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Radiation

Short-course Radiation Therapy for Sarcoma

N/A

Recruiting

Led By Mitchell Kamrava

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

Histologically confirmed soft tissue sarcoma of the extremity/trunk

Recurrent sarcoma, any grade, no previous radiation therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial looks at the side effects of a higher dose of radiation therapy given over a shorter period of time for patients with soft tissue sarcomas.

Who is the study for?

This trial is for adults with a certain type of cancer called soft tissue sarcoma in the limbs or trunk. They should be relatively active and healthy (KPS >= 70 or ECOG 0-2), not pregnant if female, and have a tumor that can be surgically removed. Those with recurring cancer are eligible if they haven't had radiation before; however, people actively treating another cancer or who've had pre-op chemo aren't.Check my eligibility

What is being tested?

The study tests hypofractionated radiation therapy given over five days before surgery for soft tissue sarcomas. This approach uses higher doses in fewer sessions compared to traditional radiation, aiming to kill more tumor cells while potentially causing fewer side effects.See study design

What are the potential side effects?

Potential side effects may include skin irritation, fatigue, swelling at the treatment site, and possible damage to nearby tissues or organs due to high-dose radiation exposure. The exact side effects will vary from person to person.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is a type of sarcoma found in my limbs or trunk.

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My sarcoma has come back and I haven't had radiation before.

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I can care for myself and perform normal activities.

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My sarcoma is not low grade.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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

Grade >= 2 radiation morbidity (subcutaneous tissue fibrosis, joint stiffness, or edema)

Secondary outcome measures

Distant metastasis

Local anesthesia

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: Treatment (hypofractionated radiation therapy)Experimental Treatment4 Interventions

Patients undergo hypofractionated radiation therapy on Monday-Friday for 5 days. Beginning 2-12 weeks after completion of radiation therapy, patients undergo surgery.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Conventional Surgery

2006

Completed Phase 3

~1080

Hypofractionated Radiation Therapy

2016

Completed Phase 2

~130

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Radiological Society of North AmericaOTHER

25 Previous Clinical Trials

1,768 Total Patients Enrolled

Sarcoma Alliance for Research through CollaborationOTHER

25 Previous Clinical Trials

1,903 Total Patients Enrolled

Tower Cancer Research FoundationUNKNOWN

2 Previous Clinical Trials

47 Total Patients Enrolled

Media Library

$Hypofractionated Radiation Therapy (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT02701153 — N/A$

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

$Adult Soft Tissue Sarcoma Clinical Trial 2023: Hypofractionated Radiation Therapy Highlights & Side Effects. Trial Name: NCT02701153 — N/A$

$Hypofractionated Radiation Therapy (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02701153 — N/A$

Frequently Asked Questions

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

What is the current enrollment rate of this research program?

"Affirmative. According to clinicaltrials.gov, this research trial is still searching for participants. The first posting was on February 3rd 2016 and the most recent update occurred on March 2nd 2022. 51 people are needed at a single medical center."

Answered by AI

Are recruitment efforts ongoing for this research endeavor?

"As indicated on clinicaltrials.gov, this medical trial is currently accepting applicants; the initial posting was made on February 3rd 2016 and revised March 2nd 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase II Study of 5-Day Hypofractionated Preoperative Radiation Therapy for Soft Tissue Sarcomas: Expansion Cohort

2016. "Phase II Study of 5-Day Hypofractionated Preoperative Radiation Therapy for Soft Tissue Sarcomas: Expansion Cohort". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02701153.

All > Soft Tissue Sarcoma