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

• ClinicalTrials.gov Identifier: NCT00176137
• Recruitment Status: Completed
• First Posted: September 15, 2005
• Last Update Posted: April 22, 2008
• Sponsor: Heidelberg University
• Collaborators: University Hospital Muenster; Lung Clinic Hemer; Kreiskrankenhaus Diekholzen; University Hospital, Saarland; FLT Berlin / Buch
• Information provided by: Heidelberg University

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
Non-Small Cell Lung Cancer	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 (Clinical Trial)
• Enrollment: 500 participants
• 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: October 1995
• Study Completion Date: September 2005

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. Progression free survival

Secondary Outcome Measures :

1. Overall survival

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 69 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. doi: 10.1183/09031936.00121108. Epub 2009 Feb 12.

Thomas M, Rube C, Hoffknecht P, Macha HN, Freitag L, Linder A, Willich N, Hamm M, Sybrecht GW, Ukena D, Deppermann KM, Droge 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. doi: 10.1016/S1470-2045(08)70156-6. Epub 2008 Jun 24.

• ClinicalTrials.gov Identifier: NCT00176137
• Other Study ID Numbers: GLCCG01/95; German Cancer Aid
• First Posted: September 15, 2005
• Last Update Posted: April 22, 2008
• Last Verified: April 2008

Keywords provided by Heidelberg University:

multimodality treatment

Additional relevant MeSH terms:

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