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

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Trial Information

Current as of July 14, 2024

Completed

Keywords

Adjuvant Radiotherapy Low Grade Sarcoma Radiotherapy Randomized Study Sarcoma Surgery

Description

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.

Attachments

readout_NCT00001189_2024-07-14.pdf

4.5 MB

NCT00001189_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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