A Randomized Phase 2 Study of Maintenance Temozolomide Versus Observation in Stable or Responding Stage III/IV Non-Small Cell Lung Cancer Patients
Sponsor study identifier
interventional
53
0 countries
N/A
Study Start
March 4, 2008
Actual (reported)Primary Completion
January 6, 2011
Actual (reported)Study Completion
January 7, 2011
Actual (reported)The main objective of this study is to investigate whether administration of maintenance temozolomide following standard treatment could possibly prevent or delay the onset of brain metastases in patients with controlled non-small cell lung cancer (NSCLC).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 7, 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 29, 2008
Actual (reported)March 4, 2008
Actual (reported)March 10, 2008
Actual (reported)January 6, 2011
Actual (reported)January 7, 2011
Actual (reported)March 26, 2012
Actual (reported)Number of Participants Who Had Brain Metastases
Brain Metastases were defined as radiological evidence of brain metastases on magnetic resonance imaging (MRI).
Up to 12 months (as measured from day 1 of cycle 1 of standard first-line systemic chemotherapy)
Time to Radiological Central Nervous System (CNS) Progression
from Cycle 1 Day 1 of Standard First Line Systemic Therapy to radiological progression or the last known CNS progression-free date
Time to Progression
from Cycle 1 Day 1 of Standard First Line Systemic Therapy to progression or up to 6 cycles (168 days) of study treatment
Overall Survival
from Cycle 1 Day 1 of Standard First Line Systemic Therapy to the last time of follow-up
Number of Participants With Brain Metastases at First Progression
from Cycle 1 Day 1 of Standard First Line Systemic Therapy to the last time of follow-up (up to 6 cycles (168 days) of study treatment)
Cancer-related Quality of Life (QoL) as Assessed by The European Organization for Research and Treatment of Cancer (EORTC) QoL Questionnaire C30 Version 3.0 (QLQ-C30), and the EORTC Lung Cancer Module (QLQ-LC13)
from Cycle 1 Day 1 of Standard First Line Systemic Therapy to the last time of follow-up (up to 6 cycles (168 days) of study treatment)
Subjects will receive temozolomide at a dose of 75 mg/m\^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period, until progression or up to a maximum of 6 cycles, whichever occurs first.
Observation
5-mg, 20-mg, and 100-mg gel capsules, 75 mg/m\^2 PO daily for 21 consecutive days, followed by a 7-day rest period, until progression or up to a maximum of 6 cycles, whichever occurs first.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Boggs DH, Robins HI, Langer CJ, Traynor AM, Berkowitz MJ, Mehta MP. Strategies to prevent brain metastasis in high-risk non-small-cell lung cancer: lessons learned from a randomized study of maintenance temozolomide versus observation. Clin Lung Cancer. 2014 Nov;15(6):433-40. doi: 10.1016/j.cllc.2014.06.008. Epub 2014 Jun 24.
The interpretation of the study results should be taken with caution because of the small sample size due to early termination.
53 participants (actual enrollment reported by the registry).
First Submitted
February 29, 2008
First Posted
March 10, 2008
Study Start
March 4, 2008
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
January 6, 2011
Actual (reported)Study Completion
January 7, 2011
Actual (reported)Last Updated
June 7, 2017
Results First Posted
March 26, 2012
Record last verified: 2017-05
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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