Chemoradiotherapy in Stage III Non-small Cell Lung Cancer (NSCLC)
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|ClinicalTrials.gov Identifier: NCT01102231|
Recruitment Status : Completed
First Posted : April 13, 2010
Results First Posted : February 16, 2021
Last Update Posted : February 16, 2021
|Condition or disease||Intervention/treatment||Phase|
|Stage III Non-small Cell Lung Cancer||Drug: Chemotherapy Drug: ERBITUX Radiation: Radiotherapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||106 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Pemetrexed + Cetuximab + Cisplatin With Concurrent Chemoradiotherapy in Stage III Non-small Cell Lung Cancer (NSCLC)|
|Actual Study Start Date :||March 2010|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||December 2015|
Pemetrexed 500 mg/m², D1 (D1=D22, 4 cycles) Cisplatin 75 mg/m², D1 (D1=D22, 4 cycles)
The initial dose of cetuximab (ERBITUX) is 400 mg/m² intravenously administered over 120 minutes, followed by 11 weekly infusions at 250 mg/m² IV over 60 minutes
66 Gy (2 Gy by fraction, 5 fractions by week)
- Disease-Control Rate [ Time Frame: 16 weeks after inclusion ]
percentage of patients with disease control (complete response + partial response + stable disease) according to RECIST 1.1 criteria Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions.
Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for Progressive Disease (at least a 20% increase in the sum of diameters of target lesions).
- 18-month Overall Survival Rate [ Time Frame: 18 months ]Percentage of patient alive 18 months after registration
- Progression Free Survival [ Time Frame: 52.3 months (median duration of follow-up) ]
Progression-free survival is defined as time between date of inclusion and progression or all-cause death.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01102231
|Principal Investigator:||Jean Trédaniel, MD, PhD||IFCT, GH Paris Saint-Joseph|
|Principal Investigator:||Françoise Mornex, MD, PhD||IFCT, HCL Lyon-Sud|