Could a shorter radiation zap before surgery be just as good for sarcoma patients?
NCT ID NCT04425967
First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 2 times
Summary
This study compares the usual 5-week radiation schedule before sarcoma surgery to a shorter 2-week course. Researchers want to see if the shorter course leads to similar wound healing and tumor control. About 168 adults with soft tissue sarcomas in the head, neck, trunk, or limbs are taking part.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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168 people
The number who actually took part.
- Started
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Jun 2021
- Expected to finish
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May 2036
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically confirmed newly diagnosed intermediate to high grade soft tissue sarcoma localized to the extremities, trunk and chest wall or the head and neck area, 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 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. Patients with an uncertain metastatic status (e.g. small indifferent lung nodules) and patients with a low metastatic burden not precluding the application of both preoperative radiotherapy and definitive surgery, are allowed to participate; * 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 recurrent sarcomas who underwent prior radiotherapy to the target lesion (if the primary sarcoma was managed by surgery only and no perioperative RT, patients are eligible); * Ewing sarcoma and other PNET family tumors, rhabdomyosarcomas (both pediatric and adult), osteosarcomas; * 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 to be scheduled between end of radiotherapy and definitive surgery (neoadjuvant chemotherapy before radiotherapy is allowed);
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Erasmus Medical Centre
Rotterdam, Netherlands
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Leids Universitair Medisch Centrum
Leiden, 2333ZA, Netherlands
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Radboudumc
Nijmegen, 6525GA, Netherlands
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Universitair Medisch Centrum Groningen
Groningen, 9713GZ, Netherlands
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