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Radiation Therapy

Hypofractionated Radiation Therapy for Soft Tissue Sarcoma

N/A

Waitlist Available

Led By Meena Bedi, MD

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

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

Must have

Karnofsky Performance Status (KPS) 60 or above

No prior radiotherapy to primary site or adjacent site that results in overlapping radiation fields.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing if a new way of giving radiation to people with a certain kind of cancer is feasible, has minimal side effects, and helps control the cancer.

Who is the study for?

This trial is for adults over 18 with Stage I-III Soft Tissue Sarcoma in the limbs or chest-wall, without metastatic disease. Participants must be medically operable, have a performance status score of 60 or above, and not have had prior radiotherapy where fields overlap. Pregnant women and those unable to undergo MRI are excluded.Check my eligibility

What is being tested?

The study tests hypofractionated preoperative radiation therapy's safety and effectiveness on local tumor control and survival rates in patients with localized soft tissue sarcomas. It's a Phase II pilot trial that isn't randomized.See study design

What are the potential side effects?

Potential side effects may include skin changes, fatigue, swelling at the treatment site, pain or discomfort during treatment sessions. Long-term effects can vary but might involve changes to bone or muscle tissue.

Eligibility Criteria

Inclusion Criteria

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

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I can care for myself but may need occasional help.

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I haven't had radiation therapy on or near the primary cancer site.

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I have had a core needle biopsy.

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My sarcoma is in an arm or leg and hasn't spread to other body parts.

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My cancer is a confirmed soft tissue sarcoma in my arm, leg, or chest-wall.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 Disease Control Assessed by Magnetic Resonance Imaging (MRI)

Local Disease Control Assessed by Physical Examination

Secondary outcome measures

Disease-free Survival

Musculoskeletal Tumor Rating Scale (MSTS) Score

Overall Survival

+2 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: Hypofractionated Radiation TherapyExperimental Treatment1 Intervention

Radiation treatment in which the total dose of radiation is divided into large doses and treatments are given every other day. Hypofractionated radiation therapy is given over a shorter period of time (fewer days or weeks) than standard radiation therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hypofractionated Radiation Therapy

2016

Completed Phase 2

~130

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor

609 Previous Clinical Trials

1,162,566 Total Patients Enrolled

Meena Bedi, MDPrincipal InvestigatorMedical College of Wisconsin

Media Library

$Hypofractionated Radiation Therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02634710 — N/A$

$Soft Tissue Sarcoma Research Study Groups: Hypofractionated Radiation Therapy$

$Soft Tissue Sarcoma Clinical Trial 2023: Hypofractionated Radiation Therapy Highlights & Side Effects. Trial Name: NCT02634710 — N/A$

$Hypofractionated Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02634710 — N/A$

Frequently Asked Questions

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

What outcomes is this clinical trial attempting to accomplish?

"This two-year trial will measure the local disease control of patients as evaluated by MRI, pathologic changes due to hypofractionated radiation, disease-free survival over a 24 month period and an assessment of toxicity using the Musculoskeletal Tumor Rating Scale. The MSTS evaluates pain, functionality, emotional acceptance, hand positioning, dexterity and lifting ability on a six item Likert scale from 0 (worst condition) to 5 (best condition)."

Answered by AI

Does this experiment have open enrollment for participants?

"As indicated on clinicaltrials.gov, the recruitment period of this medical study has closed as it was last updated March 23rd 2022. Even so, there are 446 other trials searching for test subjects."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Hypofractionated Pre-operative Radiation Therapy for Soft Tissue Sarcomas of the Extremity and Chest-wall

Meena Bedi 2016. "Hypofractionated Pre-operative Radiation Therapy for Soft Tissue Sarcomas of the Extremity and Chest-wall". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02634710.

All > Soft Tissue Sarcoma