 Interventions

Patients undergo HRT daily for a total of 15 fractions followed by surgery.

Group II: Group I (UH HRT)Experimental Treatment3 Interventions

Patients undergo HRT daily for a total of 5 fractions followed by surgery.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Resection

2020

Completed Phase 2

~1440

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vanderbilt-Ingram Cancer CenterLead Sponsor

217 Previous Clinical Trials

63,516 Total Patients Enrolled

Eric Shinohara, MD5.02 ReviewsPrincipal Investigator - Vanderbilt Medical Center

Vanderbilt-Ingram Cancer Center

5Patient Review

Dr. Shinohara was very patient with me as we discussed the pros and cons of various treatment options for my prostate cancer. In the end, he recommended a course of action that he thought would be best for me. I would definitely recommend him to others.