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

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

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

• Vanderbilt-Ingram Service for Timely Access
  800-811-8480
  [email protected]

Locations (1)

Find similar trials in Nashville, TN

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  PHASE1 · Not Yet Recruiting · M.D. Anderson Cancer Center · Houston, Texas