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Completed

NCT Number: NCT00176137

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

preoperative radiochemotherapy

Procedure

Primary outcomes

  1. Progression free survival

Secondary outcomes

  1. Overall survival

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Collaborators

  • FLT Berlin / Buch
  • Kreiskrankenhaus Diekholzen
  • Lung Clinic Hemer
  • University Hospital Muenster
  • University Hospital, Saarland

Registry information

Official study 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)

Important dates

Study start
1995
Study completion
2005
First posted
Sep 15, 2005
Registry last updated
Apr 22, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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