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Radiation Therapy

Pre-Surgery Hypofractionated Radiation Therapy for Soft Tissue Sarcoma

Q: Are there any vacancies still available to join this trial?

Clinicaltrials.gov confirms that the trial is still in need of participants; it was first published on November 30th 2020 and has been updated most recently on May 3rd 2022.

Q: Does Hypofractionated Radiation Therapy pose any risks to patients?

There is preliminary evidence that Hypofractionated Radiation Therapy is safe, so it earned a rating of 2.

Q: What is the aggregate sum of individuals participating in this clinical examination?

Affirmative. Credentialed on clinicaltrials.gov is the information that this medical trial, first posted November 30th 2020, is still searching for participants. A total of 120 individuals need to be enrolled from a single health facility.

Phase 2

Recruiting

Led By Safia K. Ahmed, M.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

No evidence of nodal or distant metastases as determined by clinical examination on any form of imaging

Eastern Cooperative Oncology Group (ECOG) performance status (PS) =< 3

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 5 years

Awards & highlights

Study Summary

This trial looks at a shorter, higher-dose radiation therapy to see if it decreases wound complications from surgery for patients with localized soft tissue sarcomas.

Who is the study for?

This trial is for adults with a type of cancer called soft tissue sarcoma in the arms, legs, or superficial trunk. It's for those who can have surgery to remove it and haven't had radiation in that area before. Participants need to be able to fill out questionnaires, use birth control if they can have children, and come back for follow-ups.Check my eligibility

What is being tested?

The study tests hypofractionated radiation therapy given over fewer days but at higher doses each day before surgery. The goal is to see if this shorter treatment reduces wound problems after surgery compared to traditional longer treatments.See study design

What are the potential side effects?

Potential side effects include skin irritation, fatigue, swelling in treated areas, and more serious risks like damage to nearby organs or tissues due to high-dose radiation exposure.

Eligibility Criteria

Inclusion Criteria

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

Select...

My scans show no cancer spread to lymph nodes or distant parts of the body.

Select...

I am capable of limited self-care and spend less than half of my day in bed or sitting.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 5 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

Proportion of patients who experience major wound complications

Secondary outcome measures

Change in quality of life - PROMIS-10

Change in quality of life - TESS

Disease

+5 more

Side effects data

From 2022 Phase 2 trial • 107 Patients • NCT03324802

80%

Dermatitis radiation

54%

Skin hyperpigmentation

48%

Pain

35%

Lymphedema

22%

Superficial soft tissue fibrosis

Skin hypopigmentation

Edema limbs

Device related infection

100%

80%

60%

40%

20%

Study treatment Arm

Arm 1 (Radiation Therapy, 15 Fractions)

Arm 2 (Hypofractionated Radiation Therapy, 5 Fractions)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (hypofractionated radiation therapy, resection)Experimental Treatment4 Interventions

Patients undergo hypofractionated radiation therapy QD (except weekends and holidays) over 3 weeks for a total of 15 fractions. Within 3-6 weeks after completion of radiation therapy, patients undergo surgical resection.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hypofractionated Radiation Therapy

2016

Completed Phase 2

~130

Resection

2021

Completed Phase 2

~410

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,206 Previous Clinical Trials

3,766,963 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,547 Total Patients Enrolled

Safia K. Ahmed, M.D.Principal InvestigatorMayo Clinic

Media Library

$Hypofractionated Radiation Therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04562480 — Phase 2$

$Soft Tissue Sarcoma Research Study Groups: Treatment (hypofractionated radiation therapy, resection)$

$Soft Tissue Sarcoma Clinical Trial 2023: Hypofractionated Radiation Therapy Highlights & Side Effects. Trial Name: NCT04562480 — Phase 2$

$Hypofractionated Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04562480 — Phase 2$

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 still available to join this trial?

"Clinicaltrials.gov confirms that the trial is still in need of participants; it was first published on November 30th 2020 and has been updated most recently on May 3rd 2022."

Answered by AI

Does Hypofractionated Radiation Therapy pose any risks to patients?

"There is preliminary evidence that Hypofractionated Radiation Therapy is safe, so it earned a rating of 2."

Answered by AI

What is the aggregate sum of individuals participating in this clinical examination?

"Affirmative. Credentialed on clinicaltrials.gov is the information that this medical trial, first posted November 30th 2020, is still searching for participants. A total of 120 individuals need to be enrolled from a single health facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Radiation Therapy Before Surgery for Localized, Resectable Soft Tissue Sarcoma of the Extremity and Superficial Trunk

2020. "Radiation Therapy Before Surgery for Localized, Resectable Soft Tissue Sarcoma of the Extremity and Superficial Trunk". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04562480.

All > Soft Tissue Sarcoma