Maintenance Gemcitabine in the Chinese Advanced Lung Cancer

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状态

赞助商

Tongji University

合作者

Shanghai Pulmonary Hospital, Shanghai, China

临床试验: NCT01336192

BioSeek: NCT01336192

关键词

抽象

Lung cancer, the most common cancer worldwide, remains the leading cause of cancer death. Approximately two-thirds of all patients with newly diagnosed non-small-cell lung cancer (NSCLC) present with advanced stage that palliative chemotherapy is the only appropriate measure. The standard treatment for this patient population consists of third generation platinum-based doublet regimen for no more than 6 cycles followed by watch and wait until disease progression (PD) before the administration of second-line and third-line systemic anticancer therapeutic agents. Patients who go on to receive second-line therapy represent a selected subgroup with an improved overall prognosis.

Switch maintenance therapy with pemetrexed or erlotinib in patients with advanced NSCLC without PD after first-line chemotherapy has been confirmed to improve progression free survival (PFS) and overall survival (OS) significantly compared with placebo in two large randomized controlled studies. However, continuation gemcitabine maintenance therapy in this setting yields conflicting results in the west, i.e.showing a prolongation of PFS without OS improvement. Thus, we investigate the efficacy and safety of continuation of gemcitabine maintenance therapy for patients with metastatic NSCLC with ECOG performance status of 0-1 and without PD after four cycles of first-line chemotherapy with gemcitabine and cisplatin in China.

日期

最后验证:	03/31/2011
首次提交:	04/06/2011
提交的预估入学人数:	04/12/2011
首次发布:	04/14/2011
上次提交的更新:	04/12/2011
最近更新发布:	04/14/2011
实际学习开始日期:	03/31/2011
预计主要完成日期:	03/31/2012
预计完成日期:	03/31/2013

状况或疾病

Non Small Cell Lung Cancer

干预/治疗

Drug: Maintenance gemcitabine

相

相 4

手臂组

臂	干预/治疗
No Intervention: Best supportive care Best supportive care
Experimental: Maintenance gemcitabine Maintenance therapy of gemcitabine alone	Drug: Maintenance gemcitabine Gemcitabine 1250mg/m^2 Day 1 and 8, 28 days per cycle until PD

资格标准

有资格学习的年龄	18 Years 至 18 Years
有资格学习的性别	All
接受健康志愿者	是
标准	Inclusion Criteria: - Histologic or cytologic confirmed diagnosis of Stage IV NSCLC according to 2009 the seventh edition of TNM staging of lung tumors. - No disease progression after four cycles of first-line chemotherapy with gemcitabine plus cisplatin (running period) within one month before the enrollment. - Brain metastases are permitted if treated with full course of whole brain radiotherapy without the presence of symptomatic central nervous system metastases. - ECOG score 0-1 Exclusion Criteria: - First-line chemotherapy other than combination treatment of gemcitabine plus cisplatin - Other therapy including targeted therapy, immunotherapy and prior radiotherapy for the treatment of the primary tumor prior to enrollment. - Active infection - Inadequate liver and renal function. - Serious concomitant systemic disorder incompatible with the study. - Second primary malignancy (except in situ carcinoma of the cervix, adequately treated basal cell carcinoma of the skin, T1 vocal cord cancer in remission, or prior malignancy treated more than 5 years prior enrollment without recurrence) - Presence of the pregnancy

结果

主要结果指标

1. Progression free survival [12 months]

From the start of maintenance therapy or Best Suppotive Care(BSC) until the date of documented progressive disease or death from any cause

次要成果指标

1. Overall Survival [18 months]

From the start of maintenance therapy or BSC until the date of documented death from any cause

2. Response Rate [approximately 4 weeks]

From the start of maintenance therapy or BSC until the date of documented progressive disease

3. Time to The Progression [18 months]

From the start of maintenance therapy or BSC until the date of documented progressive disease

4. Health Related Quality of Life [Approximately 4 weeks]

From the start of maintenance therapy or BSC until the date of documented progressive disease or the termination of study

5. Number of Participants with treatment-related grade III/IV adverse events [6 months]

frequency and severity of adverse events and laboratory abnormalities

Maintenance Gemcitabine in the Chinese Advanced Lung Cancer

关键词

lung neoplasms

neoplasms

抗癌药

抗真菌药

化学疗法

抽象

日期

状况或疾病

干预/治疗

相

手臂组

资格标准

结果

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