Spots Global Cancer Trial Database for Phase II Trial of SBRT Compared With Conventional Radiotherapy for Oligometastatic Non-Small Cell Lung Cancer

Study Description

Brief Summary: 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

Detailed Description: 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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