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Last Modified: 10/23/2007     First Published: 6/1/2002  
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Phase III Randomized Study of Neoadjuvant Cisplatin-Based Chemotherapy Followed By Radical Hysterectomy Versus Standard Therapy With Concurrent Radiotherapy and Cisplatin-Based Chemotherapy in Patients With Stage IB2, IIA, or IIB Cervical Cancer

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Chemotherapy Followed By Surgery Compared With Radiation Therapy Plus Chemotherapy in Treating Patients With Stage IB or Stage II Cervical Cancer

Basic Trial Information

Phase
 Type
 Status
 Age
 Sponsor
 Protocol IDs

Phase III
Treatment
Active
18 to 75
Other
EORTC-55994
NCT00039338

Objectives

  1. Compare the overall and progression-free survival of patients with stage IB2, IIA, or IIB cervical cancer treated with neoadjuvant cisplatin-based chemotherapy followed by radical hysterectomy vs standard therapy comprising concurrent radiotherapy and cisplatin-based chemotherapy.
  2. Compare the toxicity of these regimens in these patients.
  3. Compare the quality of life of patients treated with these regimens.

Entry 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


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

Patient Characteristics:

Age:

  • 18 to 75

Performance status:

  • WHO 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count greater than 1,500/mm3
  • Platelet count greater than 100,000/mm3

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

Expected Enrollment

686

A total of 686 patients (343 per treatment arm) will be accrued for this study within 3.8 years.

Outcomes

Primary Outcome(s)

Overall survival as measured by Kaplan Meier after each course, every 3 months for 1 year, every 6 months for 4 years, and then annually

Secondary Outcome(s)

Progression-free survival as measured by Kaplan Meier and RECIST after each course, every 3 months for 1 year, every 6 months for 4 years, and then annually
Toxicity as measured by NCIC Common Toxicity Criteria v2.0 after each course
Health-related quality of life as measured by Quality of Life Questionnaire-C30 before randomization, after completion of study treatment, every 3 months for 1 year, and then every 6 months for 4 years

Outline

This is a randomized, multicenter study. Patients are stratified according to participating center, FIGO stage, age (18 to 50 vs 51 to 75), and histological subtype (adenomatous vs non-adenomatous component). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive neoadjuvant cisplatin-based chemotherapy on day 1. Treatment repeats every 21 days. Within 6 weeks after the last chemotherapy course, patients undergo a type III-V Piver-Rutledge radical hysterectomy. Patients with positive lymph nodes or tumor invasion into the parametria or less than 5 mm from the resection borders after surgery receive standard adjuvant external beam radiotherapy once daily, 5 days a week, for 5-5.6 weeks (25-28 treatment days) followed by external boost radiotherapy or brachytherapy for 1 or 2 days.


  • Arm II: Patients receive standard therapy comprising radiotherapy as in arm I concurrently with cisplatin-based chemotherapy once weekly for 6 weeks. Adjuvant hysterectomy is allowed, but not recommended, in case of histologically proven residual tumor.


Treatment in both arms continues in the absence of disease progression or unacceptable toxicity. For patients in both arms, cisplatin may be combined with other chemotherapeutics as long as the minimum platinum dose is given.

Quality of life is assessed at baseline, after completion of the last chemotherapy course (arm I) or 4-8 weeks after completion of chemoradiotherapy (arm II), every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter.

Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Fabio Landoni, MD, Study coordinator
Ph: 39-02-5748-954-243
Nicoletta Colombo, MD, Study coordinator
Ph: 39-02-5748-9543
Email: nicoletta.colombo@ieo.it
Stefano Greggi, MD, PhD, Study coordinator
Ph: 39-081-590-3320-390
Email: s.greggi@tin.it
Gemma Kenter, MD, Study coordinator
Ph: 31-71-526-9111
Email: g.g.kenter@lumc.nl

Trial Sites

Argentina
  Buenos Aires
 Hospital de Clinicas "Jose De San Martin"
 Contact Person
Ph: 54-1-5950-8000
Austria
  Graz
 Karl-Franzens-University Graz
 Contact Person
Ph: 43-316-380-4100
  Vienna
 Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital
 Contact Person
Ph: 43-1-601-9152
Belgium
  Leuven
 U.Z. Gasthuisberg
 Contact Person
Ph: 32-16-332-211
  Liege
 Centre Hospitalier Regional de la Citadelle
 Contact Person
Ph: 32-4-225-6111
Italy
  Milano
 European Institute of Oncology
 Contact Person
Ph: 39-2-574-891
  Monza
 Ospedale San Gerardo
 Contact Person
Ph: 39-039-2331
  Naples
 Istituto Nazionale per lo Studio e la Cura dei Tumori
 Contact Person
Ph: 39-81-590-3269
  Torino
 Azienda Sanitaria Ospedaliera Ordine Mauriziano
 Contact Person
Ph: 39-11-508-1111
  Turin
 Clinica Universitaria
 Contact Person
Ph: 39-11-434-5345
  Varese
 Ospedale di Circolo e Fondazione Macchi
 Contact Person
Ph: 39-0332-278-376
Netherlands
  Amsterdam
 Academisch Medisch Centrum at University of Amsterdam
 Contact Person
Ph: 31-20-566-9111
 Vrije Universiteit Medisch Centrum
 Contact Person
Ph: 31-20-444-4300
  Enschede
 Medisch Spectrum Twente
 Contact Person
Ph: 31-53-487-2000
  Leiden
 Leiden University Medical Center
 Contact Person
Ph: 31-71-526-911
  Nijmegen
 Universitair Medisch Centrum St. Radboud - Nijmegen
 Contact Person
Ph: 31-80-361-1111
  Rotterdam
 Daniel Den Hoed Cancer Center at Erasmus Medical Center
 Contact Person
Ph: 31-10-439-1911
  Utrecht
 University Medical Center Utrecht
 Contact Person
Ph: 31-30-250-6266
Poland
  Gdansk
 Medical University of Gdansk
 Contact Person
Ph: 48-58-349-2222
Portugal
  Coimbra
 Hospitais da Universidade de Coimbra (HUC)
 Contact Person
Ph: 351-39-403-939
Spain
  Madrid
 Hospital Universitario San Carlos
 Contact Person
Ph: 34-330-3000
United Kingdom
England
  Margate
 Queen Elizabeth The Queen Mother Hospital
 Contact Person
Ph: 44-1843-225-544
Scotland
  Glasgow
 Gartnavel General Hospital
 Contact Person
Ph: 44-141-211-3242
 Western Infirmary
 Contact Person
Ph: 44-141-330-4006

Registry Information
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
Trial Start Date 2002-03-19
Registered in ClinicalTrials.gov NCT00039338
Date Submitted to PDQ 2002-04-15
Information Last Verified 2008-04-13

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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