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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

Select...

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

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

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

Primary outcome measures

Local control rate

Secondary outcome measures

Complication rate

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

2021

Completed Phase 2

~410

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vanderbilt-Ingram Cancer CenterLead Sponsor

213 Previous Clinical Trials

60,893 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.

Media Library

$Hypofractionated Radiotherapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04506008 — Phase 2$

Soft Tissue Sarcoma Research Study Groups: Group I (UH HRT), Group II (MH HRT)

$Soft Tissue Sarcoma Clinical Trial 2023: Hypofractionated Radiotherapy Highlights & Side Effects. Trial Name: NCT04506008 — Phase 2$

$Hypofractionated Radiotherapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04506008 — Phase 2$

Frequently Asked Questions

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

Is Hypofractionated Radiotherapy potentially hazardous to individuals?

"While some evidence exists to suggest the safety of hypofractionated radiotherapy, there is no proof for its efficacy. Thus, it has been rated 2 on our 1-3 scale."

Answered by AI

What is the full breadth of participants taking part in this experiment?

"Affirmative. Clinicaltrials.gov provides evidence that this experiment is currently enrolling participants, having first been uploaded on March 2nd 2021 and last edited on July 6th 2022. 40 people are required to take part in the study at a single site."

Answered by AI

Are there any vacancies still available for this research project?

"Affirmative. Clinicaltrials.gov attests that this medical trial, which was first published on March 2nd 2021, is actively seeking patients for recruitment. Approximately 40 participants must be enlisted from a single research facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Hypofractionated Radiotherapy Followed by Surgical Resection in the Treatment of Soft Tissue Sarcomas

Eric Shinohara 2021. "Hypofractionated Radiotherapy Followed by Surgical Resection in the Treatment of Soft Tissue Sarcomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04506008.

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