A Phase II Trial of Erlotinib Versus Combination of Vinorelbine Plus Cisplatin as Adjuvant Treatment in Stage IIIA Non-small-cell Lung Cancer After Complete Resection With Sensitizing EGFR Mutation in Exon 19 or 21 and Wild-type K-ras
Sponsor study identifier
interventional
80
1 country
11
Study Start
May 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The purpose of this study is to assess the effect and safety of erlotinib versus NVB plus cisplatin (NP) as adjuvant treatment in patients with stage IIIA NSCLC after complete resection with EGFR activating mutations and to explore a new treatment strategy for this subset.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2011
Date type not reportedThis date has not been verified as actual or estimated.
August 1, 2011
Actual (reported)August 5, 2011
Actual (reported)July 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Disease-free survival
To evaluate Disease-free survival(DFS) of two groups
2 years
Number of Participants with Adverse Events
2 years
Quality of Life (QOL)
2 years
overall survival (OS)
2 years
In the adjuvant treatment phase, erlotinib 150 mg/day taken orally for 2 years or till disease progression or unacceptable toxicity.
In the adjuvant treatment phase, patient will receive vinorelbine 25mg/m2 IV on day 1 and day 8, and cisplatin 25mg/m2 on day 1 and day 2 and day 3, of a 3-week schedule for 4 cycles or till disease progression or unacceptable toxicity.
In the adjuvant treatment phase, erlotinib 150 mg/day taken orally for 2 years or till disease progression or unacceptable toxicity.
In the adjuvant treatment phase, patient will receive vinorelbine 25mg/m2 IV on day 1 and day 8, and cisplatin 25mg/m2 on day 1 and day 2 and day 3, of a 3-week schedule for 4 cycles or till disease progression or unacceptable toxicity.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
vinorelbine/cisplatin
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordBeijing Cancer Hospital
Beijing, Beijing Municipality, 100000, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100000, China
Sun Yat-Sen University Cancer Center
Changli Wang
Tianjin Medical University Cancer Institute and Hospital
First Submitted
August 1, 2011
First Posted
August 5, 2011
Study Start
May 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2015
Estimated (date passed)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Guangzhou, Guangdong, 510000, China
Hebei Medical University Fourth Hospital
Shijiazhuang, Hebei, 050000, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000, China
The First Affiurted Hospital of Soochow University
Suzhou, Jiangsu, 215000, China
Qingdao University Medical College
Qingdao, Shandong, 266000, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000, China
The Second People's Hospital of Sichuan
Chengdu, Sichuang, 610000, China
Tianjin Medical University Cancer Institute and Hospital
Tianji, Tianji, 300000, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310000, China
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 23, 2011
Record last verified: 2011-12
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Source: ClinicalTrials.gov.
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