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

Sarcoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002459
• Other study ID #: EORTC-55874
• Secondary ID: EORTC-55874CAN-N
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: September 20, 2012
• Start date: April 1988

Study information

• Verified date: September 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. primary completion date: August 2001
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometrial Cancer
• Sarcoma

Intervention

Radiation:
• radiation therapy

Locations

Country	Name	City	State
Belgium	U.Z. Gasthuisberg	Leuven
Canada	Tom Baker Cancer Center - Calgary	Calgary	Alberta
Canada	CHUS-Hopital Fleurimont	Fleurimont	Quebec
France	Centre Henri Becquerel	Rouen
Italy	Spedali Civili	Brescia
Italy	Istituto Nazionale per lo Studio e la Cura dei Tumori	Milan
Italy	Istituto Scientifico H.S. Raffaele	Milano
Italy	Ospedale San Gerardo	Monza
Italy	Universita di Padova	Padova
Italy	I.R.C.C.S. Policlinico San Matteo	Pavia
Italy	Ospedale di Circolo e Fondazione Macchi	Varese
Italy	Ospedale Civile	Voghera (PV)
Netherlands	Antoni van Leeuwenhoekhuis	Amsterdam
Netherlands	Vrije Universiteit Medisch Centrum	Amsterdam
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	Atrium Medical Centre	Heerlen
Netherlands	Academisch Ziekenhuis Maastricht	Maastricht
Netherlands	University Medical Center Nijmegen	Nijmegen
Netherlands	Rotterdam Cancer Institute	Rotterdam
Netherlands	University Hospital - Rotterdam Dijkzigt	Rotterdam
Netherlands	Academisch Ziekenhuis Utrecht	Utrecht
Poland	Medical University of Gdansk	Gdansk
Spain	Instituto Valenciano De Oncologia	Valencia
Sweden	University Hospital of Linkoping	Linkoping
Sweden	Karolinska Hospital	Stockholm
Switzerland	Hopital Cantonal Universitaire de Geneva	Geneva
United Kingdom	Derbyshire Royal Infirmary	Derby	England
United Kingdom	Beatson Oncology Centre	Glasgow	Scotland

Sponsors (2)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC	Canadian Cancer Trials Group

Countries where clinical trial is conducted

Belgium,  Canada,  France,  Italy,  Netherlands,  Poland,  Spain,  Sweden,  Switzerland,  United Kingdom, 

References & Publications (2)

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.

Reed NS, Mangioni C, Malmström 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 randomise — View Citation