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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00572923
Acronym
BRONC 45 15
Enrollment
52
Registered
2007-12-13
Start date
2006-08-31
Completion date
2009-02-28
Last updated
2009-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small Cell Lung Cancer

Keywords

radiotherapy, LD-SCLC, stage I-III small cell lung cancer

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)

Interventions

None listed

Sponsors

Maastricht Radiation Oncology
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
isolated Nodal Recurrences18 months post-treatment

Secondary

MeasureTime frame
overall survival18 months post-treatment
progression-free interval18 months post-treatment
dyspnea (CTCAE 3.0)18 months post-treatment
dysphagia (CTCAE 3.0)18 months post-treatment
patterns of recurrence18 months post-treatment

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026