Status:
COMPLETED
Randomised Trial of Volume of Post-operative Radiotherapy Given to Adult Patients With eXtremity Soft Tissue Sarcoma
Lead Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Conditions:
Sarcoma
Eligibility:
All Genders
16-120 years
Phase:
PHASE3
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving ...
Detailed Description
OBJECTIVES: Primary * Determine if reduced volume adjuvant radiotherapy increases limb function without compromising local control in patients with previously resected extremity soft tissue sarcoma....
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed soft tissue sarcoma meeting the following criteria:
- Lesion originates in extremity
- Upper extremity lesions may occur from the medial border of the scapula to tumors as far distal as the finger tips
- No lesions of the chest wall arising adjacent to the scapula but not originating in the shoulder bone
- Lower extremity regions include hip girdle tumors commencing at the iliac crest, excluding lesions arising from within the pelvis, and extends to include lesions as far distal as the toes
- Imaging and pathology from first surgery are required
- Has undergone surgical resection of the tumor within the past 12 weeks
- No macroscopic tumor in situ after surgery
- Microscopically irradical surgical margin allowed
- Excisional biopsy with positive margins or other inadequate surgery (macroscopically involved margins) allowed only after further definitive re-excision
- Positive margins and no further surgery possible except amputation or major functional loss allowed provided no macroscopic residual disease is present
- Local recurrence within 3 months of prior surgery (or other treatment) allowed provided patient undergoes subsequent re-excision
- No diagnosis of any of the following:
- Rhabdomyosarcoma (alveolar or embryonal)
- Primitive neuroectodermal tumor
- Soft tissue Ewing's sarcoma
- Extraskeletal osteosarcoma
- Aggressive fibromatosis (desmoid tumors)
- Dermatofibrosarcoma protuberans
- Gorlin's syndrome
- No regional nodal disease or unequivocal distant metastasis
- PATIENT CHARACTERISTICS:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- No other major medical illness that would preclude study treatment
- No other malignancy except adequately treated nonmelanomatous carcinoma of the skin or in situ carcinoma of the cervix
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior radiotherapy to the local site
- No prior neoadjuvant or adjuvant chemotherapy
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT00423618
Start Date
March 1 2006
End Date
December 31 2018
Last Update
March 18 2021
Active Locations (6)
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1
Royal Orthopedic Hospital NHS Trust
Birmingham, England, United Kingdom, B31 2AP
2
Christie Hospital
Manchester, England, United Kingdom, M20 4BX
3
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, United Kingdom, HA6 2RN
4
Nottingham City Hospital
Nottingham, England, United Kingdom, NG5 1PB