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Radiation Therapy or No Further Treatment Following Surgery in Treating Patients With Cancer of the Uterus Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Radiation Therapy or No Further Treatment Following Surgery in Treating Patients With Cancer of the Uterus conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Radiation Therapy or No Further Treatment Following Surgery in Treating Patients With Cancer of the Uterus Clinical research trials and Radiation Therapy or No Further Treatment Following Surgery in Treating Patients With Cancer of the Uterus medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Radiation Therapy or No Further Treatment Following Surgery in Treating Patients With Cancer of the Uterus. Radiation Therapy or No Further Treatment Following Surgery in Treating Patients With Cancer of the Uterus Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Radiation Therapy or No Further Treatment Following Surgery in Treating Patients With Cancer of the Uterus clinical trial. Subjects often receive the most expert healthcare possible for their Radiation Therapy or No Further Treatment Following Surgery in Treating Patients With Cancer of the Uterus condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.

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



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

For Condition: uterine leiomyosarcoma,uterine carcinosarcoma,stage 2 uterine sarcoma,Endometrial Stromal Sarcoma,stage 1 uterine sarcoma
Status: No longer recruiting
Sponsor(s): EORTC Gynecological Cancer Cooperative Group , National Cancer Institute of Canada
Synopsis: 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.
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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: 
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
SergioPecorelli,  Study Chair,  EORTC Gynecological Cancer Cooperative Group

Vrije Universiteit Medisch Centrum
Amsterdam,  ,  1001HV
Netherlands
 

Antoni van Leeuwenhoekhuis
Amsterdam,  ,  1066 CX
Netherlands
 

University Hospital - Rotterdam Dijkzigt
Rotterdam,  ,  3000 CA
Netherlands
 

Ospedale San Gerardo
Monza,  ,  20052
Italy
 

Rotterdam Cancer Institute
Rotterdam,  ,  3075 EA
Netherlands
 

U.Z. Gasthuisberg
Leuven,  ,  B-3000
Belgium
 

Istituto Nazionale per lo Studio e la Cura dei Tumori
Milan,  ,  20133
Italy
 

Medical University of Gdansk
Gdansk,  ,  80-211
Poland
 

Derbyshire Royal Infirmary
Derby,  England,  DE1 2QY
United Kingdom
 

Academisch Ziekenhuis Maastricht
Maastricht,  ,  6202 AZ
Netherlands
 

CHUS-Hopital Fleurimont
Fleurimont,  Quebec,  J1H 5N4
Canada
 

University Medical Center Nijmegen
Nijmegen,  ,  NL-6252 HB
Netherlands
 

University Hospital of Linkoping
Linkoping,  ,  S-581 85
Sweden
 

Istituto Scientifico H.S. Raffaele
Milano,  ,  20132
Italy
 

Karolinska Hospital
Stockholm,  ,  S-171 76
Sweden
 

Ospedale Civile
Voghera (PV),  ,  27058
Italy
 

Beatson Oncology Centre
Glasgow,  Scotland,  G11 6NT
United Kingdom
 

Hopital Cantonal Universitaire de Geneva
Geneva,  ,  CH-1211
Switzerland
 

Tom Baker Cancer Center - Calgary
Calgary,  Alberta,  T2N 4N2
Canada
 

Universita di Padova
Padova,  ,  35128
Italy
 

Medisch Spectrum Twente
ENSCHEDE,  ,  7500 KA
Netherlands
 

Spedali Civili
Brescia,  ,  25124
Italy
 

Instituto Valenciano De Oncologia
Valencia,  ,  46009
Spain
 

I.R.C.C.S. Policlinico San Matteo
Pavia,  ,  27100
Italy
 

Atrium Medical Centre
HEERLEN,  ,  6419 PC
Netherlands
 

Ospedale di Circolo e Fondazione Macchi
Varese,  ,  21100
Italy
 

Centre Henri Becquerel
Rouen,  ,  76038
France
 

Academisch Ziekenhuis Utrecht
Utrecht,  ,  3508 GA
Netherlands
 


Additional Information:
Study ID Numbers:
  CDR0000075254;  EORTC-55874
Study Start Date: April 1988
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002459

Other Uterine Leiomyosarcoma Studies:
1. Gemcitabine in Treating Patients With Recurrent or Refractory Cancer of the Uterus

2. Temozolomide and Thalidomide in Treating Patients With Metastatic, Locally Advanced, or Unresectable Leiomyosarcoma

3. Paclitaxel in Treating Patients With Recurrent or Persistent Cancer of the Uterus

4. Combination Chemotherapy and Filgrastim in Treating Patients With Recurrent or Persistent Cancer of the Uterus

5. Thalidomide in Treating Patients With Recurrent or Persistent Cancer of the Uterus

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