At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 472 enrolled
Drug / intervention
HYCAMTIN, oral capsules +1 moredrug
Likely dose
HYCAMTIN, oral capsules 1.1 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Phase III, Open-Label Study of Oral Topotecan Plus Whole-Brain Radiation Therapy (WBRT) Compared With WBRT Alone in Patients With Brain Metastases From Non-Small Cell Lung Cancer
In Brief
A Phase 3 clinical trial evaluating HYCAMTIN, oral capsules and Radiation for Lung Cancer, Non-Small Cell. Completed, enrolled 472 participants across 88 sites in 6 countries.
Detailed Summary
The current prognosis for patients with metastatic brain cancer from NSCLC is very poor. The current standard treatment for this disease is radiation therapy to the brain. The goal of the current study is to test whether the combination of orally administered HYCAMTIN capsules and whole brain radiation therapy will prolong the survival time of patients with this potentially serious condition.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer, Non-Small Cell
CountriesCanada, Hungary, Poland, Russia, Slovakia, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 2006
Enrollment StartDec 2006
Primary CompletionJul 2012
Study CompletionSep 2013
TodayJul 2026
First PostedOct 20, 2006
Enrollment StartDec 1, 2006
Primary CompletionJul 1, 2012
Study CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 19.7 years ago
Interventions
HYCAMTIN, oral capsulesdrug
topotecan oral capsules 1.1 mg/m2
Radiationradiation
Whole brain radiation