sarcoma
Conditions
Interventions
Arm A: Preoperative radiotherapy to a total dose of 42 Gy in 14 once daily fractions of 3 Gy, in an overall treatment time of three weeks. 
Arm B: Preoperative radiotherapy to a total dose of 30 Gy in 5 once daily fractions of 6 Gy, in an overall treatment time of one week.
Sponsors
Antoni van Leeuwenhoek (AVL)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Histologically confirmed newly diagnosed 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
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. (consider participation to the international Registry for MLS; https://www.avl.nl/alles-over-kanker/informatie-over-klinische-studies-trials/doremy/);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;Chemotherapy before or after radiotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| to compare the short-term toxicity of the schedule of 14 x 3 Gy, once daily fractionation in a three-week Overall Treatment Time (OTT) to 5 x 6 Gy, once daily fractionation in a one-week OTT, with respect to the rate of postoperative wound complications up to 120 days after surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| to study the association of both regimens and local control.to investigate the long-term toxicity of both regimens and to report the percentage of fibrosis, edema, joint impairment and bone fractures scored by the Common Terminology Criteria for Adverse Events, CTCAE version 5.0, at each follow-up visit.to investigate the outcome of patients that were irradiated per randomization but eventually were not operated upon in conjunction to the reasons why the operation was not executed. | — |
Countries
Netherlands, Poland
Contacts
Public ContactL.M. Wiltink
Antoni van Leeuwenhoek (AVL)
Outcome results
None listed