EUCTR2005-000068-23-GB进行中（未招募）不适用
Phase II trial assessing the impact on instrumental and daily living autonomy of chemotherapy with bi-weekly docetaxel in the treatment of metastatic or locally advanced non-small cell lung cancer in patients over the age of 70. - bi-weekly docetaxel-NSCLC
Fédération Nationale des Centres de Lutte Contre le Cancer0 个研究点目标入组 60 人开始时间: 2005年5月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Subjects aged = 70.
- •2. Histologically or cytologically confirmed non-small cell lung cancer (adenocarcinoma, squamous cell carcinoma, large cell carcinoma or combinations of these non-small cell histologies) of TNM Stage IV or Stage IIIB (pleural T4) that has never been treated by chemotherapy. Including relapse in a non-irradiated area of a previously resected or irradiated primary lung cancer – if there is histological or cytological proof of relapse.
- •3. Metastatic disease measurable by scan or MRI (RECIST criteria).
- •4. First-line metastatic chemotherapy.
- •5. Satisfactory autonomy of daily activity: IADL = 4 or ADL = 4.
- •6. Satisfactory haematological and hepatic function: Hb >10g/dL, neutrophil count > 1.5x109/L, platelets > 100x109/L, transaminases < 1.5N, bilirubin <1.0N, alkaline phosphatases < 2.5N.
- •7. Pre-albumin (transthyretin) > 0.15g/l.
- •8. Creatinine clearance > 30 ml/min calculated according to Cokroft's formula.
- •9. Signed informed consent.
- •10. Life expectancy > 3 months.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Any patient who does not fulfil the inclusion criteria.
- •2. Symptomatic brain metastasis.
- •3. Peripheral neuropathies of grade 2 or greater.
- •4. Other serious illness or medical conditions, including:
- •- congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from trial entry, non-controlled hypertension or high-risk non-controlled arrhythmia,
- •- history of significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures that would hamper understanding and giving informed consent,
- •- active non-controlled infection,
- •- active peptic ulcer, non-controlled diabetes mellitus, inflammatory bowel disease.
- •5. Concurrent treatment with any other anti-cancer therapy.
- •6. Chronic treatment with corticosteroids unless initiated > 6 months prior to trial entry and at low dose (£ 20 mg methylprednisolone per day or equivalent).
- •7. Absolute contraindications for the use of corticosteroids.
- •8. Past or current history of neoplasm other than non-small cell lung cancer, except:
- •- basal cell carcinoma of the skin,
- •- in situ carcinoma of the cervix,
- •- other cancer curatively treated and with no evidence of disease for at least 5 years.
- •9. Patients exhibiting a GDS (geriatric depression scale) score = 12/15.
- •10. History of hypersensitivity to docetaxel or drugs formulated with polysorbate 80.
- •11. Patients who, for family, social, geographic or psychological reasons, cannot be adequately followed up and/or are incapable of undergoing regular controls.
- •12. Concurrent treatment with other investigational drugs. Active treatment as part of another clinical trial within 30 days prior to trial entry
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