NSCLC Clinical Trial
Official title:
Phase II Trial of Stereotactic Body Radiation Therapy Compared With Conventional Fractionated Radiotherapy for Oligometastatic Non-Small Cell Lung Cancer
This protocol is a phase II randomized controlled trial (RCT) evaluating the efficacy of SBRT compared with conventional fractionated radiotherapy for oligometastatic Non-Small Cell Lung Cancer
Non small-cell lung cancer (NSCLC) is the leading cause of cancer-related death worldwide.
Approximately half of all patients with NSCLC present with metastatic disease at the time of
diagnosis, and the predominant pattern of failure in patients with localized NSCLC is
distant metastatic spread. The standard treatment in metastatic disease is cytotoxic
chemotherapy with a mean overall survival between 8-11 months.
Various studies suggest that patients who clinically present with a limited number of
metastases, a term defined as oligometastatic disease, could have a better prognosis of
survival with a radical treatment, than for their counterparts with a greater number of
metastasis. Much of the current clinical outcomes in oligometastatic disease is based on a
series of the retrospective studies.
This is a randomised prospective phase II study based on patients with stage IV
oligometastatic NSCLC according to UICC stage system(version 7,2009) or oligometastatic
disease after radical operation for stage I-III NSCLC. The purpose of this study is to add
more information to the current medical literature about the efficacy and safety of
Stereotactic Body Radiation Therapy (SBRT) compared with conventional fractionated
radiotherapy for oligometastatic non-small cell lung cancer (equal to or less than 5 sites
and equal to or less than 5cm in maximum diameter).
The patients enrolled receive firstly 4-6 cycles chemotherapy (platinum-based doublet
chemotherapy), and achieve response(stable disease or partial response or complete
response). Patients will be randomized into two groups. The control group will undergo the
conventional fractionated radiotherapy to all metastatic sites and the primary tumor. The
experimental group will receive SBRT to primary lesions or metastatic lesions.
The investigators will compare progress free survival(PFS) ,overall survival, incidence of
treatment-related adverse events of the two groups.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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