Short Course Of Preoperative Radiotherapy in Head and Neck-, Trunk- and Extremity Soft Tissue Sarcomas

Dutch title

Kortdurende pre-operatieve radiotherapie bij hoofd- en nek-, romp- en extremiteiten weke delen sarcomen

Acronym

SCOPES

Reference code

 NCT04425967

Intervention model

Randomization between the standard arm A of 50 Gy in 5 weeks or arm B with hypofractination of 14x3Gy

Full description

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.

Inclusion criteria

1. 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)
2. 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
3. WHO Performance Status ≤ 2
4. Able and willing to undergo preoperative radiotherapy
5. Able and willing to undergo definitive surgery
6. Able and willing to comply with regular follow-up visits
7. Able and willing to complete patient reported outcome questionnaires (health-related quality of life and cost effectiveness)
8. Able and willing to undergo randomization
9. Age ≥ 18 years

Exclusion criteria

1. Prior malignancies; except another malignancy and disease-free for ≥ 5 years, or completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma
2. 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)
3. Ewing sarcoma and other PNET family tumors, rhabdomyosarcomas (both pediatric and adult), osteosarcomas
4. 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
5. Female patients who are pregnant
6. Intention to perform an isolated limb perfusion, instead of a tumor resection
7. Neoadjuvant chemotherapy to be scheduled between end of radiotherapy and definitive surgery (neoadjuvant chemotherapy before radiotherapy is allowed)