drugset / Trial / NCT00390806

Oral HYCAMTIN Plus Whole Brain Radiation Therapy In Treatment Of Brain Metastases Resulting From Non-Small Lung Cancer

NCT00390806 ↗

Phase 3 Completed 472 enrolled GlaxoSmithKline
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2006-12
Primary completion
2012-07
Completion
2013-09

Outcome

Missed primary endpoint

registry Chemoradiation: Topotecan Plus WBRT vs Radiation: WBRT Alone; p = 0.1862; Hazard Ratio (HR) 0.88 (95% CI 0.73 to 1.07); Log Rank NCT00390806 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Topotecan Small molecule 1.1 mg/m2 Oral