Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00124917
Status:
TERMINATED
Last Update Posted:
2019-09-13
First Post:
2005-07-27
Brief Title:
Phase I Study of Intensity Modulated Radiation Therapy for Prostate Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase I Study of Image Guided Dose Escalation With Intensity Modulated Radiation Therapy IMRT to Histologically Confirmed Regions of Prostate Cancer
Status:
TERMINATED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study closed due to unanticipated toxicityrisks to subjects
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
BACKGROUND
-This study represents a progression from findings in four previous National Cancer Institute NCI Radiation Oncology Branch ROB protocols 02-C-0167A 02-C-0207E 03-C-0190B 04-C-0171 In these previous works we have begun to develop techniques to obtain magnetic resonance MR biological images and co-register tissue in prostate cancer patients
OBJECTIVES
-The scientific objective of this protocol is to determine the maximum tolerated dose MTD of external beam radiation to regions of interest within the prostate based acute toxicity
Secondary objectives of this study are to relate patterns in gene and protein expression to response and toxicity and to evaluate the frequency of late term toxicity
ELIGIBILITY
-Patients with prostate cancer without evidence of metastasis will be eligible for this study
DESIGN
This phase I trial will use intensity modulated radiation therapy IMRT to deliver escalating doses of external beam radiation to regions of histologically confirmed prostate cancer The study will be conducted using a standard 3-6 dose-escalation with an initial 3 patients in each dose cohort and the potential expansion of the cohort to 6 patients
Anatomic magnetic resonance imaging MRI and magnetic resonance MR biological images such as magnetic resonance spectroscopy MRS will be obtained Tissue will be acquired from sites of interest with biopsy locations precisely translated co-registered to an MR image of reference Tissue samples will be processed for complementary deoxyribonucleic acid cDNA microarray testing and stored for future analysis in the Radiation Oncology Branch NCI A gold seed will be left at the biopsy site as a fiducial marker to direct future radiation therapy If necessary additional fiducial markers will be placed for target localization during treatment
Once MR guided biopsies are obtained and fiducial markers placed the patient will undergo a standard computed tomography CT simulation for radiation therapy treatment planning The MR and CT images will be fused Areas of pathologically confirmed malignancy will undergo dose escalation as described below Areas of image abnormality that could not be biopsied or were without definite pathologic evidence of malignancy will be given intermediate doses The remainder of the prostate gland will receive standard dose 7560 centigray cGy
The trial will accrue 18 to 36 patients with an anticipated accrual period of 2 years
-This study represents a progression from findings in four previous National Cancer Institute NCI Radiation Oncology Branch ROB protocols 02-C-0167A 02-C-0207E 03-C-0190B 04-C-0171 In these previous works we have begun to develop techniques to obtain magnetic resonance MR biological images and co-register tissue in prostate cancer patients
OBJECTIVES
-The scientific objective of this protocol is to determine the maximum tolerated dose MTD of external beam radiation to regions of interest within the prostate based acute toxicity
Secondary objectives of this study are to relate patterns in gene and protein expression to response and toxicity and to evaluate the frequency of late term toxicity
ELIGIBILITY
-Patients with prostate cancer without evidence of metastasis will be eligible for this study
DESIGN
This phase I trial will use intensity modulated radiation therapy IMRT to deliver escalating doses of external beam radiation to regions of histologically confirmed prostate cancer The study will be conducted using a standard 3-6 dose-escalation with an initial 3 patients in each dose cohort and the potential expansion of the cohort to 6 patients
Anatomic magnetic resonance imaging MRI and magnetic resonance MR biological images such as magnetic resonance spectroscopy MRS will be obtained Tissue will be acquired from sites of interest with biopsy locations precisely translated co-registered to an MR image of reference Tissue samples will be processed for complementary deoxyribonucleic acid cDNA microarray testing and stored for future analysis in the Radiation Oncology Branch NCI A gold seed will be left at the biopsy site as a fiducial marker to direct future radiation therapy If necessary additional fiducial markers will be placed for target localization during treatment
Once MR guided biopsies are obtained and fiducial markers placed the patient will undergo a standard computed tomography CT simulation for radiation therapy treatment planning The MR and CT images will be fused Areas of pathologically confirmed malignancy will undergo dose escalation as described below Areas of image abnormality that could not be biopsied or were without definite pathologic evidence of malignancy will be given intermediate doses The remainder of the prostate gland will receive standard dose 7560 centigray cGy
The trial will accrue 18 to 36 patients with an anticipated accrual period of 2 years
Detailed Description:
BACKGROUND
-This study represents a progression from findings in four previous National Cancer Institute NCI Radiation Oncology Branch ROB protocols 02-C-0167A 02-C-0207E 03-C-0190B 04-C-0171 In these previous works we have begun to develop techniques to obtain magnetic resonance MR biological images and co-register tissue in prostate cancer patients
OBJECTIVES
The scientific objective of this protocol is to determine the maximum tolerated dose MTD of external beam radiation to regions of interest within the prostate based acute toxicity
Secondary objectives of this study are to relate patterns in gene and protein expression to response and toxicity and to evaluate the frequency of late term toxicity
ELIGIBILITY
-Patients with prostate cancer without evidence of metastasis will be eligible for this study
DESIGN
This phase I trial will use intensity modulated radiation therapy IMRT to deliver escalating doses of external beam radiation to regions of histologically confirmed prostate cancer The study will be conducted using a standard 3-6 dose-escalation with an initial 3 patients in each dose cohort and the potential expansion of the cohort to 6 patients
Anatomic magnetic resonance imaging MRI and MR biological images such as magnetic resonance spectroscopy MRS will be obtained Tissue will be acquired from sites of interest with biopsy locations precisely translated co-registered to an MR image of reference Tissue samples will be processed for complementary deoxyribonucleic acid cDNA microarray testing and stored for future analysis in the Radiation Oncology Branch NCI A gold seed will be left at the biopsy site as a fiducial marker to direct future radiation therapy If necessary additional fiducial markers will be placed for target localization during treatment
Once MR guided biopsies are obtained and fiducial markers placed the patient will undergo a standard computed tomography CT simulation for radiation therapy treatment planning The MR and CT images will be fused Areas of pathologically confirmed malignancy will undergo dose escalation as described below Areas of image abnormality that could not be biopsied or were without definite pathologic evidence of malignancy will be given intermediate doses The remainder of the prostate gland will receive standard dose 7560 centigray cGy
The trial will accrue 18 to 36 patients with an anticipated accrual period of 2 years
-This study represents a progression from findings in four previous National Cancer Institute NCI Radiation Oncology Branch ROB protocols 02-C-0167A 02-C-0207E 03-C-0190B 04-C-0171 In these previous works we have begun to develop techniques to obtain magnetic resonance MR biological images and co-register tissue in prostate cancer patients
OBJECTIVES
The scientific objective of this protocol is to determine the maximum tolerated dose MTD of external beam radiation to regions of interest within the prostate based acute toxicity
Secondary objectives of this study are to relate patterns in gene and protein expression to response and toxicity and to evaluate the frequency of late term toxicity
ELIGIBILITY
-Patients with prostate cancer without evidence of metastasis will be eligible for this study
DESIGN
This phase I trial will use intensity modulated radiation therapy IMRT to deliver escalating doses of external beam radiation to regions of histologically confirmed prostate cancer The study will be conducted using a standard 3-6 dose-escalation with an initial 3 patients in each dose cohort and the potential expansion of the cohort to 6 patients
Anatomic magnetic resonance imaging MRI and MR biological images such as magnetic resonance spectroscopy MRS will be obtained Tissue will be acquired from sites of interest with biopsy locations precisely translated co-registered to an MR image of reference Tissue samples will be processed for complementary deoxyribonucleic acid cDNA microarray testing and stored for future analysis in the Radiation Oncology Branch NCI A gold seed will be left at the biopsy site as a fiducial marker to direct future radiation therapy If necessary additional fiducial markers will be placed for target localization during treatment
Once MR guided biopsies are obtained and fiducial markers placed the patient will undergo a standard computed tomography CT simulation for radiation therapy treatment planning The MR and CT images will be fused Areas of pathologically confirmed malignancy will undergo dose escalation as described below Areas of image abnormality that could not be biopsied or were without definite pathologic evidence of malignancy will be given intermediate doses The remainder of the prostate gland will receive standard dose 7560 centigray cGy
The trial will accrue 18 to 36 patients with an anticipated accrual period of 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 05-C-0191 | None | None | None |