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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002459
Recruitment Status : Completed
First Posted : March 11, 2004
Last Update Posted : September 24, 2012
NCIC Clinical Trials Group
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary:

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 or disease Intervention/treatment Phase
Endometrial Cancer Sarcoma Radiation: radiation therapy Phase 3

Detailed Description:

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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Primary Purpose: Treatment
Official Title: Phase III Randomized Study of Adjuvant Pelvic Radiotherapy Versus Observation Alone in Patients With Completely Resected, Stage I or II, High-Grade Uterine Sarcoma
Study Start Date : April 1988
Actual Primary Completion Date : August 2001

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002459

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

Publications of Results:
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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00002459     History of Changes
Other Study ID Numbers: EORTC-55874
First Posted: March 11, 2004    Key Record Dates
Last Update Posted: September 24, 2012
Last Verified: September 2012

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
stage I uterine sarcoma
stage II uterine sarcoma
uterine carcinosarcoma
uterine leiomyosarcoma
endometrial stromal sarcoma

Additional relevant MeSH terms:
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Endometrial Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female