Clinical trial NCT00002459: Radiation Therapy or No Further Treatment Following Surgery in Treating Patients With Cancer of the Uterus
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Endometrial Cancer
Sarcoma
Keywords: stage I uterine sarcoma
stage II uterine sarcoma
uterine carcinosarcoma
uterine leiomyosarcoma
endometrial stromal sarcoma
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
Collaborators: name: NCIC Clinical Trials Group
First posted: 2004-03-11
Enrollment: 224
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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.

Eligibility 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

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: U.Z. Gasthuisberg
city: Calgary
country: Canada
facility: Tom Baker Cancer Center - Calgary
state: Alberta
city: Fleurimont
country: Canada
facility: CHUS-Hopital Fleurimont
state: Quebec
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Brescia
country: Italy
facility: Spedali Civili
city: Milano
country: Italy
facility: Istituto Scientifico H.S. Raffaele
city: Milan
country: Italy
facility: Istituto Nazionale per lo Studio e la Cura dei Tumori
city: Monza
country: Italy
facility: Ospedale San Gerardo
city: Padova
country: Italy
facility: Universita di Padova
city: Pavia
country: Italy
facility: I.R.C.C.S. Policlinico San Matteo
city: Varese
country: Italy
facility: Ospedale di Circolo e Fondazione Macchi
city: Voghera (PV)
country: Italy
facility: Ospedale Civile
city: Amsterdam
country: Netherlands
facility: Vrije Universiteit Medisch Centrum
city: Amsterdam
country: Netherlands
facility: Antoni van Leeuwenhoekhuis
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Heerlen
country: Netherlands
facility: Atrium Medical Centre
city: Maastricht
country: Netherlands
facility: Academisch Ziekenhuis Maastricht
city: Nijmegen
country: Netherlands
facility: University Medical Center Nijmegen
city: Rotterdam
country: Netherlands
facility: University Hospital - Rotterdam Dijkzigt
city: Rotterdam
country: Netherlands
facility: Rotterdam Cancer Institute
city: Utrecht
country: Netherlands
facility: Academisch Ziekenhuis Utrecht
city: Gdansk
country: Poland
facility: Medical University of Gdansk
city: Valencia
country: Spain
facility: Instituto Valenciano De Oncologia
city: Linkoping
country: Sweden
facility: University Hospital of Linkoping
city: Stockholm
country: Sweden
facility: Karolinska Hospital
city: Geneva
country: Switzerland
facility: Hopital Cantonal Universitaire de Geneva
city: Derby
country: United Kingdom
facility: Derbyshire Royal Infirmary
state: England
city: Glasgow
country: United Kingdom
facility: Beatson Oncology Centre
state: Scotland
Study officials:
affiliation: Spedali Civili di Brescia
name: Sergio L. Pecorelli, MD
role: STUDY_CHAIR
affiliation: Tom Baker Cancer Centre - Calgary
name: Gavin C.E. Stuart, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.