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

This study is currently recruiting patients.

Sponsored by: European Organization for Research and Treatment of Cancer
Information provided by: National Cancer Institute (NCI)

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.

Condition Treatment or Intervention Phase
stage IB cervical cancer
stage IIB cervical cancer
stage IIA cervical cancer
cervical squamous cell carcinoma
cervical adenocarcinoma
cervical adenosquamous cell carcinoma
 Drug: cisplatin
 Procedure: brachytherapy
 Procedure: chemotherapy
 Procedure: conventional surgery
 Procedure: neoadjuvant therapy
 Procedure: radiation therapy
 Procedure: surgery
Phase III

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Cervical Cancer;   Soft Tissue Sarcoma

Study Type: Interventional
Study Design: Treatment

Official Title: 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

Further Study Details: 

OBJECTIVES:

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.

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

Eligibility

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

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

Location and Contact Information


Argentina
      Hospital de Clinicas "Jose De San Martin", Buenos Aires,  1120,  Argentina; Recruiting
Contact Person  54-1-5950-8000 

Austria
      Kaiser Franz Josef Hospital, Vienna,  A-1100,  Austria; Recruiting
Contact Person  43-1-601-9152 

      Karl-Franzens-University Graz, Graz,  A-8010,  Austria; Recruiting
Contact Person  43-316-380-4100 

Belgium
      U.Z. Gasthuisberg, Leuven,  B-3000,  Belgium; Recruiting
Contact Person  32-16-332-211 

Italy
      Clinica Universita, Turin,  10126,  Italy; Recruiting
Contact Person  39-11-434-5345 

      European Institute of Oncology, Milano,  20141,  Italy; Recruiting
Contact Person  39-2-574-891 

      Istituto Nazionale per lo Studio e la Cura dei Tumori, Naples,  80131,  Italy; Recruiting
Contact Person  39-81-590-3269 

      Ospedale di Circolo e Fondazione Macchi, Varese,  21100,  Italy; Recruiting
Contact Person  39-0332-278-376 

      Ospedale San Gerardo, Monza,  20052,  Italy; Recruiting
Contact Person  39-039-2331 

Netherlands
      Academisch Medisch Centrum, Amsterdam,  1105 AZ,  Netherlands; Recruiting
Contact Person  31-20-566-9111 

      Daniel Den Hoed Cancer Center at Erasmus Medical Center, Rotterdam,  3008 AE,  Netherlands; Recruiting
Contact Person  31-10-439-1911 

      Leiden University Medical Center, Leiden,  2300 RC,  Netherlands; Recruiting
Contact Person  31-71-526-911 

      Medisch Spectrum Twente, ENSCHEDE,  7500 KA,  Netherlands; Recruiting
Contact Person  31-53-487-2000 

      University Medical Center Nijmegen, Nijmegen,  NL-6500 HB,  Netherlands; Recruiting
Contact Person  31-80-361-1111 

      University Medical Center Utrecht, Utrecht,  3584 CX,  Netherlands; Recruiting
Contact Person  31-30-250-6266 

      Vrije Universiteit Medisch Centrum, Amsterdam,  1007 MB,  Netherlands; Recruiting
Contact Person  31-20-444-4300 

Poland
      Medical University of Gdansk, Gdansk,  80-211,  Poland; Recruiting
Contact Person  48-58-349-2222 

Portugal
      Hospitais da Universidade de Coimbra (HUC), Coimbra,  3001-301,  Portugal; Recruiting
Contact Person  351-39-403-939 

Spain
      Hospital Universitario San Carlos, Madrid,  28040,  Spain; Recruiting
Contact Person  34-330-3000 

United Kingdom, England
      Queen Elizabeth The Queen Mother Hospital, Margate,  England,  CT9 4AN,  United Kingdom; Recruiting
Contact Person  44-1843-225-544 

United Kingdom, Scotland
      Western Infirmary, Glasgow,  Scotland,  G11 6NT,  United Kingdom; Recruiting
Contact Person  44-141-330-4006 

Study chairs or principal investigators

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

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000069375; EORTC-55994; NCT00039338
Record last reviewed:  January 2005
Last Updated:  April 4, 2005
Record first received:  June 6, 2002
ClinicalTrials.gov Identifier:  NCT00039338
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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