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

NCT00002459 | Completed Phase 3

• 2 other identifiers: EORTC-55874CAN-NCIC-EN4
• Study Type: interventional
• Target: 224
• Locations: 10 countries
• Sites: 28

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.

Conditions

Endometrial Cancer; Sarcoma

Keywords

stage I uterine sarcoma; stage II uterine sarcoma; uterine carcinosarcoma; uterine leiomyosarcoma; endometrial stromal sarcoma

Interventions

radiation therapy RADIATION

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead
• NCIC Clinical Trials Group: collaborator

Study Sites (28)

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Tom Baker Cancer Center - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

CHUS-Hopital Fleurimont

Fleurimont, Quebec, J1H 5N4, Canada

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Spedali Civili

Brescia, 25124, Italy

Location

Istituto Nazionale per lo Studio e la Cura dei Tumori

Milan, 20133, Italy

Location

Istituto Scientifico H.S. Raffaele

Milan, 20132, Italy

Location

Ospedale San Gerardo

Monza, 20052, Italy

Location

Universita di Padova

Padua, 35128, Italy

Location

I.R.C.C.S. Policlinico San Matteo

Pavia, 27100, Italy

Location

Ospedale di Circolo e Fondazione Macchi

Varese, 21100, Italy

Location

Ospedale Civile

Voghera (PV), 27058, Italy

Location

Vrije Universiteit Medisch Centrum

Amsterdam, 1001HV, Netherlands

Location

Antoni van Leeuwenhoekhuis

Amsterdam, 1066 CX, Netherlands

Location

Medisch Spectrum Twente

Enschede, 7500 KA, Netherlands

Location

Atrium Medical Centre

Heerlen, 6419 PC, Netherlands

Location

Academisch Ziekenhuis Maastricht

Maastricht, 6202 AZ, Netherlands

Location

University Medical Center Nijmegen

Nijmegen, NL-6252 HB, Netherlands

Location

University Hospital - Rotterdam Dijkzigt

Rotterdam, 3000 CA, Netherlands

Location

Rotterdam Cancer Institute

Rotterdam, 3075 EA, Netherlands

Location

Academisch Ziekenhuis Utrecht

Utrecht, 3508 GA, Netherlands

Location

Medical University of Gdansk

Gdansk, 80-211, Poland

Location

Instituto Valenciano De Oncologia

Valencia, 46009, Spain

Location

University Hospital of Linkoping

Linköping, S-581 85, Sweden

Location

Karolinska Hospital

Stockholm, S-171 76, Sweden

Location

Hopital Cantonal Universitaire de Geneva

Geneva, CH-1211, Switzerland

Location

Derbyshire Royal Infirmary

Derby, England, DE1 2QY, United Kingdom

Location

Beatson Oncology Centre

Glasgow, Scotland, G11 6NT, United Kingdom

Location

Related Publications (2)

• Reed NS, Mangioni C, Malmstrom H, Scarfone G, Poveda A, Pecorelli S, Tateo S, Franchi M, Jobsen JJ, Coens C, Teodorovic I, Vergote I, Vermorken JB; European Organisation for Research and Treatment of Cancer Gynaecological Cancer Group. Phase III randomised study to evaluate the role of adjuvant pelvic radiotherapy in the treatment of uterine sarcomas stages I and II: an European Organisation for Research and Treatment of Cancer Gynaecological Cancer Group Study (protocol 55874). Eur J Cancer. 2008 Apr;44(6):808-18. doi: 10.1016/j.ejca.2008.01.019. Epub 2008 Apr 2.

  PMID: 18378136 RESULT

• Reed NS, Mangioni C, Malmstrom H, et al.: First results of a randomised trial comparing radiotherapy versus observation post operatively in patients with uterine sarcomas. An EORTC-GCG study. [Abstract] Int J Gynecol Cancer 13 (Suppl 1): A-PL12, 4, 2003.

  RESULT

MeSH Terms

Conditions

Endometrial Neoplasms; Sarcoma; Sarcoma, Endometrial Stromal

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms, Complex and Mixed; Endometrial Stromal Tumors

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Sergio L. Pecorelli, MD

  Spedali Civili di Brescia

  STUDY CHAIR

• Gavin C.E. Stuart, MD

  Tom Baker Cancer Centre - Calgary

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: March 11, 2004
• Study Start: April 1, 1988
• Primary Completion: August 1, 2001
• Last Updated: September 24, 2012

Record last verified: 2012-09

Locations

NL (9); SE (2); BE (1); GB (2); CA (2); FR (1); IT (8); ES (1); PL (1); CH (1)