NCT00390806

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 472 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Cancer, Non-Small Cell

Interventions

Type	Name	Description
DRUG	HYCAMTIN, oral capsules	topotecan oral capsules 1.1 mg/m2
RADIATION	Radiation	Whole brain radiation

Timeline

• Start date: 2006-12-01
• Primary completion: 2012-07-01
• Completion: 2013-09-01
• First posted: 2006-10-20
• Last updated: 2014-01-20
• Results posted: 2014-01-20

Locations

88 sites across 6 countries: United States, Canada, Hungary, Poland, Russia, Slovakia