A Randomized Cost-minimization Trial Comparing Pemetrexed (Alimta®) Versus Docetaxel (Taxotere®) as Second Line Treatment in Advanced Non Small Cell Lung Cancer (NSCLC): Study 05-06 of Groupe Français de Pneumo-Cancérologie (GFPC).
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 17
研究概览
简要总结
The indication of chemotherapy of 2nd line treatment in advanced non small cell lung cancer is now well established. The two treatments of reference are pemetrexed (alimta) and docetaxel (taxotere). Effectiveness and toxicity of the two drugs are largely documented in the literature.
Economic analyses are currently one of the criteria used in medical decision, beside effectiveness, quality of life and toxicities.
However, Economical comparison shows significant variations in the acquisition costs of the two drugs. Consequently, it appears interesting to carry out a randomized prospective study with on exclusive economical criteria of judgment.
As there is no difference in the effectiveness between the two treatments, a cost-minimization analysis will be carried out to appreciate the ratio benefit/risks from an economical point of view (payer).
详细描述
The main objective of this trial is of to compare, economically, the use of pemetrexed (alimta®) in 2nd line chemotherapy in advanced non-small cell lung cancer versus docetaxel (taxotere®).
150 patients will be selected for this trial which, after checking the eligibility criteria, will be randomized in two arms:
- Arm A: Taxotere 75 mg/m² every 3 weeks.
- Arm B : Alimta 500 mg/m² every 3 weeks.
Inclusion assessment.
- Clinical signs
- Blood cell count, renal and hepatic function (within 8 days)
- Chest X ray, CT scan or MRI scan, abdominal echography, and/or abdominal scan (within 28 days)
- Brain scan, bone scintigraphy and/or bone x ray (within 28 days)
- Bronchial endoscopy (within 28 days)
- EKG, echocardiography according to history
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically proved stage IV or pleural stage III NSCLC (neoplastic pleurisy confirmed).
- •Metastatic relapses allowed if asymptomatic.
- •Progressive disease during or after a standard first line platinum-based chemotherapy (without taxotere or alimta)
- •Only one chemotherapeutic line including adjuvant and neo adjuvant treatment.
- •Irradiation allowed if < 25% bone medulla . It may be ended 2 weeks before the second line treatment.
- •At least one measurable target lesion according to recist criteria in non previously irradiated area.
- •Performance status <=2
- •Age between 18 and 70 years
- •Life expectancy > 12 weeks.
- •Normal hepatic function
- •Normal renal function
- •Normal serum calcium
- •Absolute neutrophil count>1.5 gigal/l,platelets>100 gigal/l,haemoglobin>9.0 g/dl
- •Written informed consent
排除标准
- •SCLC, bronchioli-alveolar and neuro-endocrine carcinoma.
- •Symptomatic brain metastases.
- •Superior vena cava syndrome.
- •Uncontrolled fluid retention in the third space (pleural or ascitic collection)
- •Prior chemotherapy without platin
- •Other concomitant diseases: heart failure, angina pectoris, tachyarrythmia, recent myocardial infarction, active infections.
- •Peripheral neuropathy grade ≥
- •Past or concomitance of another cancer except baso-cellular carcinoma of the skin or in situ cervical carcinoma.
- •Hypersensitivity to docetaxel or polysorbate
- •Unability or unwillingness to take folic acid, vitamin B12 supplementation or corticosteroids.
- •Pregnancy or breast feeding.
- •Follow-up of the patient impossible.
- •Prisoners
研究组 & 干预措施
ALIMTA
干预措施: Alimta® (Drug)
Docetaxe
干预措施: Taxotere® (Drug)