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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
History of Changes
  Purpose

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.


Condition
Small Cell Lung Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Concurrent Chemo-Radiotherapy for Limited Disease Small Cell Lung Cancer (LD-SCLC) on Basis of FDG-PET-Scans

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Maastricht Radiation Oncology:

Primary Outcome Measures:
  • isolated Nodal Recurrences [ Time Frame: 18 months post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 52
Study Start Date: August 2006
Study Completion Date: February 2009
Groups/Cohorts
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00572923

Locations
Netherlands
MAASTRO clinic, Maastricht Radiation Oncology
Maastricht, Netherlands, 6202 AZ
Sponsors and Collaborators
Maastricht Radiation Oncology
Investigators
Principal Investigator: Dirk De Ruysscher, MD,PhD MAASTRO clinic, Maastricht Radiation Oncology
  More Information

No publications provided

Responsible Party: MAASTRO clinic
ClinicalTrials.gov Identifier: NCT00572923     History of Changes
Other Study ID Numbers: BRONC 45, 1.5
Study First Received: December 12, 2007
Last Updated: June 16, 2009
Health Authority: Netherlands:Board MAASTRO clinic

Keywords provided by Maastricht Radiation Oncology:
radiotherapy
LD-SCLC
stage I-III small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on May 16, 2013