Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002503
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
1999-11-01
Brief Title:
Strontium Compared With Radiation Therapy in Treating Patients With Hormone-Refractory Prostate Cancer With Painful Bone Metastases
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
A PROSPECTIVE MULTICENTER RANDOMIZED STUDY COMPARING STRONTIUM-89 CHLORIDE AND PALLIATIVE LOCAL FIELD RADIOTHERAPY IN PATIENTS WITH HORMONAL ESCAPED ADVANCED PROSTATIC CANCER
Status:
COMPLETED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EORTC-30921 | None | None | None |