Ignite Creation Date:
2024-05-05 @ 9:27 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004054
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
1999-12-10
Brief Title:
Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Phase III Protocol of Androgen Suppression AS and Radiation Therapy RT vs AS and RT Followed by Chemotherapy With Paclitaxel Estramustine and Etoposide TEE for Localized High-Risk Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2017-11
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 Hormones can stimulate the production of prostate cancer cells Hormone therapy may fight prostate cancer by reducing the production of androgens Radiation therapy uses high-energy x-rays to damage tumor cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die It is not yet known whether hormone therapy plus radiation therapy is more effective with or without combination chemotherapy for prostate cancer
PURPOSE Randomized phase III trial to compare the effectiveness of hormone therapy plus radiation therapy with or without combination chemotherapy in treating patients who have prostate cancer
PURPOSE Randomized phase III trial to compare the effectiveness of hormone therapy plus radiation therapy with or without combination chemotherapy in treating patients who have prostate cancer
Detailed Description:
OBJECTIVES
Compare the efficacy of androgen suppression and radiotherapy with or without subsequent paclitaxel estramustine and etoposide in terms of overall and disease-free survival biochemical and local control and freedom from distant metastasis in patients with localized high-risk prostate cancer
Compare the toxic effects of these regimens in these patients
OUTLINE This is a randomized study Patients are stratified according to prostate-specific antigen level 10 ngmL vs 11-100 ngmL tumor stage T1-2 vs T3-4 Gleason score 7 vs 8-10 and prior hormone use yes vs no Patients are randomized to one of two treatment arms
All patients receive androgen suppression comprising a luteinizing hormone-releasing hormone LHRH agonist AND bicalutamide OR flutamide for 4 months Beginning 8 weeks after the initiation of androgen suppression all patients undergo radiotherapy once daily 5 days a week for 7-8 weeks Patients who received prior androgen suppression therapy count time to radiotherapy from start date of prior hormonal therapy
Arm I Patients continue androgen suppression therapy LHRH agonist only for approximately 20 more months after radiotherapy is completed
Arm II Patients continue therapy as in arm I and receive chemotherapy beginning 28 days after completing radiotherapy Chemotherapy comprises oral estramustine 3 times daily and oral etoposide twice daily on days 1-14 and paclitaxel IV over 1 hour on day 2 Chemotherapy repeats every 21 days for 4 courses
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 1440 patients will be accrued for this study within 6 years
Compare the efficacy of androgen suppression and radiotherapy with or without subsequent paclitaxel estramustine and etoposide in terms of overall and disease-free survival biochemical and local control and freedom from distant metastasis in patients with localized high-risk prostate cancer
Compare the toxic effects of these regimens in these patients
OUTLINE This is a randomized study Patients are stratified according to prostate-specific antigen level 10 ngmL vs 11-100 ngmL tumor stage T1-2 vs T3-4 Gleason score 7 vs 8-10 and prior hormone use yes vs no Patients are randomized to one of two treatment arms
All patients receive androgen suppression comprising a luteinizing hormone-releasing hormone LHRH agonist AND bicalutamide OR flutamide for 4 months Beginning 8 weeks after the initiation of androgen suppression all patients undergo radiotherapy once daily 5 days a week for 7-8 weeks Patients who received prior androgen suppression therapy count time to radiotherapy from start date of prior hormonal therapy
Arm I Patients continue androgen suppression therapy LHRH agonist only for approximately 20 more months after radiotherapy is completed
Arm II Patients continue therapy as in arm I and receive chemotherapy beginning 28 days after completing radiotherapy Chemotherapy comprises oral estramustine 3 times daily and oral etoposide twice daily on days 1-14 and paclitaxel IV over 1 hour on day 2 Chemotherapy repeats every 21 days for 4 courses
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 1440 patients will be accrued for this study within 6 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 |
|---|---|---|---|
| CDR0000067250 | None | None | None |