Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006365
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2000-10-04
Brief Title:
External-Beam Radiation Therapy Plus Implanted Radiation Therapy in Treating Patients With Prostate Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Phase II Study of External Beam Radiation Therapy Combined With Permanent Source Brachytherapy for Intermediate Risk Clinically Localized Adenocarcinoma of the Prostate
Status:
COMPLETED
Status Verified Date:
2014-01
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 Radiation therapy uses high-energy x-rays and other sources to damage tumor cells Giving radiation therapy in different ways may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of external-beam radiation therapy followed by implanted radiation therapy in treating patients who have prostate cancer
PURPOSE Phase II trial to study the effectiveness of external-beam radiation therapy followed by implanted radiation therapy in treating patients who have prostate cancer
Detailed Description:
OBJECTIVES I Determine the acute and late grade 3-5 genitourinary GU and gastrointestinal GI toxic effects of external beam radiotherapy followed by permanent source brachytherapy using interstitial iodine I 125 seeds in patients with intermediate risk clinically localized adenocarcinoma of the prostate II Determine the freedom from prostate specific antigen PSA failure overall survival disease specific survival and local andor distant clinical relapse rates in patients treated with this regimen
OUTLINE This is a multicenter study Patients undergo external beam radiotherapy EBRT to the pelvis 5 days a week for 5 weeks Permanent source brachytherapy comprised of ultrasound-guided implantation of iodine I 125 seeds into the prostate is performed 2-6 weeks after completion of EBRT Patients are followed at 1 3 6 9 and 12 months then every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 110 patients will be accrued for this study within 1 year
OUTLINE This is a multicenter study Patients undergo external beam radiotherapy EBRT to the pelvis 5 days a week for 5 weeks Permanent source brachytherapy comprised of ultrasound-guided implantation of iodine I 125 seeds into the prostate is performed 2-6 weeks after completion of EBRT Patients are followed at 1 3 6 9 and 12 months then every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 110 patients will be accrued for this study within 1 year
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 |
|---|---|---|---|
| CDR0000068238 | None | None | None |