Hyperthermia Plus Radiation Therapy in Treating Patients With Nonmetastatic Advanced Prostate Cancer
This trial is active, not recruiting.
|Treatments||hyperthermia treatment, radiation therapy|
|Sponsor||Dana-Farber Cancer Institute|
|Collaborator||National Cancer Institute (NCI)|
|Start date||April 1997|
|Trial size||65 participants|
|Trial identifier||NCT00003045, CDR0000065679, DFCI-94153, NCI-H97-1294|
RATIONALE: Hyperthermia therapy may kill prostate cancer cells by heating them to several degrees above body temperature. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining hyperthermia with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of hyperthermia plus radiation therapy in treating patients who have nonmetastatic advanced prostate cancer.
Male participants at least 18 years old.
DISEASE CHARACTERISTICS: - Histologically proven prostate cancer; stage T2a, T2b, or T3a disease as defined by 1997 (current) AJCC criteria - No metastatic disease PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-1 Life expectancy: - At least 5 years unless due to prostate cancer Hematopoietic: - WBC greater than 4000/mm3 - Platelet count greater than 100,000/mm3 - Hematocrit greater than 30% Hepatic: - Not specified Renal: - Not specified Cardiovascular: - No myocardial infarction within past 6 months - No unstable angina pectoris with medication - Diastolic BP no greater than 100 mm Hg - No pacemaker - No congestive heart failure requiring medication - No evidence of vasculopathy Neurologic: - No evidence of neuropathy Pulmonary: - No severe chronic obstructive pulmonary disease (FEV1 less than 50% of predicted or less than 1 liter) Other: - No prior or concurrent malignancy except nonmelanoma skin cancer - No severe, insulin dependent diabetes mellitus - No severe cerebrovascular disease PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy Endocrine therapy: - Up to 2 months of prior neoadjuvant hormonal therapy allowed Radiotherapy: - No prior pelvic radiotherapy Surgery: - Not specified Other: - No anti-arrhythmic drugs
|Official title||A Phase II Trial of Hyperthermia and Radiotherapy for Locally Advanced Adenocarcinoma of the Prostate|
|Description||OBJECTIVES: - Evaluate the efficacy of hyperthermia and radiation therapy in patients with locally advanced prostate cancer. - Evaluate the acute and long term toxicities of these therapies in this patient population. OUTLINE: Patients are treated with external beam irradiation 5 days a week for a total of approximately 7 weeks. Hyperthermia treatment is given twice in the first 4 weeks of radiation therapy, preferably early in the course of radiation. Hyperthermia treatments are only given once a week. A transrectal ultrasound applicator is used to deliver the hyperthermia treatment. Patients are followed every three months for 2 years, and every 6 months thereafter. PROJECTED ACCRUAL: Approximately 65 patients will be accrued over 2 years.|
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