Phase III Multicenter Randomized Trial Comparing Adjuvant Pharmacogenomic-Driven Chemotherapy versus Standard Adjuvant Chemotherapy in Completely Resected Stage II-IIIA Non-Small Cell Lung Cancer. - International TAilored Chemotherapy Adjuvant

Azienda Ospedaliero Universitaria ''San Luigi Gonzaga''0 个研究点目标入组 700 人开始时间: 2008年10月1日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•All patients must have histological evidence of pathological stage II-IIIA non-small cell lung cancer after radical surgery. All surgical margins of resection must be negative for tumor (R0). Patients must be ≥ 18 years of age and provide written voluntary informed consent. Patients must have an ECOG PS of 0 ? 1, not have received any systemic chemotherapy or radiation therapy prior to resection of lung cancer and an interval of 45 to 60 days must have been elapsed between surgery and the start of adjuvant therapy.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•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

•Patients must not have any prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the patient has been disease-free for at least 5 years prior to enrollment, peripheral neuropathy ³ common toxicity criteria Grade 1. In addition, patients must not have had recent (within 30 days of study treatment) or concurrent yellow fever vaccination, a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV. Patients must be able to interrupt concurrent treatment with aspirin or other non-steroidal anti-inflammatory agents, other than an aspirin dose ≤ 1.3 grams per day, for a 5-day period (8-day period for longacting agents, such as piroxicam) and must be willing and able to take folic acid, vitamin B12 supplementation or corticosteroids. Patients must have no history of severe hypersensitivity reactions to products containing cremophor.

发起方

Azienda Ospedaliero Universitaria ''San Luigi Gonzaga''