Radiation Therapy or No Further Treatment Following Surgery in Treating Patients With Cancer of the Uterus
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Endometrial Cancer Sarcoma |
Radiation: radiation therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | 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 |
| Enrollment: | 224 |
| Study Start Date: | April 1988 |
| Primary Completion Date: | August 2001 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Genders 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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00002459
| Belgium | |
| 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 | |
| France | |
| Centre Henri Becquerel | |
| Rouen, France, 76038 | |
| Italy | |
| 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 | |
| Netherlands | |
| 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 | |
| Poland | |
| Medical University of Gdansk | |
| Gdansk, Poland, 80-211 | |
| Spain | |
| Instituto Valenciano De Oncologia | |
| Valencia, Spain, 46009 | |
| Sweden | |
| University Hospital of Linkoping | |
| Linkoping, Sweden, S-581 85 | |
| Karolinska Hospital | |
| Stockholm, Sweden, S-171 76 | |
| Switzerland | |
| 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 | |
| Study Chair: | Sergio L. Pecorelli, MD | Spedali Civili di Brescia |
| Study Chair: | Gavin C.E. Stuart, MD | Tom Baker Cancer Centre - Calgary |
More Information
Publications:
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00002459 History of Changes |
| Other Study ID Numbers: | EORTC-55874 CAN-NCIC-EN4 |
| Study First Received: | November 1, 1999 |
| Last Updated: | September 20, 2012 |
| Health Authority: | United States: Federal Government |
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:
|
Sarcoma Endometrial Neoplasms Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Uterine Neoplasms |
Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Uterine Diseases Genital Diseases, Female |
ClinicalTrials.gov processed this record on September 27, 2016