Cetuximab Plus Conformal Thoracic Radiotherapy in Patients (Pts) With Inoperable or Unresectable Locally Advanced Non-Small Cell Lung Cancer (LA - NSCLC)
|ClinicalTrials.gov Identifier: NCT00673738|
Recruitment Status : Completed
First Posted : May 7, 2008
Results First Posted : March 4, 2014
Last Update Posted : October 8, 2015
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: Cetuximab Radiation: Conformal Thoracic Radiotherapy (CTRT)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy (Phase II) Study of Concurrent Cetuximab Plus Conformal Thoracic Radiotherapy in (Poor Prognosis) Patients With Inoperable or Unresectable, Locally Advanced Non-Small Cell Lung Cancer (LA - NSCLC)|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||August 2015|
Experimental: Cetuximab Plus Radiotherapy
Concurrent Cetuximab plus Conformal Thoracic Radiotherapy (CTRT). Patients were treated with definitive radiotherapy (70 Gy in 35 fractions, per our currently-existing institutional standard) with concurrent cetuximab followed by 3 cycles of consolidation docetaxel plus cetuximab.
Radiation: Conformal Thoracic Radiotherapy (CTRT)
- Median Progression Free Survival (PFS) [ Time Frame: Up to 36 months ]Progression Free Survival is defined as the interval between the date of the first cetuximab administration and the date of objective progression of disease. Progression was evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
- Median Overall Survival (OS) [ Time Frame: Up to 36 months ]Overall survival is defined as the time from randomization until death from any cause.
- Overall Response Rate (ORR) [ Time Frame: Up to 36 months ]ORR = Complete Response (CR) + Partial Response (CR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete Response: Disappearance of all target lesions; Partial Response: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00673738
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Alberto Chiappori, M.D.||H. Lee Moffitt Cancer Center and Research Institute|