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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
Tumor located in the soft tissues of the extremities or superficial trunk
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 120 days after radiation therapy
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 belowSelect...
I can take care of myself but can't do heavy physical work.
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My tumor is in the soft tissue of my limbs or upper body.
Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 120 days after radiation therapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 120 days after radiation therapy
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 moreSide effects data
From 2023 Phase 3 trial • 107 Patients • NCT0332480280%
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 3
~130
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,976 Previous Clinical Trials
1,789,386 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,687 Previous Clinical Trials
40,930,249 Total Patients Enrolled
Beverly A GuadagnoloPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had a biopsy that might not have removed all cancer, but further surgery is advised.I can take care of myself but can't do heavy physical work.I've had radiation therapy before on the same area where my sarcoma is now.My tumor is in the soft tissue of my limbs or upper body.My cancer has not spread to lymph nodes or other parts of my body.I am currently pregnant.My cancer is a type of sarcoma that started in my soft tissues.My sarcoma can be fully removed by surgery.My cancer has spread to lymph nodes or other parts of my body.You are expected to live for at least 6 more months.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (hypofractionated RT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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