NCT04425967Active, not recruiting
Short Course Of Preoperative Radiotherapy in Head and Neck-, Trunk- and Extremity Soft Tissue Sarcomas
Short Course Of Preoperative Radiotherapy in Head and Neck-, Trunk- and Extremity Soft Tissue Sarcomas; a Randomized Phase II Clinical Trial
Source: ClinicalTrials.gov · Last updated 17 Sept 2026
Brief summary (registry, in English)
Currently, soft tissue sarcomas (STS) are preoperatively irradiated in a conventionally fractionated regimen of 25 x 2 Gy in five weeks. Recent radiobiological investigations, however, suggest sensitivity to (modest) hypofractionation. Within this study, patients will be randomized to receive either the conventional schedule of 25 x 2 Gy or a shorter preoperative regimen of 14 x 3 Gy, in the hypothesis that both the postoperative wound complication rate until 30 days after surgery, as well as the local control probability at two years are comparable in both arms.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 168 (actual)
- First submitted
- 3 Jun 2020
- Start date
- 25 Jun 2021
- Primary completion date
- 13 May 2026
- Lead sponsor
- The Netherlands Cancer Institute
- Diseases
- Sarcoma
- NCT number
- NCT04425967
What you commit to
- Study type: Interventional
- Participants enrolled: 168
- From 25 Jun 2021 to the primary completion date, 13 May 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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);
- 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);
Other illness
- 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;
Age
- Prior malignancies; except another malignancy and disease-free for ≥ 5 years, or completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma;
Other
- Ewing sarcoma and other PNET family tumors, rhabdomyosarcomas (both pediatric and adult), osteosarcomas;
- Female patients who are pregnant;
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitair Medisch Centrum Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Unknown status |
| Leids Universitair Medisch Centrum Coordinator of this site? Confirm its status | Leiden | Netherlands | Unknown status |
| Radboudumc Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
| Erasmus Medical Centre Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.