A Prospective Single-arm Multi-center Phase II Study: Assessment of the Safety and Abscopal Effects of SBRT in Combination With rhGM-CSF for Stage IV NSCLC Patients Who Failed in Second-line Chemotherapy
Overview
- Phase
- Phase 2
- Intervention
- Stereotactic body radiotherapy
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Sponsor
- Wuhan University
- Locations
- 1
- Primary Endpoint
- abscopal effect rate
- Status
- Withdrawn
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to determine whether stereotactic body radiotherapy (SBRT) combined with recombined human granulocyte-macrophage colony stimulating factor(rhGM-CSF) is safe, effective in the treatment of stage IV NSCLC patients who failed in second-line chemotherapy.
Detailed Description
Metastasis lesion will be treated with a SBRT of 50Gy/5F from day 1 to day 5 in one cycle.Subcutaneous injection of human recombined granulocyte-macrophage colony stimulating factor (125ug/m² per day) will be executed from day 1 to day 14 in this cycle. Another metastasis lesion will be treated likewise concurrently with rhGM-CSF in a consecutive cycle. Efficacy evaluation,especially abscopal effect evaluation, will be conducted at the end of therapy and every month after that. Adverse events will be recorded according to NCI-CTC version 4.03.
Investigators
Conghua Xie,MD,PhD
Professor,MD,PhD,Director of Department of Radiation and Medical Oncology,Zhongnan Hospital
Wuhan University
Eligibility Criteria
Inclusion Criteria
- •Histologically proven non-small-cell lung cancer.
- •Stage IV according to UICC stage system(version 7,2009).
- •Progression after standard second-line chemotherapy.
- •At least Three evaluable lesions among which at least two must be suitable for SBRT.
- •ECOG performance status 0-
- •Expected lifespan ≥3 months.
- •Stable lab values:
- •Hematological: Absolute neutrophil count (ANC) ≥1.5×109/L, Platelets ≥100×109/L, Hemoglobin ≥9 g/dL Renal: Creatinine OR Measured or calculated creatinine clearance (CrCl) (glomerular filtration rate \[GFR\] can also be used in place of creatinine or CrCl) ≤1.5× the upper limit of normal (ULN) OR ≥60 mL/min for patient with creatinine levels \>1.5× institutional ULN Hepatic: Total bilirubin ≤1.5×ULN OR Direct bilirubin ≤ULN for patients with total bilirubin levels \>1.5×ULN, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN OR ≤5×ULN for patients with liver metastases ,globulin≥20 g/L, albumin≥30 g/L.
- •Female subjects must have a negative urine or serum pregnancy test within 72 hours prior to taking study drug if of childbearing potential.
- •Able to understand and give written informed consent and comply with study procedures.
Exclusion Criteria
- Not provided
Arms & Interventions
SBRT+GM-CSF
Metastasis lesion will be treated with a SBRT of 50Gy/5F from day 1 to day 5 in a cycle of 21 days.Subcutaneous injection of human recombined granulocyte-macrophage colony stimulating factor (125ug/m² per day) will be executed from day 1 to day 14 in this cycle. Another metastasis lesion will be treated likewise concurrently with rhGM-CSF in a consecutive cycle.
Intervention: Stereotactic body radiotherapy
SBRT+GM-CSF
Metastasis lesion will be treated with a SBRT of 50Gy/5F from day 1 to day 5 in a cycle of 21 days.Subcutaneous injection of human recombined granulocyte-macrophage colony stimulating factor (125ug/m² per day) will be executed from day 1 to day 14 in this cycle. Another metastasis lesion will be treated likewise concurrently with rhGM-CSF in a consecutive cycle.
Intervention: rhGM-CSF
Outcomes
Primary Outcomes
abscopal effect rate
Time Frame: at the time point of 4 weeks after completion of rhGM-CSF
Secondary Outcomes
- overall survival(2 years)
- Incidence of Adverse events(2 years)
- progression free survival(2 years)
- objective response rate(2 years)
- abscopal effect rate(at the time point of 2 months after completion of rhGM-CSF)
- Incidence of treatment-related adverse events(2 years)
- Incidence of immune-related adverse events(2 years)