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

Tracking Information

• First Submitted Date: September 13, 2005
• First Posted Date: September 15, 2005
• Last Update Posted Date: April 22, 2008
• Study Start Date: October 1995
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: September 13, 2005): Progression free survival
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: September 13, 2005): Overall survival
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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 Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Non-Small Cell Lung Cancer
• Intervention: Procedure: preoperative radiochemotherapy
• Study Arms: Not Provided

Publications *

• 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.

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: September 13, 2005): 500
• Original Enrollment: Same as current
• Study Completion Date: September 2005
• Primary Completion Date: Not Provided

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 69 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: Germany

Administrative Information

• NCT Number: NCT00176137
• Other Study ID Numbers: GLCCG01/95; German Cancer Aid
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: Heidelberg University
• Original Study Sponsor: Same as current

Collaborators

• 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

• PRS Account: Heidelberg University
• Verification Date: April 2008