Concurrent Chemo-Radiotherapy for Limited Disease Small Cell Lung Cancer (LD-SCLC) on Basis of FDG-PET-Scans (BRONC 45 15)

This study has been completed.
Sponsor:
Information provided by:
Maastricht Radiation Oncology
ClinicalTrials.gov Identifier:
NCT00572923
First received: December 12, 2007
Last updated: June 16, 2009
Last verified: June 2009

December 12, 2007
June 16, 2009
August 2006
Not Provided
isolated Nodal Recurrences [ Time Frame: 18 months post-treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00572923 on ClinicalTrials.gov Archive Site
  • overall survival [ Time Frame: 18 months post-treatment ] [ Designated as safety issue: No ]
  • progression-free interval [ Time Frame: 18 months post-treatment ] [ Designated as safety issue: No ]
  • dyspnea (CTCAE 3.0) [ Time Frame: 18 months post-treatment ] [ Designated as safety issue: No ]
  • dysphagia (CTCAE 3.0) [ Time Frame: 18 months post-treatment ] [ Designated as safety issue: No ]
  • patterns of recurrence [ Time Frame: 18 months post-treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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):

  • 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)

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
  • 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
Small Cell Lung Cancer
Not Provided
1

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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
February 2009
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00572923
BRONC 45, 1.5
No
MAASTRO clinic
Maastricht Radiation Oncology
Not Provided
Principal Investigator: Dirk De Ruysscher, MD,PhD MAASTRO clinic, Maastricht Radiation Oncology
Maastricht Radiation Oncology
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP