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NCT Number: NCT06087861

5-Day Preoperative Radiation for Soft Tissue Sarcoma

The purpose of this study is to examine the safety and efficacy of an abbreviated course of preoperative radiation, given over five days, for patients with soft tissue sarcoma of the extremity, trunk or retroperitoneum. This is in contrast to standard preoperative radiation, which is given over 25 days.

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Key information

Conditions

Soft Tissue Sarcoma 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

Stanford University

Palo Alto, California, 94305, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically confirmed soft tissue sarcoma of the extremity, trunk or retroperitoneum.
  • Has been offered preoperative radiation and surgery as part of standard-of-care treatment
  • Age ≥ 18
  • KPS ≥ 70 or ECOG 0 to 2
  • Life expectancy ≥ 6 months
  • If a woman is of childbearing potential, a negative serum or urine pregnancy test must be documented.
  • Ability to understand and the willingness to personally sign the written IRB approved informed consent document.

Exclusion criteria

  • History of prior radiation to the area to be treated.
  • Active use of other anti-cancer investigational agents.
  • Planned use of concurrent chemotherapy, targeted therapy, or immunotherapy with radiation therapy (defined as the time interval starting 1 week before the first and last fraction of radiation therapy and surgery).
  • Pregnancy.

Treatment and study plan

External Beam Radiotherapy

Radiation

Radiation will be delivered by external beam techniques to the tumor and areas of possible microscopic disease at a dose of 30 Gy divided into 5 equal fractions of 6 Gy (administered over a total of 5 to 10 business day

Primary outcomes

  1. Post-operative Complication Rate

    Time frame: 120 days after surgery

    Rate of post-operative complications.

Secondary outcomes

  1. Local Recurrence Rate

    Time frame: 2 years and 5 years after surgical resection

    Rate of local recurrence, including in-field, borderline and out-field recurrences

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Phase 2 5-Day Preoperative Radiation for Soft Tissue Sarcoma

Important dates

Study start
2023
Primary completion
2027
Study completion
2029
First posted
Oct 18, 2023
Registry last updated
Jun 10, 2026

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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