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 March 19, 2025
Completed
Keywords
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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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