Preoperative Twice Daily Chemoradiation in Addition to Chemotherapy Prior to Surgery in Stage III Non-Small Cell Lung Cancer (NSCLC)

This study has been completed.
Sponsor:
Collaborators:
University Hospital Muenster
Lung Clinic Hemer
Kreiskrankenhaus Diekholzen
University Hospital, Saarland
FLT Berlin / Buch
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT00176137
First received: September 13, 2005
Last updated: April 21, 2008
Last verified: April 2008

September 13, 2005
April 21, 2008
October 1995
Not Provided
Progression free survival
Same as current
Complete list of historical versions of study NCT00176137 on ClinicalTrials.gov Archive Site
Overall survival
Same as current
Not Provided
Not Provided
 
Preoperative Twice Daily Chemoradiation in Addition to Chemotherapy Prior to Surgery in Stage III Non-Small Cell Lung Cancer (NSCLC)
Cisplatin/Etoposide Followed by Twice-Daily Chemoradiation (hfRT/CT) Versus Cisplatin/Etoposide Alone Before Surgery in Stage III Non-Small Cell Lung Cancer. A Phase III Trial of the German Lung Cancer Cooperative Group (GLCCG)

Patients are randomized to (arm A) 3 cycles of cisplatin/etoposide, followed by hyperfractionated radiotherapy (hfRT)with concurrent carboplatin and vindesine then surgery and, if no or R1/2-resection, additional hfRT versus (arm B) 3 cycles of cisplatin/etoposide, followed by surgery and then RT.

The primary endpoint was progression free survival (PFS). With 500 patients evaluable an improvement of median PFS from 10 to 14 months could be detected.

Patients are randomized to (arm A) 3 cycles of cisplatin 55 mg/m2 (d 1 + 4)/etoposide 100 mg/m2 (d 1-4), followed by hyperfractionated radiotherapy (hfRT; 45 Gy, 2x1.5 Gy/d) with concurrent carboplatin (100 mg/m2) and vindesine (3 mg) (d 1, 8, 15), then surgery and, if no or R1/2-resection, additional hfRT (24 Gy; 2x1.5 Gy/d) versus (arm B) 3 cycles of cisplatin 55 mg/m2 (d 1 + 4)/etoposide 100 mg/m2 (d 1-4),followed by surgery and then RT (1.8 Gy/d) with 54 Gy or, if no or R1/2-resection, 68.4 Gy.

The primary endpoint was progression free survival (PFS). With 500 patients evaluable an improvement of median PFS from 10 to 14 months could be detected.

(University of Münster was the lead sponsor; as the trial was implemented in clinicaltrials.gov by the principal investigator after he had moved to University of Heidelberg this account is announced above)

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
Procedure: preoperative radiochemotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
September 2005
Not Provided

Inclusion Criteria:

  • non-small cell lung cancer proven by histology
  • stage IIIA / stage IIIB
  • mediastinoscopy
  • performance score ECOG 0,1
  • predicted postoperative FEV 1 > 1.0 l

Exclusion Criteria:

  • small cell lung cancer
  • cardiac disability (NYHA III/IV)
  • prior radio- or chemotherapy
  • pregnancy
  • other malignancy
Both
18 Years to 69 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00176137
GLCCG01/95, German Cancer Aid
Not Provided
Not Provided
Heidelberg University
  • University Hospital Muenster
  • Lung Clinic Hemer
  • Kreiskrankenhaus Diekholzen
  • University Hospital, Saarland
  • FLT Berlin / Buch
Study Chair: Michael Thomas, Prof. / MD Current affiliation: Thoraxklinik am Universitätsklinikum Heidelberg
Heidelberg University
April 2008

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