Trials / Completed
CompletedNCT00002503
Strontium Compared With Radiation Therapy in Treating Patients With Hormone-Refractory Prostate Cancer With Painful Bone Metastases
A PROSPECTIVE MULTICENTER RANDOMIZED STUDY COMPARING STRONTIUM-89 CHLORIDE AND PALLIATIVE LOCAL FIELD RADIOTHERAPY IN PATIENTS WITH HORMONAL ESCAPED ADVANCED PROSTATIC CANCER
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 204 (actual)
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC · Network
- Sex
- Male
- Age
- —
- Healthy volunteers
- Not accepted
Summary
RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. This may be an effective treatment for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of strontium or radiation therapy in treating patients with prostate cancer that is refractory to hormone therapy who have painful bone metastases.
Detailed description
OBJECTIVES: I. Compare, in a randomized Phase III setting, the subjective response rate, time to progression, and survival of patients with hormone-refractory prostate cancer with painful osseous metastases treated with either strontium-89 or palliative local radiotherapy. II. Compare the quality of life achieved on these two regimens. III. Determine the toxicity and morbidity of treatment on these two regimens. IV. Compare the cost effectiveness of these two regimens. OUTLINE: Randomized study. Arm I: Radioisotope therapy. Strontium-89 chloride, Strontium-89. Arm II: Radiotherapy. Involved-field irradiation (equipment unspecified). PROJECTED ACCRUAL: 200 patients will be entered over 2 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | strontium chloride Sr 89 |
Timeline
- Start date
- 1992-10-01
- Primary completion
- 2000-11-01
- First posted
- 2004-05-20
- Last updated
- 2012-09-24
Locations
21 sites across 9 countries: Belgium, Denmark, Italy, Netherlands, Poland, Portugal, Russia, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT00002503. Inclusion in this directory is not an endorsement.