Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00115518
Status:
COMPLETED
Last Update Posted:
2011-08-05
First Post:
2005-06-22
Brief Title:
Radiation Plus Cetuximab in Locally Advanced Non-Small Cell Lung Cancer NSCLC
Sponsor:
Heidelberg University
Organization:
Heidelberg University
Study Overview
Official Title:
Locoregional Radiotherapy in Combination With Cetuximab in Inoperable Non-Small Cell Lung Cancer Stage III
Status:
COMPLETED
Status Verified Date:
2011-02
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:
The purpose of this trial is to study combined locoregional radiotherapy with cetuximab in non-operable NSCLC Stage III Phase II trial
Endpoints
safety and feasibility primary response survival time to progression secondary
Endpoints
safety and feasibility primary response survival time to progression secondary
Detailed Description:
Study entry examinations
blood cell count
liver enzymes
ventilatory function test
pregnancy test premenopausal women
CT of the thorax
CT of the brain
Ultrasound of the liver
Bone scan
FDG PET scan after inclusion
Follow-up examinations 2 months than every 3 months
patients history and examination
CT scan of the thorax
ventilatory functions test
FDG PET scan at least at 6 months
bone scan yearly
ultrasound of the liver every 6 months
Cetuximab administration
450 mg m2 body surface on week 1
250 mg m2 body surface weekly week 2 -21
Radiation therapy
intensity modulated radiation therapy of primary tumor and mediastinum 2 Gy single dose total dose 50 Gy 5 fractions per week with boost to the PET positive sites 2 Gy single doses up to 66 Gy Radiation therapy during weeks 2-8
Amendment 107 3D conformal RT possible but not if FeV1 15L of 50
blood cell count
liver enzymes
ventilatory function test
pregnancy test premenopausal women
CT of the thorax
CT of the brain
Ultrasound of the liver
Bone scan
FDG PET scan after inclusion
Follow-up examinations 2 months than every 3 months
patients history and examination
CT scan of the thorax
ventilatory functions test
FDG PET scan at least at 6 months
bone scan yearly
ultrasound of the liver every 6 months
Cetuximab administration
450 mg m2 body surface on week 1
250 mg m2 body surface weekly week 2 -21
Radiation therapy
intensity modulated radiation therapy of primary tumor and mediastinum 2 Gy single dose total dose 50 Gy 5 fractions per week with boost to the PET positive sites 2 Gy single doses up to 66 Gy Radiation therapy during weeks 2-8
Amendment 107 3D conformal RT possible but not if FeV1 15L of 50
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