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

Sponsor
Heidelberg University (Other)
Overall Status
Completed
CT.gov ID
NCT00176137
Collaborator
University Hospital Muenster (Other), Lung Clinic Hemer (Other), Kreiskrankenhaus Diekholzen (Other), University Hospital, Saarland (Other), FLT Berlin / Buch (Other)
500
Enrollment
119
Duration (Months)

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Procedure: preoperative radiochemotherapy
 Phase 3

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)

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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)
Study Start Date :
Oct 1, 1995
Study Completion Date :
Sep 1, 2005

Outcome Measures

Primary Outcome Measures

  1. Progression free survival []

Secondary Outcome Measures

  1. Overall survival []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 69 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

No locations specified.

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00176137
Other Study ID Numbers:
  • GLCCG01/95
  • German Cancer Aid
First Posted:
Sep 15, 2005
Last Update Posted:
Apr 22, 2008
Last Verified:
Apr 1, 2008
Keywords provided by , ,
multimodality treatment
Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Apr 22, 2008