EUCTR2013-001494-24-FR进行中（未招募）1 期
A Randomized Prospective Trial of Adjuvant Chemotherapy in Patients with Completely Resected Stage I or IIA Non-Squamous Non-Small Cell Lung Cancer Identified as High or Intermediate Risk by a 14-Gene Prognostic Assay - 14-GENE
IFCT0 个研究点目标入组 1,050 人开始时间: 2013年12月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,050
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. Written informed consent
- •2. Age = 18 years
- •3. Able to comply with the protocol, including acceptable candidacy for adjuvant chemotherapy and likely compliance with follow-up for anticipated length of study (i.e. 5 years from the initiation of enrollment).
- •4. Histologically documented completely resected (R0) Stage I or IIA non-squamous NSCLC (per 8th edition, TNM staging system)
- •5. Adequate tissue sample for the 14-Gene Prognostic Assay
- •6. Life expectancy excluding NSCLC diagnosis = 5 years
- •7. ECOG performance status 0-1
- •8. Adequate haematological function:
- •Absolute neutrophil count (ANC) = 1500 cells/mm3 AND
- •Platelet count = 100000 cells/mm3 AND
- •Haemoglobin = 9 g/dL (may be transfused to maintain or exceed this level)
- •9. Adequate liver function:
- •Total bilirubin < 1.5 x upper limit of normal (ULN) AND
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x ULN
- •10. Adequate renal function, with Serum creatinine = 1.5 x ULN
- •11. Completely healed incisions
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1. Final pathologic diagnosis of pure squamous cell, pure small cell, or pure neuroendocrine histology, or any combination of only these three histologies
- •2. Evidence of greater than stage IIA pathologic staging
- •3. Evidence of incomplete resection
- •4. Pregnant or lactating women
- •5. Unwilling to use an effective means of contraception
- •6. Active infection, either systemic or at site of primary resection
- •7. Systemic chemotherapy or anti-cancer agent within 5 years prior to enrollment
- •8. Any pre- or post-operative radiotherapy
- •9. Malignancies other than NSCLC within 5 years prior to randomization, except for adequately treated CIS of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically, ductal carcinoma in situ treated surgically
- •10. Treatment with any investigational drug or participation in another clinical trial within 28 days prior to enrollment
- •11. Known hypersensitivity to any of the study treatment agents
- •12. Evidence of any other disease including infection that
- •13. contraindicates the use of systemic cytotoxic chemotherapy or puts the patient at high risk for treatment related complications
研究者
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