Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00394511
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
2006-10-31
Brief Title:
Radiation Therapy After Prostatectomy in Treating Patients With Stage III Prostate Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Randomized Evaluation of Adjuvant Radiotherapy vs No Adjuvant Therapy Following Radical Prostatectomy and Pelvic Lymphadenectomy in Surgical Stage C Adenocarcinoma of the Prostate
Status:
COMPLETED
Status Verified Date:
2006-10
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:
Randomized phase III trial to compare treatment with or without adjuvant radiation therapy in men with stage III prostate cancer who have had radical prostatectomy and lymphadenectomy recently Radiation therapy uses high-energy x-rays to damage tumor cells and may be an effective treatment for prostate cancer
Detailed Description:
OBJECTIVES
I Compare disease-free survival rates of patients randomly assigned to adjuvant external-beam radiotherapy vs no adjuvant therapy following radical prostatectomy and pelvic lymphadenectomy for surgical Stage C T3 N0 M0 adenocarcinoma of the prostate
II Determine the qualitative and quantitative toxicities associated with this adjuvant therapy
OUTLINE Randomized study Randomization takes place when the patient is physically able to begin treatment any time within 16 weeks after surgery
Arm I Radiotherapy Irradiation of the prostatic bed using megavoltage equipment with effective photon energies of greater than 4 MV
Arm II No further treatment
I Compare disease-free survival rates of patients randomly assigned to adjuvant external-beam radiotherapy vs no adjuvant therapy following radical prostatectomy and pelvic lymphadenectomy for surgical Stage C T3 N0 M0 adenocarcinoma of the prostate
II Determine the qualitative and quantitative toxicities associated with this adjuvant therapy
OUTLINE Randomized study Randomization takes place when the patient is physically able to begin treatment any time within 16 weeks after surgery
Arm I Radiotherapy Irradiation of the prostatic bed using megavoltage equipment with effective photon energies of greater than 4 MV
Arm II No further treatment
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 |
|---|---|---|---|
| CDR0000075112 | REGISTRY | PDQ Physician Data Query | None |
| SWOG-8794 | None | None | None |
| CAN-NCIC-PR2 | None | None | None |
| CLB-9493 | None | None | None |
| EST-9887 | None | None | None |
| NCCTG-895251 | None | None | None |
| RTOG-9019 | None | None | None |
| INT-0086 | None | None | None |