RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether receiving radiation therapy or no further therapy after surgery is more effective for cancer of the uterus. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with that of no further therapy in treating patients who have stage I or stage II cancer of the uterus that has been surgically removed.

Condition	Treatment or Intervention	Phase
uterine leiomyosarcoma uterine carcinosarcoma stage II uterine sarcoma Endometrial Stromal Sarcoma stage I uterine sarcoma	Procedure: Radiation therapy	Phase III

Further Study Details: 

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.

PROTOCOL 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 and random biopsies). Patients are randomized to 1 of 2 treatment arms. Arm I: Beginning within 6 weeks after surgery, patients undergo pelvic radiotherapy 5 days a week for 5.6 weeks. Arm II: Patients undergo observation alone. Patients are followed every 2 months for 1 year, every 3 months for 2 years, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 200 patients (100 per arm) will be accrued for this study within 3 years.

Criteria

PROTOCOL ENTRY 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

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: Not specified
• Endocrine therapy: See Disease Characteristics
• Radiotherapy: No prior radiotherapy
• Surgery: See Disease Characteristics

--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

Belgium
      U.Z. Gasthuisberg, Leuven,  B-3000,  Belgium
Canada, Alberta
      Tom Baker Cancer Center - Calgary, Calgary,  Alberta,  T2N 4N2,  Canada
Canada, Quebec
      CHUS-Hopital Fleurimont, Fleurimont,  Quebec,  J1H 5N4,  Canada
France
      Centre Henri Becquerel, Rouen,  76038,  France
Italy
      I.R.C.C.S. Policlinico San Matteo, Pavia,  27100,  Italy
      Istituto Nazionale per lo Studio e la Cura dei Tumori, Milan,  20133,  Italy
      Istituto Scientifico H.S. Raffaele, Milano,  20132,  Italy
      Ospedale Civile, Voghera (PV),  27058,  Italy
      Ospedale di Circolo e Fondazione Macchi, Varese,  21100,  Italy
      Ospedale San Gerardo, Monza,  20052,  Italy
      Spedali Civili, Brescia,  25124,  Italy
      Universita di Padova, Padova,  35128,  Italy
Netherlands
      Academisch Ziekenhuis Maastricht, Maastricht,  6202 AZ,  Netherlands
      Academisch Ziekenhuis Utrecht, Utrecht,  3508 GA,  Netherlands
      Antoni van Leeuwenhoekhuis, Amsterdam,  1066 CX,  Netherlands
      Atrium Medical Centre, HEERLEN,  6419 PC,  Netherlands
      Medisch Spectrum Twente, ENSCHEDE,  7500 KA,  Netherlands
      Rotterdam Cancer Institute, Rotterdam,  3075 EA,  Netherlands
      University Hospital - Rotterdam Dijkzigt, Rotterdam,  3000 CA,  Netherlands
      University Medical Center Nijmegen, Nijmegen,  NL-6252 HB,  Netherlands
      Vrije Universiteit Medisch Centrum, Amsterdam,  1001HV,  Netherlands
Poland
      Medical University of Gdansk, Gdansk,  80-211,  Poland
Spain
      Instituto Valenciano De Oncologia, Valencia,  46009,  Spain
Sweden
      Karolinska Hospital, Stockholm,  S-171 76,  Sweden
      University Hospital of Linkoping, Linkoping,  S-581 85,  Sweden
Switzerland
      Hopital Cantonal Universitaire de Geneva, Geneva,  CH-1211,  Switzerland
United Kingdom, England
      Derbyshire Royal Infirmary, Derby,  England,  DE1 2QY,  United Kingdom
United Kingdom, Scotland
      Beatson Oncology Centre, Glasgow,  Scotland,  G11 6NT,  United Kingdom

Study chairs or principal investigators

Sergio L. Pecorelli,  Study Chair,  EORTC Gynecological Cancer Cooperative Group   
Gavin C.E. Stuart,  Study Chair

Study ID Numbers:  CDR0000075254; EORTC-55874
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002459
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08