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
  Purpose

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.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Procedure: preoperative radiochemotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • Progression free survival

Secondary Outcome Measures:
  • Overall survival

Estimated Enrollment: 500
Study Start Date: October 1995
Estimated Study Completion Date: September 2005
Detailed Description:

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)

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00176137

Sponsors and Collaborators
Heidelberg University
University Hospital Muenster
Lung Clinic Hemer
Kreiskrankenhaus Diekholzen
University Hospital, Saarland
FLT Berlin / Buch
Investigators
Study Chair: Michael Thomas, Prof. / MD Current affiliation: Thoraxklinik am Universitätsklinikum Heidelberg
  More Information

No publications provided by Heidelberg University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00176137     History of Changes
Other Study ID Numbers: GLCCG01/95, German Cancer Aid
Study First Received: September 13, 2005
Last Updated: April 21, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Heidelberg University:
multimodality treatment

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

ClinicalTrials.gov processed this record on October 21, 2014