Preoperative Twice Daily Chemoradiation in Addition to Chemotherapy Prior to Surgery in Stage III Non-Small Cell Lung Cancer (NSCLC)
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)
2 other identifiers
interventional
500
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 nonsmall-cell-lung-cancer
Started Oct 1995
Longer than P75 for phase_3 nonsmall-cell-lung-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 1995
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedApril 22, 2008
April 1, 2008
September 13, 2005
April 21, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression free survival
Secondary Outcomes (1)
Overall survival
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- small cell lung cancer
- cardiac disability (NYHA III/IV)
- prior radio- or chemotherapy
- pregnancy
- other malignancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Heidelberg Universitylead
- University Hospital Muenstercollaborator
- Lung Clinic Hemercollaborator
- Kreiskrankenhaus Diekholzencollaborator
- University Hospital, Saarlandcollaborator
- FLT Berlin / Buchcollaborator
Related Publications (2)
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.
PMID: 19213790DERIVEDThomas 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.
PMID: 18583190DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Michael Thomas, Prof. / MD
Current affiliation: Thoraxklinik am Universitätsklinikum Heidelberg
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 15, 2005
Study Start
October 1, 1995
Study Completion
September 1, 2005
Last Updated
April 22, 2008
Record last verified: 2008-04