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

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt-Ingram Cancer Center
Study ID
NCT04506008
Phase
PHASE2
Status
Recruiting
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Conditions

  • Soft Tissue Sarcomas

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ultra-Hypo-fractionation Radiotherapy — RADIATION
    Five fractions of pre-operative radiation
  • Resection — PROCEDURE
    Surgery
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Moderately-Hypo-fractionation Radiotherapy — RADIATION
    15 fractions of pre-operative radiation

Study Details

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.

Key Dates

First listed
Aug 10, 2020
Start date
Mar 2, 2021
Status verified
Mar 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Group I (UH HRT)
    Patients undergo HRT daily for a total of 5 fractions followed by surgery.
  • Experimental: Group II (MH HRT)
    Patients undergo HRT daily for a total of 15 fractions followed by surgery.

Primary Outcome Measure

Local control rate [ Time Frame: Approximately 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232
Vanderbilt-Ingram Service for Timely Access
[email protected]
800-811-8480
Eric Shinohara, MD (PRINCIPAL_INVESTIGATOR)

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Vanderbilt-Ingram Cancer Center· Nashville, TN

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