Lung Cancer Clinical Trial
Official title:
Evaluation of the Benefits of Oral Metronomic Cyclophosphamide in Combination With Standard Cisplatin-etoposide Based Chemotherapy for Squamous Cell Lung Carcinoma
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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