EUCTR2013-001494-24-ES进行中（未招募）不适用
A Randomized Prospective Trial of Adjuvant Chemotherapy in Patients with Completely Resected Stage I Non-Squamous Non-Small Cell Lung Cancer Identified as High Risk by the Pervenio? Lung RS Assay
Encore Clinical, Inc0 个研究点目标入组 1,050 人开始时间: 2013年9月16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
- 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 (the informed consent document must have been approved by the appropriate Institutional Review Board/Independent Ethics Committee (IRB/IEC). Consent
- •must be obtained and signed and witnessed PRIOR to any study specific activity.
- •2. Age ? 18 years
- •3. Able to comply with the protocol, including follow-up especially for anticipated length of study (i.e. 5 years from the initiation of enrollment).
- •4. Histologically documented completely resected (R0) Stage I non-squamous NSCLC. Eligible resections include lobectomy, bi-lobectomy, sleeve lobectomy and pneumonectomy.
- •Resections via segmentectomy or wedge resection will not be eligible. Complete resection must also be accompanied, at a minimum, by intra-operative systematic mediastinal lymph
- •node sampling. Systematic sampling is defined as removal of at least one representative lymph node each from levels 4 and 7 for a right-sided cancer and from levels 5 and/or 6 and 7 for left-sided cancers. Complete mediastinal lymph node dissection (MLND), however, is preferred, and is defined as resection of all lymph nodes at those same levels for right- and
- •left-sided cancers.
- •5. Adequate tissue sample available for Pervenio testing (paraffin block with tumor occupying at least 25% of the tissue surface area)
- •6. Life expectancy excluding NSCLC diagnosis ? 5 years
- •7. ECOG performance status 0-1
- •8. Adequate haematological function*:
- •a. Absolute neutrophil count (ANC) ? 1500 cells/mm3 AND
- •b. Platelet count ? 100000 cells/mm3 AND
- •c. Haemoglobin ? 9 g/dL (may be transfused to maintain or exceed this level)
- •9. Adequate liver function*:
- •a. Total bilirubin < 1.5 x upper limit of normal (ULN) AND
- •b. Aspartate amiotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x ULN
- •10. Adequate renal function*, with Serum creatinine ? 1.5 x ULN
- •11. Completely healed incisions
- •*Note: all laboratory values must be obtained within 14 days prior to randomization
- •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 700
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 350
排除标准
- •1. Final pathologic diagnosis on resected specimen is squamous cell histology
- •2. Evidence of greater than stage I pathologic staging, including loco-regional regional (hilar) or mediastinal lymph node involvement or nodal enlargement that has not been biopsied, or
- •of distant metastatic disease (lesions that have been biopsy-proven or that are suspicious on brain MRI and/or PET scan)
- •3. Evidence of incomplete resection, including positive resection margins, additional suspect nodules
- •4. Pregnant or lactating women
- •5. Women with an intact uterus (unless amenorrhoeic for the previous 24 months) unwilling to use an effective means of contraception (including oral contraceptive, intrauterine
- •contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) during the study and for a period of 6 months following the last
- •administration of study chemotherapy. Men who do not agree to use effective contraception during the study and for a period of 90 days following the last administration of study chemotherapy.
- •6. Active infection, either systemic or at site of primary resection
- •7. Any pre-operative systemic chemotherapy or treatment with an anti-cancer agent
- •8. Any pre-or post operative radiotherapy to primary site or elsewhere
- •9. Malignancies other than NSCLC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate
- •cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent
- •10. Treatment with any investigational drug or participation in another clinical trail within 28 days prior to enrollment.
- •11. Known hypersensitivity to any of the study treatment agents.
- •12. Evidence of any other disease including infection (see above) such as neurologic or metabolic dysfunction or physical examination finding giving reasonable suspicion of a
- •disease or condition that contraindicates the use of systemic cytotoxic chemotherapy or puts the patient at high risk for treatment related complications.
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