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

Last updated: July 10, 2013
Sponsor: Mark Dewhirst
Overall Status: Terminated

Phase

3

Condition

Vaginal Cancer

Cervical Cancer

Fever

Treatment

N/A

Clinical Study ID

NCT00085631
Pro00005267
DUMC-4516
CDR0000370860
  • Ages > 18
  • Female

Study Summary

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: This randomized phase III trial compared the safety and efficacy of cisplatin and radiation therapy, together with hyperthermia therapy versus cisplatin and radiation therapy alone in the treatment of locally advanced cervical cancer.

Eligibility Criteria

Inclusion

Inclusion criteria: Invasive cervical carcinoma (squamous, adeno or adenosquamous histologies, small cellhistology excluded)

  • age >18years

  • International Federation of Gynecology and Obstetrics ((FIGO) stage IB2, IIA-IVA, FIGOstages IA, IB1 with positive pelvic lymph nodes or parametria either on imagingtechniques or pathologically involved at the time of surgery. patients undergoing surgical removal of the cervix and uterus are not eligible, parametriaeither on imaging techniques or pathologically involved at the time • Performance statusEastern Cooperative Oncology Group(ECOG)/World Health Organisation (WHO) 0, 1 or >/=70%respectively White Blood count (WBC) ≥ 3,000, platelets ≥ 100,000, AbsoluteNeutrophil Count (ANC) > 1500

• serum bilirubin ≤ 1.5 times upper limit of normal, transaminase ≤ 3 times upper limit ofnormal calculated creatinine clearance >60milliliters (mls)/liter ( Cockcroft) ORcreatinine </= 2.0mgs% paraaortic adenopathy absent or 1.5 centimeter (cm) in greatestdimension on Computerised Tomography (CT) or Magnetic Resonance Imaging (MRI) scan; No history of myocardial infarction in the last 6 months no symptomatic angina pectorisnegative pregnancy test in patients under 50 Hemoglobin >12.0 Gd/dl or >7.5 mmo;/L withtransfusion if needed written written informed consent

Exclusion

Exclusion criteria: surgical resection of the primary tumor (i.e. Total abdominal hysterectomy (TAH)/ Bilateralsalpingoophorectomy (BSO)

  • patients with pacemakers or implanted defibrillators

  • patients with significant metallic foreign bodies (i.e. hip replacements, bonemetallic rods,orthopedic plates, etc.)

  • prior radiotherapy or chemotherapy

Study Design

Total Participants: 101
Study Start date:
March 01, 2003
Estimated Completion Date:
June 30, 2009

Study Description

OBJECTIVES:

Compare local control, failure-free survival, and overall survival of patients with locally advanced carcinoma of the cervix treated with cisplatin and radiotherapy alone, versus cisplatin and radiotherapy with hyperthermia .

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.

LIMITATIONS:

There are integrity issues with the currently available data, involving international institutions, in that several pieces of information relating to patient accrual and outcomes cannot be verified. Therefore, it would be inappropriate to report outcome measures for this study. Baseline measures of age and gender are reported for the entire study cohort. Participant flow is reported by treatment arm assignment, which was available for a majority of patients in the currently available data. Adverse events are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.

Connect with a study center

  • Charite University Hospital - Campus Virchow Klinikum

    Berlin, D-13353
    Germany

    Site Not Available

  • Strahlenklinik - Universitaetsklinikum Erlangen

    Erlangen, D-91054
    Germany

    Site Not Available

  • Klinikum der Universitaet Muenchen - Grosshadern Campus

    Munich, D-81377
    Germany

    Site Not Available

  • Academisch Medisch Centrum at University of Amsterdam

    Amsterdam, 1105 AZ
    Netherlands

    Site Not Available

  • Haukeland Hospital - University of Bergen

    Bergen, N-5021
    Norway

    Site Not Available

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois 60611-3013
    United States

    Site Not Available

  • Duke Cancer Institute

    Durham, North Carolina 27710
    United States

    Site Not Available

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