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Short Course of Radiotherapy Prior to Surgery of Soft Tissue Sarcomas

NCT07071727 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-02-19

No results posted yet for this study

Summary

Based upon the preliminary data derived from first SCOPES clinical trial and the results of patients treated during the recent COVID-19 pandemic, patients with soft tissue sarcomas (STS) can be preoperatively irradiated in a modestly hypofractionated schedule of 14 x 3 Gy. From a toxicity and efficacy point of view, this regimen equals the outcomes after a conventionally fractionated regimen of 25 x 2 Gy in five weeks. Moreover, the rationale for investigating (modest) hypofractionation in the clinic comes both from a logistic point of view (patient convenience and a lower pressure on radiotherapy equipment), form prior phase II clinical evidence and from (cellular) radiobiological observations. There is phase II trial evidence suggesting that even more (ultra-) hypofractionation to 5 x 6 Gy is also safe and effective. Within this study, patients will be randomized to receive either the modestly hypofractionated conventional schedule of 14 x 3 Gy or an even shorter preoperative regimen of 5 x 6 Gy, in the hypothesis that both the postoperative wound complication rate until 120 days after surgery, as well as the local control probability at two years are comparable in both arms.

Conditions

  • Sarcoma of Soft Tissue
  • Sarcoma
  • Sarcoma, Soft Tissue

Interventions

RADIATION

Preoperative radiotherapy

preoperative radiotherapy

Sponsors & Collaborators

  • Radboud University Medical Center

    collaborator OTHER

  • University Medical Center Groningen

    collaborator OTHER

  • Leiden University Medical Center

    collaborator OTHER

  • Amsterdam UMC

    collaborator OTHER

  • Maastro Clinic, The Netherlands

    collaborator OTHER

  • The Netherlands Cancer Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-11
Primary Completion
2028-11-01
Completion
2033-11-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07071727 on ClinicalTrials.gov