Clinical Trial: Cisplatin and Radiation Therapy With or Without Hyperthermia Therapy in Treating Patients With Cervical Cancer

This study is currently recruiting patients.

Sponsors and Collaborators: Duke Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature. It is not yet known whether chemotherapy and radiation therapy are more effective with or without hyperthermia therapy in treating cervical cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of combining cisplatin and radiation therapy with or without hyperthermia therapy in treating patients who have locally advanced cervical cancer.

Condition Treatment or Intervention Phase
Cervical Cancer
 Drug: cisplatin
 Procedure: brachytherapy
 Procedure: chemotherapy
 Procedure: hyperthermia
 Procedure: radiation therapy
Phase III

MedlinePlus related topics:  Cervical Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III Randomized Study of Cisplatin and Radiotherapy With or Without Hyperthermia in Patients With Locally Advanced Carcinoma of the Cervix

Further Study Details: 

OBJECTIVES:

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, disease stage (IIB or IIIA vs IIIB or IVA) and age (< 60 years vs ≥ 60 years). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive cisplatin IV and concurrently undergo hyperthermia over 60-90 minutes on day 1. Patients also undergo external beam radiotherapy once daily on days 1-5. Treatment repeats weekly for 5-6 weeks in the absence of disease progression or unacceptable toxicity. After completion of chemoradiotherapy and hyperthermia, patients undergo brachytherapy to the cervix for 2-3 days.
  • Arm II: Patients receive cisplatin and undergo radiotherapy (including brachytherapy) as in arm I. Patients are followed at 4-6 weeks, every 3 months for 2 years, every 6 months for 5 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 400 patients (200 per treatment arm) will be accrued for this study within 5 years.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

PATIENT CHARACTERISTICS: Age

  • 18 and over

Performance status

  • ECOG 0-2 OR
  • WHO 70-100%

Life expectancy

  • Not specified

Hematopoietic

  • WBC ≥ 3,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Absolute neutrophil count > 1,500/mm^3
  • Hemoglobin > 12.0 g/dL (transfusion allowed)

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • Transaminase ≤ 3 times ULN

Renal

  • Creatinine clearance > 60 mL/min

Cardiovascular

  • No myocardial infarction within the past 6 months
  • No symptomatic angina pectoris

Other

  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy

Surgery

  • See Disease Characteristics

Other

  • No pacemakers or implanted defibrillators
  • No significant metallic foreign bodies (e.g., hip replacements, bone metallic rods, or orthopedic plates)

Location and Contact Information


North Carolina
      Duke Comprehensive Cancer Center, North Carolina,  27710,  United States; Recruiting
Ellen L. Jones, MD, PhD  919-668-5221 

Germany
      Klinikum Grosshadern der Ludwig-Maximilians Universitaet Muenchen, Munich,  D-81377,  Germany; Recruiting
Lars H. Linder, MD  49-89-7095-0    lars.linder@med.uni-muenchen.de 

Netherlands
      Academisch Medisch Centrum, Amsterdam,  1105 AZ,  Netherlands; Recruiting
Anneke Westermann, MD  31-20-566-5955 ext. 58919    a.m.westermann@amc.uva.nl 

Norway
      Haukeland Hospital - University of Bergen, BERGEN,  N-5021,  Norway; Recruiting
Baard-Christian Schem, MD  47-5597-4019 

Study chairs or principal investigators

Ellen L. Jones, MD, PhD,  Principal Investigator,  Duke Comprehensive Cancer Center   
Leonard R. Prosnitz, MD,  Principal Investigator,  Duke Comprehensive Cancer Center   

More Information

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

Study ID Numbers:  CDR0000370860; DUMC-4516-04-2R1ER; DUMC-G030263; DUMC-4516031R0; NCT00085631
Record last reviewed:  February 2005
Last Updated:  April 4, 2005
Record first received:  June 10, 2004
ClinicalTrials.gov Identifier:  NCT00085631
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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