Short-course radiotherapy before surgery for soft tissue sarcoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with localized intermediate- to high-grade soft tissue sarcoma who are planned for combined radiotherapy and surgery are randomized to receive either a modestly hypofractionated preoperative schedule (14 x 3 Gy) or an even shorter preoperative regimen. The trial builds on prior phase II data, preliminary SCOPES results, and COVID-era treatment experience suggesting comparable toxicity and efficacy to conventional fractionation. Key entry requirements include tumor depth/size or grade criteria, no regional or distant metastases, and fitness for radiotherapy and definitive surgery. Participants will be followed for surgical outcomes, toxicity, patient-reported quality of life, and resource use.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically confirmed intermediate to high grade soft tissue sarcoma localized to the head and neck area, to the trunk and chest wall or to the extremities, for which the standard treatment is a combination of and radiotherapy and surgery (deep seated and/or ≥ 5cm in largest tumor diameter and/or an anticipated close resection margin and/or grade II/III according to the FNCLCC definition);
* Absence of regional and/or distant disease. Patients must be staged by at least a CT scan of the chest. Staging may also be performed by FDG-PET scanning and/or total body MRI scans;
* WHO Performance Status ≤ 2;
* Able and willing to undergo preoperative radiotherapy;
* Able and willing to undergo definitive surgery;
* Able and willing to comply with regular follow-up visits;
* Able and willing to complete patient reported outcome questionnaires (health-related quality of life and cost effectiveness);
* Able and willing to undergo randomization;
* Age ≥ 18 years;
* Signed written informed consent.

Exclusion Criteria:

* Prior malignancies; except another malignancy and disease-free for ≥ 5 years, or completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma;
* Patients with locally recurrent sarcomas, regardless of the management of the first sarcoma diagnosis;
* Ewing sarcoma and other PNET family tumors, rhabdomyosarcomas (both pediatric and adult), osteosarcomas;
* Myxoid liposarcomas, because they have shown to be exquisitely sensitive to a lower dose of radiation as compared to the 2 regimens tested in this trial.
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial;
* Female patients who are pregnant;
* Intention to perform an isolated limb perfusion, instead of a tumor resection;
* Neoadjuvant chemotherapy both before and after radiotherapy.

Where it's running

• Aumc
  Amsterdam, Netherlands Recruiting
• Maastro
  Maastricht, Netherlands Recruiting
• Netherlands Cancer Institute
  Amsterdam, Netherlands Not yet recruiting
• Umcg
  Groningen, Netherlands Not yet recruiting
• Lumc
  Leiden, Netherlands Not yet recruiting
• RadboudUMC
  Nijmegen, Netherlands Not yet recruiting

Study contacts

• Study coordinator: Lisette M Wiltink, MD, PhD
• Email: l.m.wiltink@lumc.nl
• Phone: +31205129111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.