Search / Trial NCT00001189

The Treatment of Grade I Sarcomas and Benign, Non-Metastasizing Highly Invasive Soft Tissue Tumors

Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 9, 2002

Trial Information

Current as of December 09, 2024

Completed

Keywords

Adjuvant Radiotherapy Low Grade Sarcoma Radiotherapy Randomized Study Sarcoma Surgery

ClinConnect Summary

This is a randomized study. Patients undergo surgical excision of all gross disease and then are randomized to Arm I or Arm II.

Arm I: Radiotherapy. Involved-field irradiation.

Arm II: No further treatment.

Gender

ALL

Eligibility criteria

  • DISEASE CHARACTERISTICS:
  • 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.

About National Cancer Institute (Nci)

The National Cancer Institute (NCI) is a prominent component of the National Institutes of Health (NIH), dedicated to advancing cancer research and improving patient outcomes through innovative clinical trials. As a leading sponsor of cancer-related studies, NCI focuses on facilitating the development of new therapies, enhancing prevention strategies, and understanding the biology of cancer. The institute collaborates with academic institutions, healthcare providers, and industry partners to conduct rigorous clinical trials that aim to translate scientific discoveries into effective treatments. NCI’s commitment to fostering a robust research environment supports the mission to eliminate cancer as a major health problem.

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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