Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002484
Status:
COMPLETED
Last Update Posted:
2013-11-01
First Post:
1999-11-01
Brief Title:
Radiation Therapy Using 3-Dimensional Treatment Planning in Patients With Non-small Cell Lung Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A PHASE I TRIAL OF DOSE ESCALATION OF EXTERNAL BEAM RADIATION THERAPY USING CONFORMAL 3-DIMENSIONAL TREATMENT PLANNING FOR NON-SMALL CELL LUNG CANCER
Status:
COMPLETED
Status Verified Date:
2013-10
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:
RATIONALE Radiation therapy uses high-energy x-rays to damage tumor cells Computer systems that allow doctors to create a 3-dimensional picture of the tumor in order to plan treatment may result in more effective radiation therapy
PURPOSE Phase I trial to study the effectiveness of high-dose radiation therapy planned using a 3-dimensional picture of the tumor in treating patients who have stage I stage II or stage III non-small cell lung cancer
PURPOSE Phase I trial to study the effectiveness of high-dose radiation therapy planned using a 3-dimensional picture of the tumor in treating patients who have stage I stage II or stage III non-small cell lung cancer
Detailed Description:
OBJECTIVES
Determine the maximum dose of external beam irradiation deliverable using conformal 3-dimensional treatment planning in patients with non-small cell lung cancer
Determine the feasibility and efficacy of 3-dimensional treatment planning in delivering high doses of external beam radiotherapy to these patients
Determine whether computer-generated dose-volume histograms and normal tissue complication probability models can predict the degree of pulmonary toxicity resulting from external beam radiotherapy
Determine the relationship between dose of external beam radiotherapy and the degree of pulmonary function change
OUTLINE This is a dose escalation study
Patients undergo 3-dimensional conformal external beam radiotherapy 5 days a week for 8-10 weeks
Cohorts of 10 patients receive escalating doses of radiotherapy until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 20 of patients experience dose-limiting toxicity
Patients are followed at 1 month and then every 4 months thereafter
PROJECTED ACCRUAL A total of 60-70 patients will be accrued for this study within 3 years
Determine the maximum dose of external beam irradiation deliverable using conformal 3-dimensional treatment planning in patients with non-small cell lung cancer
Determine the feasibility and efficacy of 3-dimensional treatment planning in delivering high doses of external beam radiotherapy to these patients
Determine whether computer-generated dose-volume histograms and normal tissue complication probability models can predict the degree of pulmonary toxicity resulting from external beam radiotherapy
Determine the relationship between dose of external beam radiotherapy and the degree of pulmonary function change
OUTLINE This is a dose escalation study
Patients undergo 3-dimensional conformal external beam radiotherapy 5 days a week for 8-10 weeks
Cohorts of 10 patients receive escalating doses of radiotherapy until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 20 of patients experience dose-limiting toxicity
Patients are followed at 1 month and then every 4 months thereafter
PROJECTED ACCRUAL A total of 60-70 patients will be accrued for this study within 3 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 |
|---|---|---|---|
| NCI-V91-0198 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000077300 | REGISTRY | None | None |