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Home > "C" Clinical Trials Conditions > Cisplatin Combined with Radiation Therapy and Hyperthermia in Treating Patients With Stage II, Stage III, or Stage IV Cervical Cancer  Cisplatin Combined with Radiation Therapy and Hyperthermia in Treating Patients With Stage II, Stage III, or Stage IV Cervical Cancer
Cisplatin Combined with Radiation Therapy and Hyperthermia in Treating Patients With Stage II, Stage III, or Stage IV Cervical Cancer
For Condition: cervical squamous cell carcinoma,cervical adenocarcinoma,cervical adenosquamous cell carcinoma,stage 2B cervical cancer,stage 3 cervical cancer,stage 4A cervical cancer
Status: No longer recruiting
Sponsor(s): Academisch Medisch Centrum ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AnnekeWestermann, Study Chair, Academisch Medisch Centrum
University Hospital - Rotterdam Dijkzigt
Rotterdam, , 3000 CA
Netherlands
Academisch Medisch Centrum
Amsterdam, , 1105 AZ
Netherlands
Academisch Ziekenhuis Utrecht
Utrecht, , 3584 CX
Netherlands
Rotterdam Cancer Institute
Rotterdam, , 3075 EA
Netherlands
Additional Information:
Study ID Numbers: CDR0000068376; EU-20036,DUT-KWF-CKVO-2000-02
Study Start Date: June 2000
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00008112
Other Cervical Squamous Cell Carcinoma Studies:
1. Gemcitabine in Treating Patients With Persistent or Recurrent Cancer of the Cervix
2. Interleukin-12 in Treating Patients With Advanced or Recurrent Cancer of the Cervix
3. Lymph Node Mapping and Sentinel Lymph Node Identification in Patients With Stage IB1 Cervical Cancer
4. Comparison of Three Chemotherapy Regimens in Treating Patients With Stage IVB, Recurrent, or Persistent Cervical Cancer
5. EF5 to Detect Tumor Hypoxia in Patients With Stage IIB, Stage IIIB, or Stage IVA Cervical Cancer
Related Studies:
Other cervical squamous cell carcinoma Clinical Trials
Other Clinical Trials
Other Rotterdam Clinical Trials
Cisplatin Combined with Radiation Therapy and Hyperthermia in Treating Patients With Stage II, Stage III, or Stage IV Cervical Cancer
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