Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00062335
Status:
TERMINATED
Last Update Posted:
2012-09-24
First Post:
2003-06-05
Brief Title:
High-Dose 3-Dimensional Conformal Radiation Therapy in Treating Patients With Inoperable Stage I Stage II or Stage IIIA Non-Small Cell Lung Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
A Phase I Study On The Feasibility Of High Dose Three Dimensional Conformal Radiotherapy In Patients With Inoperable And Locally Advanced Non Small Cell Lung Cancer
Status:
TERMINATED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Using computer systems that create a 3-dimensional picture of the tumor to plan treatment may enable doctors to provide more effective radiation therapy that will cause less damage to normal tissue
PURPOSE This phase I trial is studying the side effects and best dose of high-dose 3-dimensional conformal radiation therapy in treating patients with inoperable stage I stage II or stage IIIA non-small cell lung cancer
PURPOSE This phase I trial is studying the side effects and best dose of high-dose 3-dimensional conformal radiation therapy in treating patients with inoperable stage I stage II or stage IIIA non-small cell lung cancer
Detailed Description:
OBJECTIVES
Determine the optimal dose of high-dose 3-dimensional conformal radiotherapy in patients with inoperable stage I II or IIIA non-small cell lung cancer who are treated according to the total lung volume irradiated
Determine the feasibility of this regimen in terms of local control rates and incidence of distant metastases in these patients
OUTLINE This is an open-label nonrandomized dose-escalation multicenter study Patients are assigned to 1 of 3 strata according to the total lung volume irradiated less than 25 vs 25-37 vs over 37
Stratum I Patients undergo high-dose 3-dimensional 3-D conformal radiotherapy 5 days a week for 6 weeks
Stratum II Patients undergo high-dose 3-D conformal radiotherapy 5 days a week for 55-7 weeks
Stratum III Patients undergo high-dose 3-D conformal radiotherapy 5 days a week for 55-65 weeks
Cohorts of 6-15 patients in each stratum receive escalating dose intensities of high-dose 3-D conformal radiotherapy either by increasing the total dose or by shortening treatment time until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 6 2 of 15 or 3 of 30 patients experience dose-limiting toxicity
Patients are followed at 1 month at least every 2 months for 1 year every 3 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL A total of 54-135 patients 18-45 per stratum will be accrued for this study
Determine the optimal dose of high-dose 3-dimensional conformal radiotherapy in patients with inoperable stage I II or IIIA non-small cell lung cancer who are treated according to the total lung volume irradiated
Determine the feasibility of this regimen in terms of local control rates and incidence of distant metastases in these patients
OUTLINE This is an open-label nonrandomized dose-escalation multicenter study Patients are assigned to 1 of 3 strata according to the total lung volume irradiated less than 25 vs 25-37 vs over 37
Stratum I Patients undergo high-dose 3-dimensional 3-D conformal radiotherapy 5 days a week for 6 weeks
Stratum II Patients undergo high-dose 3-D conformal radiotherapy 5 days a week for 55-7 weeks
Stratum III Patients undergo high-dose 3-D conformal radiotherapy 5 days a week for 55-65 weeks
Cohorts of 6-15 patients in each stratum receive escalating dose intensities of high-dose 3-D conformal radiotherapy either by increasing the total dose or by shortening treatment time until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 6 2 of 15 or 3 of 30 patients experience dose-limiting toxicity
Patients are followed at 1 month at least every 2 months for 1 year every 3 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL A total of 54-135 patients 18-45 per stratum will be accrued for this study
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 |
|---|---|---|---|
| EORTC-22994 | None | None | None |