CTRI/2007/091/000037已完成2 期
Open label, randomized multicentric clinical trial of Mycobacterium w in combination with Paclitaxel plus Cisplatin versus paclitxel and cisplatin in advanced Non Small Cell Lung Cancer.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 221
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.INFORMED CONSENT OBTAINED & SIGNED:
- •o Ability to understand and the willingness to sign a written informed consent document.
- •2.DISEASE CHARACTERISTICS:
- •o Histologically or cytologically confirmed Non-Small Cell Lung Cancer, Stage IIIB or IV
- •3.PATIENT CHARACTERISTICS:
- •-18 completed years and above
- •o Performance status
- •-ECOG 0-1
- •o Life expectancy
- •-At least 24 weeks
- •o Hematopoietic
- •-Absolute neutrophil count >= 1,500/mm3
- •-Platelet count >= 1,00,000/mm3
- •-Hemoglobin >= 9.0 g/dL
- •-AST and ALT <= 2.5 times upper limit of normal (ULN) range of institution (5 times ULN if liver metastasis present).
- •-Bilirubin not greater than 1.5 times ULN range of institution (3 times ULN if liver involvement).
- •- Serum Creatinine less than 1.5 times upper limit of normal (ULN) range of Institutional Lab Range.
- •4. Negative Pregnancy test for women of child bearing potential prior to entry into the trial.
排除标准
- •1. Patients who have had cytotoxic chemotherapy or radiotherapy prior to entering the study.
- •2. Patients with symptomatic brain metastasis
- •3. History of allergic reactions attributed to paclitaxel, cisplatin or mycobacteria or any of their ingredients.
- •4. Pregnant women or nursing women
- •5. Uncontrolled intercurrent illness that would limit compliance with study requirements.
- •6. HIV positive patients
- •7. Previous splenectomy
研究者
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