Concurrent Chemo-radiotherapy With Intensity-Modulated Radiation Therapy (IMRT) for Limited Disease Small Cell Lung Cancer (LD-SCLC)
Conditions
Stage I-III Small Cell Lung Cancer
Conditions: official terms
Lung Neoplasms - Small Cell Lung Carcinoma
Conditions: Keywords
Radiotherapy, SCLC
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Radiotherapy
Type: Radiation
Overall Status
Recruiting
Summary
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.
Detailed Description
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Histological of cytological proven SCLC

- UICC stage I-III, which are amendable for radical local treatment

- Performance status 0-2

- IMRT technique

Exclusion Criteria:

- Not SCLC or mixed SCLC and other histologies (e.g. non-small cell carcinoma)

- Stage IV

- Performance status 3 or more

- No IMRT technique
Location
MAASTRO clinic
Maastricht, Limburg, Netherlands
Status: Recruiting
Contact: Dirk De Ruysscher, MD, PhD - +31 88 4455700 - dirk.deruysscher@maastro.nl
Start Date
May 2009
Completion Date
May 2015
Sponsors
Maastricht Radiation Oncology
Source
Maastricht Radiation Oncology
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page