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临床试验/NCT01947062
NCT01947062Unknown3 期

Evaluation of the Benefits of Oral Metronomic Cyclophosphamide in Combination With Standard Cisplatin-etoposide Based Chemotherapy for Squamous Cell Lung Carcinoma

Swami Rama Cancer Hospital and Research Institute1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
发起方
入组人数
60
试验地点
1
主要终点
Progression free survival

研究概览

简要总结

Treatment of locally advanced and metastatic squamous cell carcinoma of the lung involves the use of chemotherapy as the therapeutic mainstay. Platinum-etoposide regimens (such as cisplatin-etoposide) are the most commonly used chemotherapeutic regimen, which is delivered intravenously in the standard three-weekly intervals.

Recent interest in oral metronomic chemotherapy has arisen, especially due to its beneficial effects in delaying disease progression among heavily pre-treated patients with various malignancies.

This study attempts to combine the use of metronomic chemotherapy concurrently during standard intravenous chemotherapy.

详细描述

Adenocarinoma and squamous cell carinoma are the two major types of non-small cell lung carcinoma. While patients with adenocarcinoma of the lung have the feasibility of treatment with tyrosine kinase inhibitors, the patients with squamous cell carcinoma can only be treated with standard chemotherapy due to the ineffectiveness of tyrosine kinase inhibitors. Thus, the current standard is to treat patients of squamous cell lung cancers with standard intravenous chemotherapy, which is mostly delivered once in three weeks.

Metronomic chemotherapy, meaning the delivery of low doses of chemotherapy, often by an oral approach, on a daily basis so as to maintain a low but definite level of the chemotherapy has received great interest in recent times due to its beneficial effects in terms of extending progression free survival among patients of various malignancies, even after failure with previous conventional therapies. Metronomic chemotherapy is proposed to be active by alternate mechanisms, such as the predominant anti-angiogenic effect, in contrast to the cytotoxic and genotoxic effects of standard chemotherapy.

Metronomic chemotherapy with oral cyclophosphamide has been shown to extend progression free survival when used as a single agent in various malignancies. Given the fact that progression after varying time spans is a rule (rather than the exception) among patients of squamous cell lung cancer being treated with conventional chemotherapy, we have intended to combine the use of oral metronomic chemotherapy given concurrently with standard intravenous cisplatin-etoposide based chemotherapy. We intend to observe a prolongation of progression free survival.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Histopathologically proven squamous cell carcinoma of the lung
  • Surgically unresectable or metastatic disease

排除标准

  • Severe life limiting diabetes, hypertension or cardiac co-morbidities
  • Co-existing tuberculosis
  • Brain metastases at presentation
  • Non-consenting patients
  • Previously treated with any regimen of chemotherapy for existing or previous malignancy

研究组 & 干预措施

Standard intravenous chemotherapy

Active Comparator

Patients will receive standard intravenous chemotherapy based on cisplatin and etoposide.

干预措施: Intravenous Cisplatin & etoposide (Drug)

Intravenous with metronomic chemotherapy

Experimental

Patients will receive both intravenous (cisplatin and etoposide based) and metronomic chemotherapy (with oral cyclophosphamide).

干预措施: Intravenous Cisplatin & etoposide along with oral cyclophosphamide (Drug)

结局指标

主要结局

Progression free survival

时间窗: 12 months on average

次要结局

  • Response rate(12 months on average)

研究者

发起方
Swami Rama Cancer Hospital and Research Institute
申办方类型
Industry
责任方
Principal Investigator
主要研究者

Swaroop Revannasiddaiah

Assistant Professor, Radiotherapy & Clinical Oncology

Swami Rama Cancer Hospital and Research Institute

研究点 (1)

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