ISRCTN16174527已完成3 期
A phase III randomised, double blind, placebo controlled trial of carboplatin/etoposide with or without thalidomide in small cell lung cancer
Sponsor not defined - Record supplied by London Lung Cancer Group0 个研究点目标入组 724 人开始时间: 2003年7月2日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 724
研究概览
简要总结
2009 Results article in http://www.ncbi.nlm.nih.gov/sites/pubmed/19608997 results
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Histologically or cytologically confirmed small cell lung cancer
- •2. Limited or extensive stage disease
- •3. Have had no prior chemotherapy or radiotherapy
- •4. Have no symptomatic brain metastases thought to require immediate radiotherapy
- •5. No evidence of significant medical condition or laboratory finding which, in the opinion of the investigator, makes it undesirable for the patient to participate in the trial
- •6. Either sex, age over 18
- •7. Eastern Cooperative Oncology Group (ECOG) performance status zero to three
- •8. Estimated life expectancy of at least eight weeks
- •9. Renal function adequate for chemotherapy i.e. Ethylene Diamine Tetraacetic Acid (EDTA) clearance greater than 60 ml/min
- •10. Women of Child-Bearing Potential (WCBP) MUST have a negative serum or urine pregnancy test (minimal sensitivity 50 mIU/mL) performed by healthcare professional within 24 hours before starting study medication
- •11. WCBP must agree to practice complete abstinence from heterosexual intercourse or to use two methods of contraception (must include one highly effective barrier method [i.e. intrauterine device, hormonal birth control pills, injections or implants, tubal litigation, partner?s vasectomy) and one additional effective barrier method (i.e. latex or polyurethane condom, diaphragm, cervical cap) while on study medication and for four weeks after the last dose of study medication
- •12. WCBP who are sexually active in a heterosexual relationship must agree to have pregnancy tests every four weeks while on study medication and four weeks after the last dose of study medication
- •13. Male patients (including those who have had a vasectomy) must use barrier contraception (latex or polyurethane condoms) when engaging in heterosexual activity with WCBP while on study medication and four weeks after the last dose of study medication
- •14. Pregnant or lactating women or WCBP not using adequate contraception are excluded.
- •15. All WCBP who have had unprotected sexual intercourse within two weeks prior to study entry should not start study until the beginning of her next period or a negative pregnancy test
- •16. No history of prior malignant tumour, unless patient has been without evidence of disease for at least three years or the tumour was a non-melanoma tumour or early cervical cancer
排除标准
- •1. Pregnant or lactating women or WCBP not using adequate contraception
- •2. Prior treatment with chemotherapy or radiotherapy
- •3. Evidence of significant medical condition or laboratory finding which, in the opinion of the investigator, makes it undesirable for the patient to participate in the trial
- •4. Prior history of thromboembolic event (including: Pulmonary Embolism [PE], Deep Vein Thrombus [DVT], Cerebro-Vascular Accident [CVA] / Transient Ischaemic Attack [TIA])
- •5. Symptomatic brain metastases thought to require immediate radiotherapy
- •6. History of prior malignant tumour, unless the patient has been without evidence of disease for at least three years or the tumour was a non-melanoma skin tumour or early cervical cancer
研究者
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