Feasibility Study of the Combination of Radiotherapy, Chemotherapy and Hyperthermia for the Treatment of Stage IIB-III-IVA Cervical Cancer
试验速览
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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:
- •18 and over
- •Performance status:
- •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
- •Not specified
- •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
- •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
- •No prior surgery
排除标准
- 未提供