Ignite Creation Date:
2025-12-18 @ 8:20 AM
Ignite Modification Date:
2025-12-23 @ 9:49 PM
Study NCT ID:
NCT00572923
Status:
None
Last Update Posted:
2009-06-17 00:00:00
First Post:
2007-12-12 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Concurrent Chemo-Radiotherapy for Limited Disease Small Cell Lung Cancer (LD-SCLC) on Basis of FDG-PET-Scans
Sponsor:
None
Organization:
Study Overview
Official Title:
Concurrent Chemo-Radiotherapy for Limited Disease Small Cell Lung Cancer (LD-SCLC) on Basis of FDG-PET-Scans
Status:
None
Status Verified Date:
2009-06
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:
BRONC 45 15
Brief Summary:
Eligible patients (see below) will receive radiotherapy to the primary tumor and the initially involved mediastinal lymph nodes on FDG-PET scan to a dose of 45 Gy in 30 fractions in 3 weeks (1.5 Gy BID with minimum 6 h interfraction interval).
Dose-constraints: MLD \> 20 Gy. In that case, CT-based replanning will be done after 1 week of treatment and shrinking field techniques will be used if appropriate.
The radiation doses will be specified according to ICRU 50. Lung density corrections will be applied, as well as all standard QA procedures. Technical requirements are the same as in standard practice at MAASTRO clinic.
Radiotherapy shall start during the first cycle of carboplatin and etoposide chemotherapy.
Chemotherapy (standard schedule in the Comprehensive Cancer Centre Limburg region):
* carboplatin AUC 5 day 1
* etoposide 120 mg/m2 days 1-3
Q 3 weeks; 5 cycles
In patients with no progression and a WHO PS 0-2, after the completion of chemotherapy, PCI will be given (25 Gy in 10 fractions, QD)
Dose-constraints: MLD \> 20 Gy. In that case, CT-based replanning will be done after 1 week of treatment and shrinking field techniques will be used if appropriate.
The radiation doses will be specified according to ICRU 50. Lung density corrections will be applied, as well as all standard QA procedures. Technical requirements are the same as in standard practice at MAASTRO clinic.
Radiotherapy shall start during the first cycle of carboplatin and etoposide chemotherapy.
Chemotherapy (standard schedule in the Comprehensive Cancer Centre Limburg region):
* carboplatin AUC 5 day 1
* etoposide 120 mg/m2 days 1-3
Q 3 weeks; 5 cycles
In patients with no progression and a WHO PS 0-2, after the completion of chemotherapy, PCI will be given (25 Gy in 10 fractions, QD)
Detailed Description:
None
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?: