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.

First Received: September 13, 2005 Last Updated: April 21, 2008 History of Changes

Sponsor:	University of Heidelberg
Collaborators:	Universitätsklinkum Münster Lung Clinic Hemer Kreiskrankenhaus Diekholzen Universitätsklinikum des Saarlandes FLT Berlin / Buch
Information provided by:	University of Heidelberg
ClinicalTrials.gov Identifier:	NCT00176137

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Cancer Lung Cancer Surgery

U.S. FDA Resources

Further study details as provided by University of Heidelberg:

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

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

Sponsors and Collaborators

University of Heidelberg

Universitätsklinkum Münster

Lung Clinic Hemer

Kreiskrankenhaus Diekholzen

Universitätsklinikum des Saarlandes

FLT Berlin / Buch

Investigators

Study Chair:

Michael Thomas, Prof. / MD

Current affiliation: Thoraxklinik am Universitätsklinikum Heidelberg

More Information

No publications provided by University of Heidelberg

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Kreuter M, Kropff M, Fischaleck A, Junker K, Gerss J, Heinecke A, Lindermann M, Reinmuth N, Berdel WE, Mesters RM, Thomas M. Prognostic relevance of angiogenesis in stage III NSCLC receiving multimodality treatment. Eur Respir J. 2009 Jun;33(6):1383-8. Epub 2009 Feb 12.

Thomas M, Rübe C, Hoffknecht P, Macha HN, Freitag L, Linder A, Willich N, Hamm M, Sybrecht GW, Ukena D, Deppermann KM, Dröge C, Riesenbeck D, Heinecke A, Sauerland C, Junker K, Berdel WE, Semik M; German Lung Cancer Cooperative Group. Effect of preoperative chemoradiation in addition to preoperative chemotherapy: a randomised trial in stage III non-small-cell lung cancer. Lancet Oncol. 2008 Jul;9(7):636-48. Epub 2008 Jun 24.

Study ID Numbers:	GLCCG01/95, German Cancer Aid
Study First Received:	September 13, 2005
Last Updated:	April 21, 2008
ClinicalTrials.gov Identifier:	NCT00176137 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Heidelberg:

multimodality treatment

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Respiratory Tract Diseases

Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on November 27, 2009