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
- 试验地点
- 17
- 主要终点
- 1. To determine & compare the overall survival time of patients in the two arms.
研究概览
简要总结
Study has completed and final report has been submitted to concerned agencies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
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: o Age: -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 o Hepatic -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). o Renal.
- •Serum Creatinine less than 1.5 times upper limit of normal (ULN) range of Institutional Lab Range.
- •Negative Pregnancy test for women of child bearing potential prior to entry into the trial.
排除标准
- •Patients who have had cytotoxic chemotherapy or radiotherapy prior to entering the study.
- •Patients with symptomatic brain metastasis
- •History of allergic reactions attributed to paclitaxel, cisplatin or mycobacteria or any of their ingredients.
- •Pregnant women or nursing women
- •Uncontrolled intercurrent illness that would limit compliance with study requirements.
- •HIV positive patients
- •Previous splenectomy.
结局指标
主要结局
1. To determine & compare the overall survival time of patients in the two arms.
时间窗: After study completion
2. To determine & compare the effect of this treatment on Quality of life in the two arms.
时间窗: After study completion
次要结局
- 1. To determine & compare the Response rate in the two arms.(2. To study & compare the (hematological) toxicity in the two arms.)
研究者
研究点 (17)
Loading locations...
相似试验
尚未招募
3 期
Study to Evaluate the Long Term Safety and Efficacy of DWP16001 in Patients With Type 2 Diabetes MellitusT2DM (Type 2 Diabetes Mellitus)NCT06141980Daewoong Pharmaceutical Co. LTD.134
已完成
不适用
Clinical Effectiveness of DermACELL AWM in Subjects With Chronic Venous Leg UlcersVenous Leg UlcerNCT03589586LifeNet Health100
尚未招募
3 期
Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency in Pediatric PatientsUreter InjuryNCT06448143Prove pharm18
已完成
不适用
Study to Evaluate Safety and Efficacy of Blanket Used to Prevent Anesthesia Induced HypothermiaAnesthesia Induced HypothermiaInadvertent Perioperative HypothermiaNCT01900067Molnlycke Health Care AB271
招募中
2 期
Clinical Study of Reduced-dose Pomalidomide and Cyclophosphamide Combined With Dexamethasone in the Treatment of Patients With Debilitating RRMMMultiple Myeloma in RelapseNCT06255847Shanxi Bethune Hospital43