Phase II Study of Stereotactic Body Radiation Therapy (SBRT) After First-Line Chemotherapy for Metastatic NSCLC
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Non-Small-Cell Lung Carcinoma
- Sponsor
- Wake Forest University Health Sciences
- Enrollment
- 29
- Locations
- 2
- Primary Endpoint
- Progression-free Survival
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
This protocol is a single arm phase II multi-center trial evaluating the efficacy of Stereotactic Body Radiation Therapy (SBRT) in patients with oligometastatic non-small cell lung cancer (NSCLC) with response or stable disease after 4 cycles of first-line chemotherapy. The core hypothesis tested is that SBRT after 4 cycles of first-line chemotherapy is feasible, safe, provides durable local control of treated lesions and improves time to progression compared to historical controls. Patients are eligible for enrollment if they have metastatic NSCLC with ≤5 lesions amenable to SBRT.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with AJCC sixth edition metastatic non-small cell lung carcinoma
- •Pathologic diagnosis of stage 4 non-small cell lung cancer prior to enrollment.
- •Patients must have response or stable disease by RECIST criteria after 4 cycles of first-line chemotherapy
- •Maximum of number of lesions per patient will be 5 total. .
- •Patients with solitary brain metastases previously treated with surgery or stereotactic radiosurgery (+/- WBRT) and currently controlled at the time of study enrollment are also eligible. Patients with history of brain metastases must have an MRI showing no active brain metastases within 80 days of study enrollment. Patients with a history of brain metastases may have up to 5 extracranial sites of disease except for those with an untreated primary tumor where section 3.1.3.3 will also apply.
- •Patients with newly diagnosed stage IV NSCLC with an untreated primary must no more than 3 active extracranial metastatic lesions other than the primary site and regional lymph nodes.
- •Age ≥ 18 years old
- •Performance Status 0-2 (ECOG)
- •A signed study specific consent form is required.
- •Lung (only applies to patients with active lung lesions)
Exclusion Criteria
- •Primary tumor progression on first-line chemotherapy
- •Patients with complete response to first-line chemotherapy with no measurable target for SBRT
- •\>5 metastatic lesions or \>3 metastatic lesions in patients with an untreated primary site are ineligible (ipsilateral hilar and mediastinal lymph nodes are considered part of an untreated primary site and are not counted as metastatic lesions)
- •Solitary brain metastases and an untreated node positive primary tumor, without other extracranial metastases amenable to SBRT are ineligible
- •Retreatment of previously irradiated tumor will be excluded per 3.1.9.2 above.
- •Mediastinal lymph nodes involving multiple mediastinal nodal stations or N3 disease are ineligible.
- •Pleural effusion known to be malignant or visible of chest xray.
- •Untreated brain metastases
- •Bilateral adrenal metastases
- •Metastases in other sites not considered amenable to SBRT
Outcomes
Primary Outcomes
Progression-free Survival
Time Frame: up to 2 years
Actuarial progression-free survival will be determined using the product-limit method of Kaplan and Meier and will be reported with an exact 95% confidence interval. Using the RECIST criteria including progression of the protocol treated tumors, non-protocol treated tumors and the development of new metastatic disease. Only protocol treated tumors will be determined by RECIST defined as complete lesion disappearance or \<25%or original size; partial \>30% decrease of target lesion; stable \<30% decreased of target lesion and; local failure increase \>20% of target lesion. Non-protocol tumor progression will be determined by the treating physician. Measured by imaging every 3 months.
Secondary Outcomes
- To Assess Physical Function for This Cohort of Patients(up to 3 months after treatment)
- Number of Participants With Local Control(up to 2 years)
- Overall Survival(up to 4 years)
- Impact of Treatment on Quality of Life (FACT-L)(up to 3 months after treatment)