Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT00388960
Eligibility Criteria:
Inclusion Criteria:
* Histologically/cytologically proven small cell lung cancer
* Extensive disease
* Measurable disease
* World Health Organization (WHO) performance status 0-2
* Age 18 years or older
* Normal baseline cardiac function
* No prior systemic chemotherapy for small cell lung cancer
* Adequate organ function including bone marrow, kidney, and liver
* No history of interstitial lung disease or pulmonary fibrosis
* No history of prior malignancy unless patient has been disease free for greater than 5 years, or the tumour was a non-melanoma skin cancer or in-situ carcinoma of the cervix
* No pregnancy or breast feeding; patients of child-bearing potential must agree to use an appropriate method of contraception
* Written informed consent before randomization
Exclusion criteria:
* Pre-existing peripheral neuropathy (greater than Grade 1, CTCAE version 3.0)
* Uncontrolled or severe cardiovascular disease
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00388960
Study Brief:
Protocol Section:
NCT00388960