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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

This study is currently Recruiting

July 2009 By National Cancer Institute (NCI)

First Recieved on June 6, 2002

Last Updated on July 22, 2009

Sponsor: European Organization for Research and Treatment of Cancer - EORTC
Collaborators:
Information provided by: National Cancer Institute (NCI)
Identifier: NCT00039338

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor so that it can be removed during surgery. Radiation therapy uses high-energy x-rays to kill tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. It is not yet known whether chemotherapy is more effective followed by surgery or combined with radiation therapy in treating cervical cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy followed by radical hysterectomy with that of chemotherapy plus radiation therapy in treating patients who have stage IB or stage II cervical cancer.

Study Type: Interventional
Study Design: Allocation: Randomized, Primary Purpose: Treatment

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Female
Accepts Healthy Volunteers:No
Criteria

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

Investigators

  • Investigator: Fabio Landoni, MD - - European Institute of Oncology
  • Investigator: Nicoletta Colombo, MD - - European Institute of Oncology
  • Investigator: Stefano Greggi, MD, PhD - - Istituto Nazionale per lo Studio e la Cura dei Tumori
  • Investigator: Gemma G. Kenter, MD - - Leiden University Medical Center

Locations

  • Hospital de Clinicas "Jose De San Martin"

    Buenos Aires, 1120 Argentina

  • Karl-Franzens-University Graz

    Graz, A-8010 Austria

  • Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital

    Vienna, A-1100 Austria

  • Universitair Ziekenhuis Antwerpen

    Edegem, B-2650 Belgium

  • U.Z. Gasthuisberg

    Leuven, B-3000 Belgium

  • Centre Hospitalier Regional de la Citadelle

    Liege, 4000 Belgium

  • European Institute of Oncology

    Milano, 20141 Italy

  • Ospedale San Gerardo

    Monza, 20052 Italy

  • Istituto Nazionale per lo Studio e la Cura dei Tumori

    Naples, 80131 Italy

  • Azienda Sanitaria Ospedaliera Ordine Mauriziano

    Torino, 10128 Italy

  • Clinica Universitaria

    Turin, 10126 Italy

  • Ospedale di Circolo e Fondazione Macchi

    Varese, 21100 Italy

  • Academisch Medisch Centrum at University of Amsterdam

    Amsterdam, 1105 AZ Netherlands

  • Vrije Universiteit Medisch Centrum

    Amsterdam, 1007 MB Netherlands

  • Medisch Spectrum Twente

    Enschede, 7500 KA Netherlands

  • Leiden University Medical Center

    Leiden, 2300 RC Netherlands

  • Universitair Medisch Centrum St. Radboud - Nijmegen

    Nijmegen, NL-6500 HB Netherlands

  • Daniel Den Hoed Cancer Center at Erasmus Medical Center

    Rotterdam, 3008 AE Netherlands

  • University Medical Center Utrecht

    Utrecht, 3584 CX Netherlands

  • Medical University of Gdansk

    Gdansk, 80-211 Poland

  • Hospitais da Universidade de Coimbra (HUC)

    Coimbra, 3001-301 Portugal

  • Hospital Universitario San Carlos

    Madrid, 28040 Spain

  • Queen Elizabeth The Queen Mother Hospital

    Margate, England CT9 4AN United Kingdom

  • Gartnavel General Hospital

    Glasgow, Scotland G12 0YN United Kingdom

  • Western Infirmary

    Glasgow, Scotland G11 6NT United Kingdom

Conditions related to this trial:

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