Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-01-29 @ 12:14 AM
Study NCT ID:
NCT00115518
Status:
COMPLETED
Last Update Posted:
2011-08-05
First Post:
2005-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiation Plus Cetuximab in Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
Sponsor:
Heidelberg University
Organization:
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 / m\^2 body surface on week 1
* 250 mg /m\^2 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 1/07: 3D conformal RT possible, but not if FeV1 \< 1.5L 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 / m\^2 body surface on week 1
* 250 mg /m\^2 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 1/07: 3D conformal RT possible, but not if FeV1 \< 1.5L of \< 50%
Study Oversight
Has Oversight DMC:
False
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?: