- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00008112
Cisplatin Combined With Radiation Therapy and Hyperthermia in Treating Patients With Stage II, Stage III, or Stage IV Cervical Cancer
Feasibility Study of the Combination of Radiotherapy, Chemotherapy and Hyperthermia for the Treatment of Stage IIB-III-IVA Cervical Cancer
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
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Amsterdam, Netherlands, 1105 AZ
- Academisch Medisch Centrum
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Rotterdam, Netherlands, 3075 EA
- Rotterdam Cancer Institute
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Rotterdam, Netherlands, 3000 CA
- University Hospital - Rotterdam Dijkzigt
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Utrecht, Netherlands, 3584 CX
- Academisch Ziekenhuis Utrecht
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
Collaborators and Investigators
Investigators
- Study Chair: Anneke M. Westermann, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DUT-KWF-CKVO-2000-02
- CDR0000068376 (REGISTRY: PDQ (Physician Data Query))
- EU-20036
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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