Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002577
Status:
COMPLETED
Last Update Posted:
2013-11-19
First Post:
1999-11-01
Brief Title:
Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A PHASE III DOSE ESCALATION STUDY USING THREE DIMENSIONAL CONFORMAL RADIATION THERAPY POST INDUCTION CHEMOTHERAPY IN PATIENTS WITH LOCALLY ADVANCED INOPERABLE NON-SMALL CELL LUNG CANCER
Status:
COMPLETED
Status Verified Date:
2013-11
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 Radiation therapy uses high-energy x-rays to damage tumor cells
PURPOSE Phase III trial to study the effectiveness of radiation therapy in treating patients with non-small cell lung cancer that cannot be surgically removed
PURPOSE Phase III trial to study the effectiveness of radiation therapy in treating patients with non-small cell lung cancer that cannot be surgically removed
Detailed Description:
OBJECTIVES I Assess the treatment related morbidity associated with escalating doses of 3-dimensional conformal radiotherapy 3D-CRT in patients with locally advanced inoperable non-small cell lung cancer II Determine the maximum tolerated dose of 3D-CRT in these patients III Evaluate the morbidity associated with high dose 3D-CRT for carcinoma of the lung
OUTLINE This is a dose escalation study Patients are stratified by the percentage of total lung volume TLV receiving greater than 20 Gy of radiation less than 25 vs 25 to less than 37 vs at least 37 As of 711999 the third stratum closed to accrual Patients receive 3-dimensional conformal radiotherapy 3D-CRT 5 days a week for either 6-7 weeks 7-8 weeks or 9-10 weeks depending on the cohort Within each TLV stratum cohorts of 15-36 patients receive escalating doses of 3D-CRT until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which less than 15 of patients experience dose limiting toxicity Patients are followed every 3 months for 1 year every 4 months for 1 year every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 15-36 patients per cohort will be accrued for this study within 1 year As of 711999 the third stratum closed to accrual
OUTLINE This is a dose escalation study Patients are stratified by the percentage of total lung volume TLV receiving greater than 20 Gy of radiation less than 25 vs 25 to less than 37 vs at least 37 As of 711999 the third stratum closed to accrual Patients receive 3-dimensional conformal radiotherapy 3D-CRT 5 days a week for either 6-7 weeks 7-8 weeks or 9-10 weeks depending on the cohort Within each TLV stratum cohorts of 15-36 patients receive escalating doses of 3D-CRT until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which less than 15 of patients experience dose limiting toxicity Patients are followed every 3 months for 1 year every 4 months for 1 year every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 15-36 patients per cohort will be accrued for this study within 1 year As of 711999 the third stratum closed to accrual
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 |
|---|---|---|---|
| CDR0000063662 | None | None | None |