Chemotherapy Followed By Surgery Vs Radiotherapy Plus Chemotherapy in Patients With Stage IB or II Cervical Cancer

NCT00039338UNKNOWNPHASE3INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Enrollment

686

Start Date

2002-03-01

Completion Date

2019-07-01

Study Type

INTERVENTIONAL

Official Title

Randomized Phase III Study Of Neoadjuvant Chemotherapy Followed By Surgery Vs. Concomitant Radiotherapy And Chemotherapy In FIGO Ib2, IIa>4 cm or IIb Cervical Cancer

Interventions

conventional surgeryneoadjuvant chemotherapybrachytherapyradiation therapycisplatin

Conditions

Cervical Cancer

Eligibility

Age Range

18 Years – 75 Years

Sex

FEMALE

DISEASE CHARACTERISTICS:

* Histologically confirmed cervical cancer, including the following subtypes:

  * Squamous cell carcinoma
  * Adenosquamous cell carcinoma
  * Adenocarcinoma (excluding small cell, clear cell, and other rare variants of the classical adenocarcinoma)
* FIGO stage IB2, IIA (greater than 4 cm), or IIB

PATIENT CHARACTERISTICS:

Age:

* 18 to 75

Performance status:

* WHO 0-2

Life expectancy:

* Not specified

Hematopoietic:

* Absolute neutrophil count greater than 1,500/mm\^3
* Platelet count greater than 100,000/mm\^3

Hepatic:

* Bilirubin less than 1.46 mg/dL

Renal:

* Creatinine clearance greater than 60 mL/min

Other:

* No other prior or concurrent malignancy except adequately treated basal cell skin cancer
* No psychological, familial, sociological, or geographical condition that would preclude study
* Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* No prior radiotherapy

Surgery:

* Not specified

Other:

* No other concurrent anticancer agent

Outcome Measures

Primary Outcomes

Overall survival at 5 years

Time frame: 5 years

Locations

Karl-Franzens-University Graz, Graz, Austria

Kaiser Franz Josef Hospital, Vienna, Austria

Universitair Ziekenhuis Antwerpen, Edegem, Belgium

U.Z. Gasthuisberg, Leuven, Belgium

Centre Hospitalier Regional de la Citadelle, Liège, Belgium

Centre Regional Francois Baclesse, Caen, France

Istituto Europeo Di Oncologia, Milan, Italy

Ospedale San Gerardo, Monza, Italy

Istituto Nazionale Per Lo Studio E La Cura Dei Tumori, Naples, Italy

Ospedale Mauriziano Umberto I, Torino, Italy

Clinica Universitaria, Turin, Italy

Ospedale di Circolo e Fondazione Macchi, Varese, Italy

Academisch Medisch Centrum at University of Amsterdam, Amsterdam, Netherlands

Vrije Universiteit Medisch Centrum, Amsterdam, Netherlands

Medisch Spectrum Twente, Enschede, Netherlands

Leiden University Medical Center, Leiden, Netherlands

Universitair Medisch Centrum St. Radboud - Nijmegen, Nijmegen, Netherlands

Erasmus MC - Daniel den Hoed Cancer Center, Rotterdam, Netherlands

Universitair Medisch Centrum - Academisch Ziekenhuis, Utrecht, Netherlands

Hospitais da Universidade de Coimbra (HUC), Coimbra, Portugal

Hospital Universitario San Carlos, Madrid, Spain

Queen Elizabeth The Queen Mother Hospital, Margate, United Kingdom

NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom

Mid Kent Oncology Centre, Maidstone, Kent, United Kingdom

Chemotherapy Followed By Surgery Vs Radiotherapy Plus Chemotherapy in Patients With Stage IB or II Cervical Cancer