Conditions: Lung Cancer, Non-Small Cell
Keywords: Brain metastases from Non-Small Cell Lung Cancer Brain metastases brain tumor lung cancer oral chemotherapy HYCAMTIN topotecan NSCLC WBRT whole brain radiation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 472
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: topotecan 1.1 mg/m2 followed by whole brain radiation 3 Gy/day for 10 days, followed by optional continuation therapy with topotecan 2.3 mg/m2 for 5 days Q21 days as monotherapy. arm 2: Whole brain radiation 3 Gy/day for 10 days

Interventions: intervention 1: HYCAMTIN, oral capsules intervention 2: Radiation
Intervention descriptions: intervention 1: topotecan oral capsules 1.1 mg/m2 intervention 2: Whole brain radiation

Protocol document: