RecruitingPhase 2NCT04506008

Hypofractionated Radiotherapy Followed by Surgical Resection in the Treatment of Soft Tissue Sarcomas

Prospective Observational Trial of Two Neoadjuvant Hypofractionated Radiotherapy Regimens Followed by Surgical Resection in the Treatment of Soft Tissue Sarcomas


Sponsor

Vanderbilt-Ingram Cancer Center

Enrollment

40 participants

Start Date

Mar 2, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

The trial will use neoadjuvant hypofractionated radiotherapy followed by surgical resection in the treatment for soft tissue sarcoma. It will allow patients to be treated over a shorter course (5 or 15 days of radiation) compared to the traditional 5 week regimen. It is proposed that this will be possible without increasing the risk of wound complication or local recurrence compared with a traditional 5 week course of pre-operative radiation.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether giving a concentrated course of radiation therapy (hypofractionated radiotherapy) before surgery improves outcomes for people with soft tissue sarcoma — a type of cancer that grows in muscles, fat, nerves, or connective tissue — in the limbs, pelvis, chest wall, or trunk. **You may be eligible if...** - You have been diagnosed with soft tissue sarcoma of the arm, leg, pelvis, chest wall, or trunk (not in the abdomen/retroperitoneum) - You are well enough to tolerate radiation and surgery (ECOG status 0–2) - Your medical team has determined surgery is possible **You may NOT be eligible if...** - You have had prior radiation to the same area - You are pregnant - You have active collagen vascular disease (such as lupus or scleroderma) - Your sarcoma is in the retroperitoneum (back of the abdomen) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONUltra-Hypo-fractionation Radiotherapy

Five fractions of pre-operative radiation

PROCEDUREResection

Surgery

OTHERQuestionnaire Administration

Ancillary studies

RADIATIONModerately-Hypo-fractionation Radiotherapy

15 fractions of pre-operative radiation


Locations(1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

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NCT04506008


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