Concurrent Chemo-Radiotherapy for Limited Disease Small Cell Lung Cancer (LD-SCLC) on Basis of FDG-PET-Scans (BRONC 45 15)
|ClinicalTrials.gov Identifier: NCT00572923|
Recruitment Status : Completed
First Posted : December 13, 2007
Last Update Posted : June 17, 2009
|Condition or disease|
|Small Cell Lung Cancer|
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)
|Study Type :||Observational|
|Estimated Enrollment :||52 participants|
|Official Title:||Concurrent Chemo-Radiotherapy for Limited Disease Small Cell Lung Cancer (LD-SCLC) on Basis of FDG-PET-Scans|
|Study Start Date :||August 2006|
|Actual Study Completion Date :||February 2009|
- isolated Nodal Recurrences [ Time Frame: 18 months post-treatment ]
- overall survival [ Time Frame: 18 months post-treatment ]
- progression-free interval [ Time Frame: 18 months post-treatment ]
- dyspnea (CTCAE 3.0) [ Time Frame: 18 months post-treatment ]
- dysphagia (CTCAE 3.0) [ Time Frame: 18 months post-treatment ]
- patterns of recurrence [ Time Frame: 18 months post-treatment ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00572923
|MAASTRO clinic, Maastricht Radiation Oncology|
|Maastricht, Netherlands, 6202 AZ|
|Principal Investigator:||Dirk De Ruysscher, MD,PhD||MAASTRO clinic, Maastricht Radiation Oncology|