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| Sponsor: | Dana-Farber Cancer Institute |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003045 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Procedure: hyperthermia treatment Radiation: radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase II Trial of Hyperthermia and Radiotherapy for Locally Advanced Adenocarcinoma of the Prostate |
| Estimated Enrollment: | 65 |
| Study Start Date: | April 1997 |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Neurologic:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Joint Center for Radiation Therapy | |
| Boston, Massachusetts, United States, 02215 | |
| Study Chair: | Mark Hurwitz, MD | Dana-Farber Cancer Institute |
More Information
| Study ID Numbers: | CDR0000065679, DFCI-94153, NCI-H97-1294 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003045 History of Changes |
| Health Authority: | United States: Federal Government |
|
adenocarcinoma of the prostate stage II prostate cancer stage III prostate cancer |
|
Neoplasms by Histologic Type Genital Neoplasms, Male Prostatic Diseases Urogenital Neoplasms Body Temperature Changes Genital Diseases, Male Carcinoma |
Fever Signs and Symptoms Neoplasms Neoplasms by Site Adenocarcinoma Prostatic Neoplasms Neoplasms, Glandular and Epithelial |