The Treatment of Grade I Sarcomas and Benign, Non-Metastasizing Highly Invasive Soft Tissue Tumors
NCT ID: NCT00001189
Last Updated: 2008-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
150 participants
INTERVENTIONAL
1983-12-31
2001-04-30
Brief Summary
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Detailed Description
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Arm I: Radiotherapy. Involved-field irradiation.
Arm II: No further treatment.
Conditions
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Study Design
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TREATMENT
Interventions
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radiotherapy
Eligibility Criteria
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Inclusion Criteria
Biopsy-proven grade I soft tissue sarcoma or one of the following benign but highly invasive soft tissue tumors:
Abdominal and extra-abdominal fibromatosis (desmoid,
aggressive fibromatosis),
Dermatofibrosarcoma protuberans,
Intramuscular lipoma (infiltrating lipoma),
Diffuse lipomatosis,
Leiomyoma of deep soft tissue,
Diffuse giant cell tumor of tendon sheath (proliferative synovitis).
No clinical evidence of metastases in regional nodes or more distant sites.
No primary intraperitoneal or retroperitoneal tumors.
Resection of all gross tumor at the time of surgical excision required (margins may be pathologically positive or negative).
No von Recklinghausen's disease.
PRIOR/CONCURRENT THERAPY:
Biologic Therapy: Not specified.
Chemotherapy: No prior chemotherapy for sarcoma.
Endocrine Therapy: Not specified.
Radiotherapy: No prior radiotherapy for sarcoma.
Surgery: No more than 4 months since definitive surgery for
primary lesion or recurrence.
No prior amputation.
PATIENT CHARACTERISTICS:
Age: 18 and over.
Performance status: Not specified.
Hematopoietic: Not specified.
Hepatic: No cirrhosis.
Renal: No evidence of severe renal impairment.
Cardiovascular: No ischemic heart disease.
OTHER:
No prior malignancy except basal cell carcinoma.
No serious infection.
No active bleeding disorder.
No severe concomitant disease.
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Locations
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National Cancer Institute (NCI)
Bethesda, Maryland, United States
Countries
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References
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Wara WM, Phillips TL, Hill DR, Bovill E Jr, Luk KH, Lichter AS, Leibel SA. Desmoid tumors--treatment and prognosis. Radiology. 1977 Jul;124(1):225-6. doi: 10.1148/124.1.225.
Other Identifiers
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83-C-0227
Identifier Type: -
Identifier Source: secondary_id
830227
Identifier Type: -
Identifier Source: org_study_id
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