An observational study in Small Cell Lung Cancer, sponsored by Maastricht Radiation Oncology. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-06-17.
Sponsored by Maastricht Radiation Oncology · Observational
Our group has shown that the omission of elective nodal irradiation on the basis of CT scans in patients with LD-SCLC lead to a higher than expected isolated nodal recurrence in the ipsilateral supraclavicular area. We have previously also shown that selective mediastinal nodal radiation on basis of FDG-PET scans in NSCLC is safe and reduces the radiation fields and hence toxicity. As the accuracy of FDG-PET scans is also in SCLC higher than CT, we will investigate the safety of selective nodal irradiation in LD-SCLC patients treated with concurrent chemo-radiation.
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):
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)
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 52 is below the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Maastricht Radiation Oncology is the lead sponsor of 104 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Inclusion criteria * Histological or cytological proven SCLC * UICC stage I-III, "limited disease" * Performance status 0-2 * FeV1 and DLCO at least 30% of age-predicted value Exclusion criteria: * Not SCLC or mixed SCLC and other histologies (e.g. non-small cell carcinoma) * stage IV * performance status 3 or more * FeV 1 or DLCO\< 30% of the age-predicted value
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
This study is completed, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.
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Maastricht Radiation Oncology