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NCT Number: NCT04506008

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

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.

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Key information

Conditions

Soft Tissue Sarcomas Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Sarcoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location status: Recruiting

Location contact

Eric Shinohara, MD

PRINCIPAL_INVESTIGATOR

Vanderbilt-Ingram Service for Timely Access

CONTACT

[email protected]

800-811-8480

About this study

Study Objectives:

Primary:

  • To investigate the efficacy of neoadjuvant hypo-fractionated radiotherapy (HRT) followed by surgical resection in the treatment of soft tissue sarcoma (STS) as measured by local control
  • Examine the side effect profile using Radiation Therapy Oncology Group (RTOG) and Common Terminology Criteria for Adverse Events (CTCAE) acute and late side effects criteria and major and minor post-operative complication rates.

OUTLINE: Patients are assigned to 1 of 2 groups by the radiation oncologist.

GROUP I (ULTRA-HYPOFRACTIONATION [UH]): Patients undergo HRT daily for a total of 5 fractions followed by surgery.

GROUP II (MODERATE HYPOFRACTIONATION [MH]): Patients undergo HRT daily for a total of 15 fractions followed by surgery.

After completion of study treatment, patients are followed up within 3 months, then every 3-6 months for a minimum of 2 years.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologic diagnosis of a soft tissue sarcoma of extremity, pelvis, chest wall or trunk/abdominal wall (non-retroperitoneal location)
  • ECOG performance status 0-2
  • Patient must be deemed able to comply with radiation treatment and surgery

Exclusion criteria

  • History of prior radiation to the same area to be irradiated
  • Pregnancy
  • Active collagen vascular disease or patients genetically predisposed to increased radiation related side effects

Treatment and study plan

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

Primary outcomes

  1. Local control rate

    Time frame: Approximately 2 years

    Will be estimated with a Beta-Binomial model with Beta(0.5, 0.5) as the prior distribution. The median and a 95% credible interval of the posterior distribution will be reported.

Secondary outcomes

  1. Complication rate

    Time frame: Approximately 2 years

    The complication rate will be modeled with a Beta-Binomial model with Beta(0.5, 0.5) as the prior distribution, and it will be monitored continuously throughout the study. The complication rate will also be modeled with a Beta-Binomial model with Beta(0.5, 0.5) as the prior distribution, and it will be monitored continuously throughout the study.

Study contacts

Contact information is provided by the study sponsor or research team.

Vanderbilt-Ingram Service for Timely Access

CONTACT

[email protected]

800-811-8480

Sponsors and collaborators

Lead sponsor

Vanderbilt-Ingram Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Aug 10, 2020
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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