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Radiation

Hypofractionated Radiation Therapy for Soft Tissue Sarcoma

Phase 2
Waitlist Available
Led By Beverly A Guadagnolo
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 3 or less
Patient may have had excisional biopsy of all gross disease at an outside facility with positive or uncertain resection margins and still be eligible if the evaluating sarcoma surgeon in the participating institution recommends oncologic re-resection of the surgical bed to obtain negative margins after a course of neoadjuvant irradiation (a sandwich approach of marginal excision-->radiation therapy(RT)--> wide excision, as per our standard practice)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 120 days after surgery
Awards & highlights

Study Summary

This trial looks at the risk of wound complications from shorter, more convenient radiation therapy for patients with localized soft tissue sarcoma.

Who is the study for?
This trial is for adults with localized soft tissue sarcoma in limbs or superficial trunk, who can undergo surgery and have no distant cancer spread. They must be able to follow up, use contraception if capable of childbearing, and have a life expectancy over 6 months. Those previously treated with radiation at the same site or pregnant women are excluded.Check my eligibility
What is being tested?
The study tests a shorter course of high-dose radiation therapy before surgery compared to traditional longer courses. It aims to see if this approach reduces tumor cells effectively while causing fewer side effects and complications during wound healing.See study design
What are the potential side effects?
Potential side effects may include skin irritation, fatigue, swelling in treated areas, and possible delayed wound healing due to the higher doses of radiation given over a short time frame.

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 but can't do heavy physical work.
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I had a biopsy that might not have removed all cancer, but further surgery is advised.
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My tumor is in the soft tissue of my limbs or upper body.
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My cancer has not spread to lymph nodes or other parts of my body.
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My cancer is a type of sarcoma that started in my soft tissues.
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My sarcoma can be fully removed by surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 120 days after radiation therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 120 days after 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
Time to a major wound complication (MWC)
Secondary outcome measures
Disease free survival (DFS) time
Disease specific survival time
Functional outcomes
+6 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
7%
Skin hypopigmentation
6%
Edema limbs
2%
Device related infection
100%
80%
60%
40%
20%
0%
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 RT)Experimental Treatment3 Interventions
Patients receive hypofractionated radiation therapy in 15 daily fractions over 3 weeks in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hypofractionated Radiation Therapy
2016
Completed Phase 2
~130

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,217 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,603 Previous Clinical Trials
40,913,153 Total Patients Enrolled
Beverly A GuadagnoloPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Hypofractionated Radiation Therapy (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT03819985 — Phase 2
Soft Tissue Sarcoma Research Study Groups: Treatment (hypofractionated RT)
Soft Tissue Sarcoma Clinical Trial 2023: Hypofractionated Radiation Therapy Highlights & Side Effects. Trial Name: NCT03819985 — Phase 2
Hypofractionated Radiation Therapy (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03819985 — Phase 2

Frequently Asked Questions

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

Has Hypofractionated Radiation Therapy undergone testing by the FDA?

"Hypofractionated Radiation Therapy, while having some evidence backing its safety, is only in Phase 2 of clinical trials. This means that, currently, there is no data supporting its efficacy."

Answered by AI

Are there any unfilled positions in this research project?

"This study, which was originally posted on December 17th 2018 and last updated on August 22nd 2022, is not currently seeking participants. However, there are 460 other clinical trials that are presently looking for candidates."

Answered by AI
~9 spots leftby Aug 2024