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

This study is no longer recruiting patients.

Sponsored by: Academisch Medisch Centrum
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. 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 Treatment or Intervention Phase
cervical squamous cell carcinoma
cervical adenocarcinoma
stage IIB cervical cancer
stage III cervical cancer
cervical adenosquamous cell carcinoma
stage IVA cervical cancer
 Procedure: chemotherapy
 Procedure: hyperthermia
 Procedure: radiation therapy
 Procedure: brachytherapy
 Drug: cisplatin
Phase II

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

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Cisplatin With Radiotherapy and Locoregional Hyperthermia in Patients With Stage IIB-IVA Cervical Cancer

Further Study Details: 

Study start: June 2000

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

PROTOCOL 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.

Eligibility

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

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

No para-aortic lymph node involvement

No distant metastases

No CNS disease

--Prior/Concurrent Therapy--

Biologic therapy: Not specified

Chemotherapy: No prior chemotherapy

Endocrine therapy: Not specified

Radiotherapy:

  • See Disease Characteristics
  • No prior radiotherapy

Surgery: No prior surgery

--Patient Characteristics--

Age: 18 and over

Performance status: WHO 0-2

Life expectancy: More than 3 months

Hematopoietic:

  • WBC at least 3,000/mm3
  • Absolute neutrophil count at least 1,500/mm3
  • Platelet count at least 100,000/mm3
  • Hemoglobin at least 7.0 mmol/L (approximately 11 g/dL)
  • Epoetin alfa and/or transfusion allowed

Hepatic: Not specified

Renal: Glomerular filtration rate at least 60 mL/min

Cardiovascular:

  • 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

Other:

  • 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

Location Information


Netherlands
      Academisch Medisch Centrum, Amsterdam,  1105 AZ,  Netherlands

      Academisch Ziekenhuis Utrecht, Utrecht,  3584 CX,  Netherlands

      Rotterdam Cancer Institute, Rotterdam,  3075 EA,  Netherlands

      University Hospital - Rotterdam Dijkzigt, Rotterdam,  3000 CA,  Netherlands

Study chairs or principal investigators

Anneke Westermann,  Study Chair,  Academisch Medisch Centrum   

More Information

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

Study ID Numbers:  CDR0000068376; DUT-KWF-CKVO-2000-02; EU-20036
Record last reviewed:  June 2003
Last Updated:  October 13, 2004
Record first received:  January 6, 2001
ClinicalTrials.gov Identifier:  NCT00008112
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


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

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