Concurrent Chemo-radiotherapy With Intensity-Modulated Radiation Therapy (IMRT) for Limited Disease Small Cell Lung Cancer (LD-SCLC)
The investigators' group was the first to perform a phase II trial in patients with limited disease (stage I-III) small-cell lung carcinoma (SCLC) in which only the fluorodeoxyglucose-positron emission tomography (FDG-PET) positive lymph nodes were irradiated. In this trial, only 3% of isolated nodal failures were observed. However, all patients in that study were treated with 3D conformal radiotherapy (3DCRT). At present, IMRT techniques have become more standard in lung cancer. Because of the lower radiation dose to the lymph nodes outside of the planning target volume (PTV) with IMRT, higher incidences of isolated nodal failures may occur. In this trial, the investigators will investigate the patterns of local relapse after IMRT with concurrent chemotherapy in patients with stage I-III SCLC.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Concurrent Chemo-radiotherapy With IMRT for Stage I-III Small Cell Lung Cancer|
- Isolated nodal failures [ Time Frame: 18 months ] [ Designated as safety issue: No ]Proportion of isolated nodal failures 18 months post-radiotherapy
- Progression-free survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Dyspnea (CTCAE 4.0) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Dysphagia (CTCAE 4.0) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
|Study Start Date:||May 2009|
|Estimated Study Completion Date:||May 2015|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
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 45Gy in 30 fractions in 3 weeks (1.5Gy BID). Radiotherapy will be delivered concurrently with cisplatin (or in case of a creatinin clearance of <60ml/min, carboplatin) and etoposide chemotherapy. When after 4 cycles of chemotherapy and concurrent chest radiotherapy, no disease progression is observed and the WHO performance status is 0-2, PCI (prophylactic cranial irradiation) will bee offered to a dose of 25 Gy in 10 daily fractions.
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.
|Contact: Dirk De Ruysscher, MD, PhD||+31 88 44 55 firstname.lastname@example.org|
|Contact: Chantal Overhof||+31 88 44 55 email@example.com|
|Maastricht, Limburg, Netherlands, 6229 ET|
|Contact: Dirk De Ruysscher, MD, PhD +31 88 4455700 firstname.lastname@example.org|
|Contact: Chantal Overhof +31 88 44 55 686 email@example.com|
|Principal Investigator: Dirk De Ruysscher, MD,PhD|
|Principal Investigator:||Dirk De Ruysscher, MD, PhD||MAASTRO Clinic|