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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2002 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00008112
First received: January 6, 2001
Last updated: August 6, 2013
Last verified: October 2002
  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 Intervention Phase
Cervical Cancer
Drug: cisplatin
Procedure: hyperthermia treatment
Radiation: brachytherapy
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 2000
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • WHO 0-2

Life expectancy:

  • More than 3 months

Hematopoietic:

  • 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

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

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00008112

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00008112     History of Changes
Other Study ID Numbers: DUT-KWF-CKVO-2000-02, CDR0000068376, EU-20036
Study First Received: January 6, 2001
Last Updated: August 6, 2013
Health Authority: United States: Federal Government

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
Fever
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Body Temperature Changes
Signs and Symptoms
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 19, 2014