KCT0001060终止未知
Phase 3 Study of Pemetrexed, Cisplatin, and RadiotherapyFollowed by Consolidation Pemetrexed versus Etoposide,Cisplatin, and Radiotherapy Followed by ConsolidationCytotoxic Chemotherapy of Choice in Patients withUnresectable, Locally Advanced, Stage III Non-Small CellLung Cancer Other than Predominantly Squamous CellHistology
Eli Lilly Korea0 个研究点目标入组 15 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 终止
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •[1] Present with histologically proven or cytological diagnosis of NSCLC that is
- •defined as other than predominantly squamous cell histology (squamous cell
- •and/or mixed small cell, non-small cell histology is not permitted)
- •[2] Stage IIIA or IIIB NSCLC (without malignant pleural/pericardial effusion).
- •The presence of pleural/pericardial fluid is presumed indicative of metastatic
- •disease unless proven otherwise.
- •NOTE: A pleural effusion fluid that is present on both a CT chest scan and
- •routine chest x-ray requires a pleuracentesis to ensure the effusion is
- •cytologically negative. Patients with effusions that are exudates are excluded
- •even if the effusions are cytologically negative. Patients with effusions that
- •are not visible on routine chest x-ray or are too small to be tapped safely may
- •be entered on this study, provided the remaining inclusion/exclusion criteria
- •Sites are encouraged to obtain tissue confirmation of mediastinal nodal
- •involvement. However, mediastinal nodal involvement can be declared
- •present in situations where there is a mass of lymph nodes present in which
- •the margins of these nodes are indistinct. In situations where the nodes have
- •distinct margins, the size of the shortest axis of at least 1 node must be
- •>=2.0 cm (CT/MRI). Cases in which the distinct nodes all have short axis of
- •<2.0 cm must have pathologic confirmation of disease presence for patients to
- •be declared eligible.
- •Patients with Stage IIIB NSCLC who have supraclavicular nodal involvement
- •may be entered into this study. However, patients with cervical nodes are not
- •permitted. The upper border of supraclavicular nodes must not extend above
- •the upper border of the lateral end of the clavicle, extended medially.
- •[3] Have an ECOG performance status score of 0 or 1
- •[4] Have tumor lesion measurable according to Response Evaluation Criteria in
- •Solid Tumors (RECIST; Therasse et al. 2000) or evaluable disease on CT
- •scan. PET scans and ultrasounds should not be used for lesion measurements
- •[5] Have adequate pulmonary function defined as a forced expiratory volume in
- •1 second (FEV1) >50% of predicted normal volume and the carbon monoxide
- •lung diffusing capacity (DLCO) >40% of predicted normal value. Patients for
- •whom DLCO measurements are not available will be deemed to have
- •adequate oxygen transfer if their resting capillary/arterial blood gas on room
- •air reveals an oxygen pressure (pO2) >60 mmHg.
- •[6] Have normal organ and marrow function, including the following:
- •Bone marrow reserve: leukocytes >=3.0 x 109/L, absolute neutrophil count
- •>=1.5 x 109/L, platelets >=100 x 109/L, and hemoglobin >=9 g/dL
- •Hepatic: total bilirubin <=1.5 times the upper limit of normal (ULN), liver
- •transaminases: alkaline phosphatase (AP), aspartate transaminase (AST or
- •SGOT), and alanine transaminase (ALT or SGPT) <=1.5 times ULN.
- •Patients with liver transaminases between 1 and 1.5 ULN must have no
- •indication of liver metastases on contrast-enhanced CT scan
- •Renal: creatinine <=1.5 times ULN, and calculated creatinine clearance
- •>=45mL/min, based on the Cockcroft-Gault formula (Cockcroft and Gault
- •[7] Weight loss <=10% in the preceding 3 months
- •[8] Estimated life expectancy >12 weeks
- •[9] Age >=18 years
- •[10] Signed informed consent from the patient
- •[11] For women: must be surgically sterile, postmenopausal, or compliant with a
- •medically approved contraceptive regimen (for example, intrauterine device
- 另有 1 项未显示
排除标准
- •[13] Have uncontrolled intercurrent illness including, but not limited to, ongoing or
- •active infection or psychiatric illness/social situations that would limit
- •compliance with study requirements
- •[14] Have myocardial infarction within the preceding 6 months or symptomatic
- •congestive heart failure, unstable angina pectoris, or uncontrolled cardiac
- •[15] Have received treatment within the last 30 days with any other investigational
- •agents that have not received regulatory approval for any indication at the
- •time of study enrollment
- •[16] Have disease considered for surgical treatment as part of their care plan, such
- •as Pancoast or superior sulcus tumors
- •[17] Had prior thoracic radiation. However, other prior radiotherapy is allowed.
- •Patients must have recovered from the toxic effects of the treatment prior to
- •study enrollment. Patients may not have received whole pelvis radiation or
- •radiation to more than 25% of their bone marrow (Cristy and Eckermann
- •Prior radiotherapy must have been completed at least 30 days prior to study
- •[18] Patients whose radiation treatment plans are likely to encompass a volume of
- •whole lung receiving >=20 Gy in total (V20) of more than 35% of lung volume.
- •In some circumstances the V20 can exceed 35% (see Section 5.2.1.1.6.7)
- •[19] Concurrent cancer from another primary site requiring treatment of any kind
- •within the past 5 years. Exemptions to this will be permitted on a case-bycase
- •basis after prior approval by the lead Lilly physician or designate if the
- •investigator believes the patient’s risk of recurrence and death is very low.
- •Curatively treated nonmelanoma skin cancer or in situ carcinoma of any
- •origin is allowed. Patients with recurrence of a previously resected lung
- •cancer or who have a second primary lung cancer are ineligible.
- •[20] Are pregnant, breast feeding, or unwilling to use adequate contraception
- •[21] Patients with immune deficiency (for example, HIV positive)
- •[22] Are unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs
- •(NSAIDs), other than an aspirin dose <=1.3 grams per day, for at least 2 days
- •(5 days for long-acting agents [for example, piroxicam]) before, during, and
- •for at least 2 days after administration of pemetrexed
- •[23] Are unable/unwilling to take folic acid, vitamin B12, and dexamethasone
- •[24] Have recent contraindication or rejection of the use of corticosteroids, or
- •concomitant yellow fever vaccination (within 30 days of study enrollment)
- •[25] Have evidence of clinical hearing loss. Patients who have hearing loss based
- •solely on conduction deficits demonstrated on audiogram may be entered into
- •[26] Known hypersensitivity to pemetrexed, cisplatin, etoposide or any of the
- •excipients in these medicinal products
- •[27] Had prior systemic chemotherapy for lung cancer.
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