RecruitingNot ApplicableNCT07071727

Short Course of Radiotherapy Prior to Surgery of Soft Tissue Sarcomas

Short Course Of Preoperative Radiotherapy in Head and Neck-, Trunk- and Extremity Soft Tissue Sarcomas; a Second Randomized Phase II Clinical Trial


Sponsor

The Netherlands Cancer Institute

Enrollment

150 participants

Start Date

Dec 11, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a shorter course of radiation therapy given before surgery for soft tissue sarcomas (cancers of connective tissue like fat, muscle, or nerves) in the limbs, trunk, or head and neck. The goal is to see if a shorter radiation schedule is as effective as the standard longer course while being more convenient for patients. **You may be eligible if...** - You have a confirmed intermediate to high grade soft tissue sarcoma in the limbs, trunk, chest wall, or head and neck - Your tumor is deep, 5 cm or larger, has a close expected surgical margin, or is Grade II/III - Your tumor can be surgically removed after radiation **You may NOT be eligible if...** - Your tumor is low grade or small and easily removable without radiation - Your sarcoma is located in the abdomen, pelvis, or retroperitoneum - You have already received radiation to the same area - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONPreoperative radiotherapy

preoperative radiotherapy


Locations(6)

Netherlands Cancer Institute

Amsterdam, Netherlands

AUMC

Amsterdam, Netherlands

UMCG

Groningen, Netherlands

LUMC

Leiden, Netherlands

Maastro

Maastricht, Netherlands

RadboudUMC

Nijmegen, Netherlands

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NCT07071727


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