Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00482807
Status:
COMPLETED
Last Update Posted:
2023-11-24
First Post:
2007-06-04
Brief Title:
Radiation Therapy Docetaxel and Hormone Therapy in High-Risk Locally Advanced Metastasized Prostate Cancer
Sponsor:
University of Nebraska
Organization:
University of Nebraska
Study Overview
Official Title:
Phase I Study Evaluating Extended Field Intensity Modulated Radiation Therapy and Docetaxel in Patients With Prostate Cancer Associated With Pelvic Node Metastasis
Status:
COMPLETED
Status Verified Date:
2023-11
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 Specialized radiation therapy that delivers a high- dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue Drugs used in chemotherapy such as docetaxel work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Androgens can cause the growth of prostate cancer cells Antihormone therapy such as goserelin and bicalutamide may lessen the amount of androgens made by the body Giving radiation therapy together with chemotherapy and hormone therapy may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of docetaxel when given together with intensity-modulated radiation therapy and hormone therapy in treating patients with high-risk locally advanced prostate cancer with pelvic lymph node metastasis
PURPOSE This phase I trial is studying the side effects and best dose of docetaxel when given together with intensity-modulated radiation therapy and hormone therapy in treating patients with high-risk locally advanced prostate cancer with pelvic lymph node metastasis
Detailed Description:
OBJECTIVES
Primary
Determine preliminarily the grade III or IV toxicity rate of concurrent extended-field intensity-modulated radiotherapy IMRT docetaxel and androgen deprivation therapy in patients with high-risk locally advanced prostate cancer with pelvic lymph node metastasis
Secondary
Determine preliminarily the progression-free survival of patients treated with this regimen
Determine the maximum tolerated dose of docetaxel when administered with concurrent IMRT in this patients
OUTLINE This is a dose-escalation study of docetaxel
Patients receive combined androgen deprivation therapy if not already on combined hormonal therapy comprising goserelin acetate subcutaneously once every 3 months for up to 2 years and oral bicalutamide once daily beginning on day 1 and continuing until the completion of radiotherapy Beginning at approximately week 9 of androgen deprivation therapy patients receive docetaxel IV over 1 hour once weekly for up to 9 weeks Concurrently with chemotherapy patients undergo intensity-modulated radiotherapy 5 days a week for up to 45 fractions 9 weeks
Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Note Not required for patients who have undergone bilateral orchiectomy
After completion of study therapy patients are followed periodically for 5 years
Primary
Determine preliminarily the grade III or IV toxicity rate of concurrent extended-field intensity-modulated radiotherapy IMRT docetaxel and androgen deprivation therapy in patients with high-risk locally advanced prostate cancer with pelvic lymph node metastasis
Secondary
Determine preliminarily the progression-free survival of patients treated with this regimen
Determine the maximum tolerated dose of docetaxel when administered with concurrent IMRT in this patients
OUTLINE This is a dose-escalation study of docetaxel
Patients receive combined androgen deprivation therapy if not already on combined hormonal therapy comprising goserelin acetate subcutaneously once every 3 months for up to 2 years and oral bicalutamide once daily beginning on day 1 and continuing until the completion of radiotherapy Beginning at approximately week 9 of androgen deprivation therapy patients receive docetaxel IV over 1 hour once weekly for up to 9 weeks Concurrently with chemotherapy patients undergo intensity-modulated radiotherapy 5 days a week for up to 45 fractions 9 weeks
Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Note Not required for patients who have undergone bilateral orchiectomy
After completion of study therapy patients are followed periodically for 5 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 |
|---|---|---|---|
| P30CA036727 | NIH | None | httpsreporternihgovquickSearchP30CA036727 |