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Hyperthermia Plus Radiation Therapy in Treating Patients With Nonmetastatic Advanced Prostate Cancer
This study is ongoing, but not recruiting participants.
Study NCT00003045   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes

November 1, 1999
February 6, 2009
April 1997
 
 
 
Complete list of historical versions of study NCT00003045 on ClinicalTrials.gov Archive Site
 
 
 
Hyperthermia Plus Radiation Therapy in Treating Patients With Nonmetastatic Advanced Prostate Cancer
A Phase II Trial of Hyperthermia and Radiotherapy for Locally Advanced Adenocarcinoma of the Prostate

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.

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.

Phase II
Interventional
Treatment
Prostate Cancer
  • Procedure: hyperthermia treatment
  • Radiation: radiation therapy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
65
 
 

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003045
 
CDR0000065679, DFCI-94153, NCI-H97-1294
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Study Chair: Mark Hurwitz, MD Dana-Farber Cancer Institute
National Cancer Institute (NCI)
November 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP