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

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

April 21, 2008

Start Date ^ICMJE

October 1995

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Progression free survival

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00176137 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Overall survival

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

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.

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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Non-Small Cell Lung Cancer

Intervention ^ICMJE

Procedure: preoperative radiochemotherapy

Study Arms / Comparison Groups

Publications *

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

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

500

Completion Date

September 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 69 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00176137

Responsible Party

Study ID Numbers ^ICMJE

GLCCG01/95, German Cancer Aid

Study Sponsor ^ICMJE

University of Heidelberg

Collaborators ^ICMJE

Universitätsklinkum Münster
Lung Clinic Hemer
Kreiskrankenhaus Diekholzen
Universitätsklinikum des Saarlandes
FLT Berlin / Buch

Investigators ^ICMJE

Study Chair:

Michael Thomas, Prof. / MD

Current affiliation: Thoraxklinik am Universitätsklinikum Heidelberg

Information Provided By

University of Heidelberg

Verification Date

April 2008

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