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

简要总结

主要结局

次要结局

• Six-month Survival(Month 6)
• Number of Participants With a Complete Response (CR) or a Partial Response (PR) (Central Nervous System [CNS]-Radiologic)(From the time of Randomization until the time of CR or PR (up to 75 weeks))
• Time to Response (TTR) (CNS-radiologic)(From the time of Randomization until the first documented evidence of CR or PR (up to 75 weeks))
• Time to Progression (TTP) (CNS-radiologic)(From the time of Randomization until the first documented sign of disease progression (up to 75 weeks))
• Time to Progression (TTP) (All Sites of Disease-radiologic)(From the time of Randomization until the first documented sign of disease progression (up to 75 weeks))
• Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3(Months 1 and 3)
• Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Level of Consciousness at Baseline, Month 1, and Month 3(Baseline, Month 1, and Month 3)
• Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Headache at Baseline, Month 1, and Month 3(Baseline, Month 1, and Month 3)
• Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Dizziness/Lightheadedness at Baseline, Month 1, and Month 3(Baseline, Month 1, and Month 3)
• Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Vertigo at Baseline, Month 1, and Month 3(Baseline, Month 1, and Month 3)
• Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Nausea/Vomiting at Baseline, Month 1, and Month 3(Baseline, Month 1, and Month 3)
• Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Visual Problem at Baseline, Month 1, and Month 3(Baseline, Month 1, and Month 3)
• Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Seizure at Baseline, Month 1, and Month 3(Baseline, Month 1, and Month 3)
• Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Other Neurological Symptoms at Baseline, Month 1, and Month 3(Baseline, Month 1, and Month 3)
• Number of Participants With the Indicated Investigator Assessment of Cranial Nerves II-XII at Baseline, Month 1, and Month 3(Baseline, Month 1, and Month 3)
• Number of Participants With the Indicated Investigator Assessment of Language (Dysphasia or Aphasia) at Baseline, Month 1, and Month 3(Baseline, Month 1, and Month 3)
• Number of Participants With the Indicated Investigator Assessment of Strength (Right Upper Extremity) at Baseline, Month 1, and Month 3(Baseline, Month 1, and Month 3)
• Number of Participants With the Indicated Investigator Assessment of Strength (Left Upper Extremity) at Baseline, Month 1, and Month 3(Baseline, Month 1, and Month 3)
• Number of Participants With the Indicated Investigator Assessment of Strength (Right Lower Extremity) at Baseline, Month 1, and Month 3(Baseline, Month 1, and Month 3)
• Number of Participants With the Indicated Investigator Assessment of Strength (Left Lower Extremity) at Baseline, Month 1, and Month 3(Baseline, Month 1, and Month 3)
• Number of Participants With the Indicated Investigator Assessment of Sensation at Baseline, Month 1, and Month 3(Baseline, Month 1, and Month 3)
• Number of Participants With the Indicated Investigator Assessment of Ataxia (Right Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3(Baseline, Month 1, and Month 3)
• Number of Participants With the Indicated Investigator Assessment of Ataxia (Left Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3(Baseline, Month 1, and Month 3)
• Number of Participants With the Indicated Investigator Assessment of Ataxia (Gait) at Baseline, Month 1, and Month 3(Baseline, Month 1, and Month 3)
• Number of Participants With the Indicated Investigator Assessment of Ataxia (Balance) at Baseline, Month 1, and Month 3(Baseline, Month 1, and Month 3)
• Number of Participants With Any Adverse Event (AE; Both Serious and Non-serious) or Serious Adverse Event (SAE)(From Randomization until the last clinic visit associated with the study, up until 35 days after the start of the last course of treatment (up to 75 weeks))
• Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range(From Randomization until the last clinic visit associated with the study, up until 35 days after the start of the last course of treatment (up to 75 weeks))
• Lesion Assessment and Measurement(From the time of Randomization until the time of CR or PR (up to 75 weeks))
• Brain Symptoms(Baseline, Month 1, and Month 3)
• Number of Participants Who Died or Progressed(From Randomization until the last clinic visit associated with the study, up until 35 days after the start of the last course of treatment (up to 75 weeks))