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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.
Study NCT00176137   Information provided by University of Heidelberg
First Received: September 13, 2005   Last Updated: April 21, 2008   History of Changes

September 13, 2005
April 21, 2008
October 1995
 
Progression free survival
Same as current
Complete list of historical versions of study NCT00176137 on ClinicalTrials.gov Archive Site
Overall survival
Same as current
 
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)

Phase III
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Non-Small Cell Lung Cancer
Procedure: preoperative radiochemotherapy
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
500
September 2005
 

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
 
 
NCT00176137
 
GLCCG01/95, German Cancer Aid
University of Heidelberg
  • Universitätsklinkum Münster
  • Lung Clinic Hemer
  • Kreiskrankenhaus Diekholzen
  • Universitätsklinikum des Saarlandes
  • FLT Berlin / Buch
Study Chair: Michael Thomas, Prof. / MD Current affiliation: Thoraxklinik am Universitätsklinikum Heidelberg
University of Heidelberg
April 2008

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