Clinical trial NCT00572923: Concurrent Chemo-Radiotherapy for Limited Disease Small Cell Lung Cancer (LD-SCLC) on Basis of FDG-PET-Scans
Official title: Concurrent Chemo-Radiotherapy for Limited Disease Small Cell Lung Cancer (LD-SCLC) on Basis of FDG-PET-Scans
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Small Cell Lung Cancer
Keywords: radiotherapy
LD-SCLC
stage I-III small cell lung cancer
Lead sponsor: Maastricht Radiation Oncology
Sponsor class: OTHER
First posted: 2007-12-13
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * 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

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)

Eligibility criteria: 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

Primary outcomes:
measure: isolated Nodal Recurrences
timeFrame: 18 months post-treatment
Secondary outcomes:
measure: overall survival
timeFrame: 18 months post-treatment
measure: progression-free interval
timeFrame: 18 months post-treatment
measure: dyspnea (CTCAE 3.0)
timeFrame: 18 months post-treatment
measure: dysphagia (CTCAE 3.0)
timeFrame: 18 months post-treatment
measure: patterns of recurrence
timeFrame: 18 months post-treatment
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: MAASTRO clinic, Maastricht Radiation Oncology
Study officials:
affiliation: MAASTRO clinic, Maastricht Radiation Oncology
name: Dirk De Ruysscher, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: