Status:
RECRUITING
Short Course Of Preoperative Radiotherapy in Head and Neck-, Trunk- and Extremity Soft Tissue Sarcomas
Lead Sponsor:
The Netherlands Cancer Institute
Collaborating Sponsors:
Leiden University Medical Center
Conditions:
Soft Tissue Sarcomas
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 sensiti...
Detailed Description
Surgery is the cornerstone in the treatment of non-metastatic sarcomas. Whenever feasible the resection should include a free surgical margin providing a rim of uninvolved tissue surrounding the tumor...
Eligibility Criteria
Inclusion
- 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
- 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);
Key Trial Info
Start Date :
June 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2031
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT04425967
Start Date
June 25 2021
End Date
May 1 2031
Last Update
June 24 2025
Active Locations (4)
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1
Universitair Medisch Centrum Groningen
Groningen, Netherlands, 9713GZ
2
Leids Universitair Medisch Centrum
Leiden, Netherlands, 2333ZA
3
Radboudumc
Nijmegen, Netherlands, 6525GA
4
Erasmus Medical Centre
Rotterdam, Netherlands