Recruiting nowN/AAges 18 Years and up
Short Course of Radiotherapy Prior to Surgery of Soft Tissue Sarcomas
Sponsor: The Netherlands Cancer Institute · NCT07071727 on ClinicalTrials.gov ↗
Conditions studied
Sarcoma of Soft TissueSarcomaSarcoma, Soft Tissue
What it tests
- Preoperative radiotherapyradiation
Where it's running6 sites
6 international sites
- Opening soon
Netherlands Cancer Institute
Amsterdam, Netherlands 2141NK
- L M Wiltink, MD PhD(contact)0205129111[email protected]
- Recruiting now
AUMC
Amsterdam, Netherlands
- Balgobind(contact)+31 20 5669111[email protected]
- Opening soon
UMCG
Groningen, Netherlands
- Ubbels(contact)+31 50 361 6161[email protected]
- Opening soon
LUMC
Leiden, Netherlands
- Krol(contact)+31 71 526 9111[email protected]
- Recruiting now
Maastro
Maastricht, Netherlands
- Wesseling(contact)+31884455600[email protected]
- Opening soon
RadboudUMC
Nijmegen, Netherlands
- Braam(contact)+3124 361 11 11[email protected]
See the official eligibility language
Shown exactly as written on ClinicalTrials.gov. Your oncologist is the right person to judge whether it fits your situation.
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.
Updated 2026-02-19 on ClinicalTrials.gov. Always confirm current details with the study team or your oncologist.