Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT01500720
Brief Summary:
Primary Objective:
To demonstrate progression free survival (PFS) improvement for cabazitaxel compared to topotecan in participants with sensitive or resistant/refractory small cell lung cancer following a first line platinum based chemotherapy.
Secondary Objectives:
* To assess disease progression free rate at 12 weeks
* To assess Response Rate (Response Evaluation Criteria in Solid Tumor \[RECIST\] 1.1) and duration of response
* To assess Overall Survival (OS)
* To assess the Safety (National Cancer Institute - Common Toxicity Criteria \[NCI-CTC\] version 4.03)
* To assess the Health-Related Quality of Life (HRQoL)
Detailed Description:
Participants are to be treated until progressive disease, unacceptable toxicity or refusal for further study treatment.
All participants are to be followed for disease progression documentation and for participant status until the study cut-off date.
Study:
NCT01500720
Study Brief:
Protocol Section:
NCT01500720