Concurrent Chemo-Radiotherapy for Limited Disease Small Cell Lung Cancer (LD-SCLC) on Basis of FDG-PET-Scans

Completed

• Conditions: Small Cell Lung Cancer

• Registration Number: NCT00572923
• Lead Sponsor: Maastricht Radiation Oncology

Brief Summary

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.

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 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 Timeline

• Study Start: 2006-08
• Study First Submitted: 2007-12-12
• Study First Submitted QC: 2007-12-12
• Study First Posted: 2007-12-13
• Study Completion: 2009-02
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-16
• Last Update Posted: 2009-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Histological or cytological proven SCLC
• UICC stage I-III, "limited disease"
• Performance status 0-2
• FeV 1 and DLCO at least 30% of the age-predicted value

Exclusion Criteria

• Not SCLC or mixed SCLC and other histologies (e.g. non-small cell lung carcinoma)
• UICC stage IV
• Performance status 3 or more
• FeV 1 and DLCO < 30% of the age-predicted value

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
isolated Nodal Recurrences	18 months post-treatment

Secondary Outcome Measures

Name	Time	Method
overall survival	18 months post-treatment
progression-free interval	18 months post-treatment
dyspnea (CTCAE 3.0)	18 months post-treatment
dysphagia (CTCAE 3.0)	18 months post-treatment
patterns of recurrence	18 months post-treatment

Trial Locations

Locations (1)

MAASTRO clinic, Maastricht Radiation Oncology; 🇳🇱 Maastricht, Netherlands