Search / Trial NCT00002459

Radiation Therapy or No Further Treatment Following Surgery in Treating Patients With Cancer of the Uterus

Launched by EUROPEAN ORGANISATION FOR RESEARCH AND TREATMENT OF CANCER - EORTC · Mar 10, 2004

Trial Information

Current as of December 27, 2024

Completed

Keywords

Stage I Uterine Sarcoma Stage Ii Uterine Sarcoma Uterine Carcinosarcoma Uterine Leiomyosarcoma Endometrial Stromal Sarcoma

ClinConnect Summary

OBJECTIVES: I. Compare the rates of pelvic recurrence and development of distant metastases in patients with completely resected, stage I or II, high-grade uterine sarcoma treated with adjuvant pelvic radiotherapy vs observation alone.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, tumor histology (leiomyosarcoma vs mixed mesodermal sarcoma vs endometrial stromal sarcoma), and surgical procedure (total abdominal hysterectomy (TAH) with or without bilateral salpingo-oophorectomy (BSO) vs TAH and BSO with pelvic and para-aortic node sampling an...

Gender

FEMALE

Eligibility criteria

  • DISEASE CHARACTERISTICS: Histologically proven high-grade uterine sarcoma Eligible subtypes: Leiomyosarcoma Mixed mesodermal (mullerian) sarcoma Endometrial sarcoma Surgically proven stage I or II (T1-2, N0, M0) disease No leiomyoma with a high mitotic activity index after hormonal therapy (especially estrogen) Mixoid leiomyosarcoma with a low mitotic activity index allowed Completely resected disease Prior abdominal hysterectomy as minimal surgical procedure required
  • PATIENT CHARACTERISTICS: Age: Any age Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix No serious mental disorder
  • PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: See Disease Characteristics Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics

Trial Officials

Sergio L. Pecorelli, MD

Study Chair

Spedali Civili di Brescia

Gavin C.E. Stuart, MD

Study Chair

Tom Baker Cancer Centre - Calgary

About European Organisation For Research And Treatment Of Cancer Eortc

The European Organisation for Research and Treatment of Cancer (EORTC) is a prominent non-profit organization dedicated to advancing cancer research and improving patient care through innovative clinical trials. Established in 1962, EORTC fosters collaboration among international researchers, healthcare professionals, and institutions to develop and implement rigorous clinical studies that evaluate novel therapies and treatment strategies. With a strong commitment to enhancing the quality of life for cancer patients, EORTC focuses on multidisciplinary approaches and the integration of patient-reported outcomes, ensuring that its findings translate effectively into clinical practice and contribute to the global fight against cancer.

Locations

Leuven, , Belgium

Calgary, Alberta, Canada

Fleurimont, Quebec, Canada

Rouen, , France

Brescia, , Italy

Milano, , Italy

Milan, , Italy

Monza, , Italy

Padova, , Italy

Pavia, , Italy

Varese, , Italy

Voghera (Pv), , Italy

Amsterdam, , Netherlands

Amsterdam, , Netherlands

Enschede, , Netherlands

Heerlen, , Netherlands

Maastricht, , Netherlands

Nijmegen, , Netherlands

Rotterdam, , Netherlands

Rotterdam, , Netherlands

Utrecht, , Netherlands

Gdansk, , Poland

Valencia, , Spain

Linkoping, , Sweden

Stockholm, , Sweden

Geneva, , Switzerland

Derby, England, United Kingdom

Glasgow, Scotland, United Kingdom

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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