Extremity soft tissue sarcoma Cancer Sarcoma
Conditions
Interventions
Patients will have a number of baseline assessments prior to surgery, including:
1. History
2. Physical examination
3. Performance status
Sponsors
University of Sheffield (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically proven soft tissue sarcoma. Imaging and pathology from first surgery are required. 2. Lesion originates in extremity. For upper extremity this includes lesions from the medial border of the scapula to tumours as far distal as the finger tips. It does not include lesions of the chest wall arising adjacent to the scapula but not originating in the shoulder bone. The lower extremity regions include hip girdle tumours commencing at the iliac crest, excluding lesions arising from within the pelvis, and extends to include lesions as far distal as the toes. 3. The patients who have undergone excisional biopsy with positive margins or other inadequate surgery (macroscopically involved margins) will be eligible for entry into this study only following further definitive re-excision. A microscopically irradical surgical margin is permitted but not a macroscopically involved one. Patients with positive margins in whom no further surgery is possible short of amputation or major functional loss may be included provided there is no macroscopic residual disease. 4. Patient has been evaluated by the surgeon and radiotherapist, who agree that a combination of the two treatments is appropriate and that the patient is fit for protocol therapy 5. No prior radiotherapy to the local site 6. Signed and dated Patient Informed Consent 7. Protocol treatment is to begin within 12 weeks of surgery 8. Patient must be 16 years of age or older
Exclusion criteria
Exclusion criteria: 1. Patient has rhabdomyosarcoma of the alveolar or embryonal subcategories, primitive neuro-ectodermal tumour (PNET) soft tissue Ewing?s sarcoma, extraskeletal osteosarcoma, aggressive fibromatosis (desmoid tumours) or dermatofibrosarcoma protruberans 2. Patients with local recurrence after previous treatment of a sarcoma are excluded (as they have a significantly higher risk of late recurrence) 3. Prior or concurrent malignancy except adequately treated non-melanomatous carcinoma of the skin or in situ carcinoma of the cervix 4. Stage of disease such that limb conservation treatment by a combination of surgery and radiotherapy is not appropriate 5. The surgery performed has left macroscopic tumour in situ 6. Use of neoadjuvant or adjuvant chemotherapy 7. Patient has regional nodal disease or unequivocal distant metastasis 8. Other major medical illness judged likely by the local investigator to preclude safe administration of protocol treatment 9. Local recurrence more than 3 months after previous definitive surgery (patients with local recurrence within 3 months of previous surgery and who undergo subsequent re-excision may be included as they are considered to have initial inadequate primary excision)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Limb functionality: as measured by the Toronto Extremity Salvage Score (TESS) 2. Time to local recurrence: defined in whole days, as the time from randomisation into the trial to the occasion when a biopsy-confirmed local recurrence is first suspected by clinical examination; for those patients who are not observed to have a local relapse during the course of the study, the time to local recurrence will be censored at the last follow-up date 3. Local recurrence rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Soft tissue and bone toxicity: measured by the RTOG scoring system 2. Disease-free survival time: defined in whole days as time from randomisation into the trial to either local or distant recurrence or death (whichever occurs first) 3. Overall survival time: defined in whole days as time from randomisation into the trial to death | — |
Countries
England, Scotland, United Kingdom
Outcome results
None listed