We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Cisplatin Combined With Radiation Therapy and Hyperthermia in Treating Patients With Stage II, Stage III, or Stage IV Cervical Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00008112
Recruitment Status : Unknown
Verified October 2002 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : June 5, 2003
Last Update Posted : August 7, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy use 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. Combining hyperthermia with radiation therapy and chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of cisplatin combined with radiation therapy and hyperthermia in treating patients who have stage II, stage III, or stage IV cervical cancer.

Condition or disease Intervention/treatment Phase
Cervical Cancer Drug: cisplatin Procedure: hyperthermia treatment Radiation: brachytherapy Radiation: radiation therapy Phase 2

Detailed Description:


  • Determine the feasibility of adding cisplatin and locoregional hyperthermia to external beam and intracavity radiotherapy in patients with stage IIB-IVA cervical cancer.
  • Determine the acute toxicity of this regimen in these patients.
  • Determine the complete response rate of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients undergo external beam radiotherapy (EBRT) once daily 5 days a week for 5 weeks. On 1 day of each week, patients also receive cisplatin IV over 3 hours and hyperthermia over 90 minutes beginning 1-6 hours after completion of EBRT. During week 6, patients receive hyperthermia and cisplatin on the day before the 1 day of intracavity radiotherapy. Treatment continues in the absence of unacceptable toxicity.

Patients are followed at 6-8 weeks, every 3 months for 3 years, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 6-34 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Feasibility Study of the Combination of Radiotherapy, Chemotherapy and Hyperthermia for the Treatment of Stage IIB-III-IVA Cervical Cancer
Study Start Date : June 2000

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin
U.S. FDA Resources

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed stage IIB-IVA carcinoma of the cervix

    • Adenocarcinoma
    • Squamous cell carcinoma
    • Mixed cell histology
    • No small cell anaplastic histology
  • No para-aortic lymph node involvement

    • No indication for para-aortic radiotherapy
  • No distant metastases
  • No CNS disease



  • 18 and over

Performance status:

  • WHO 0-2

Life expectancy:

  • More than 3 months


  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 7.0 mmol/L (approximately 11 g/dL)
  • Epoetin alfa and/or transfusion allowed


  • Not specified


  • Glomerular filtration rate at least 60 mL/min


  • No myocardial infarction within the past 6 months
  • No unstable angina
  • No congestive heart failure with expected inability to tolerate fluid load
  • No cerebrovascular accident within the past 6 months


  • No pacemaker and/or metal implants
  • No active uncontrolled infection
  • No compromised immune status
  • No psychosis
  • No other prior malignancy except nonmelanoma skin cancer
  • No mental or other physical inability that would preclude study


Biologic therapy:

  • Not specified


  • No prior chemotherapy

Endocrine therapy:

  • Not specified


  • See Disease Characteristics
  • No prior radiotherapy


  • No prior surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00008112

Academisch Medisch Centrum
Amsterdam, Netherlands, 1105 AZ
University Hospital - Rotterdam Dijkzigt
Rotterdam, Netherlands, 3000 CA
Rotterdam Cancer Institute
Rotterdam, Netherlands, 3075 EA
Academisch Ziekenhuis Utrecht
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Chair: Anneke M. Westermann, MD, PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

ClinicalTrials.gov Identifier: NCT00008112     History of Changes
Other Study ID Numbers: DUT-KWF-CKVO-2000-02
CDR0000068376 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: June 5, 2003    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: October 2002

Keywords provided by National Cancer Institute (NCI):
stage III cervical cancer
stage IIB cervical cancer
stage IVA cervical cancer
cervical squamous cell carcinoma
cervical adenocarcinoma
cervical adenosquamous cell carcinoma

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Body Temperature Changes
Signs and Symptoms
Antineoplastic Agents