SBRT in Multi-metastatic NSCLC Patients Which Are Pan-negative for Driver Mutations
NCT ID: NCT02940990
Last Updated: 2016-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
50 participants
INTERVENTIONAL
2016-11-30
Brief Summary
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Detailed Description
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Published data showed that radiotherapy modulates tumor phenotypes, enhances antigen presentation and tumor immunogenicity. The regression of out-field lesions was termed as "abscopal effect". The combination of radiotherapy with immunotherapeutic agents may promote the host anti-tumor immune response and increase the rate of abscopal effect.Published data showed that abscopal effect appeared in 20%-30% patients with metastatic malignant tumors who were treated with the combination of SBRT and GM-CSF.
The investigators evaluate the efficacy of the combination of SBRT and GM-CSF in the multi-metastatic NSCLC participants who are pan-negative for driver mutations. Patients enrolled will be randomized into two groups. The control group will receive the standard regimen as NCCN recommends. The experimental group will receive both the standard chemotherapy and the extra SBRT to primary lesions or metastatic lesions combined with GM-CSF. The investigators compare progress free survival(PFS) of the two groups.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A
Participants in the Group A will receive 4-6 cycles of standard two-drug chemotherapy. After that, clinical observation or maintenance chemotherapy will be given.
two-drug chemotherapy containing platinum, including carboplatin/Cisplatin + pemetrexed/docetaxel/paclitaxel/etoposide/gemcitabine/vinorelbine/albumin-bound paclitaxel
two-drug regimen
Group B
Participants in the Group B will also receive 4-6 cycles of standard two-drug chemotherapy. However, they will receive an additional treatment of SBRT to primary lesions or metastatic lesions combined with GM-CSF.
SBRT concurrent with GM-CSF
SBRT and GM-CSF 125ug/m2 for 14 days
two-drug chemotherapy containing platinum, including carboplatin/Cisplatin + pemetrexed/docetaxel/paclitaxel/etoposide/gemcitabine/vinorelbine/albumin-bound paclitaxel
two-drug regimen
Interventions
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SBRT concurrent with GM-CSF
SBRT and GM-CSF 125ug/m2 for 14 days
two-drug chemotherapy containing platinum, including carboplatin/Cisplatin + pemetrexed/docetaxel/paclitaxel/etoposide/gemcitabine/vinorelbine/albumin-bound paclitaxel
two-drug regimen
Eligibility Criteria
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Inclusion Criteria
* Stage IV according to UICC stage system(version 7,2009).The number of metastatic lesions\>5
* Pan-negative for driver mutations including EGFR ALK ROS1 c-MET
* At least Three evaluable lesions among which at least two must be suitable for SBRT.
* ECOG performance status 0-2.
* Expected lifespan ≥3 months.
* No brain metastasis in MRI.
* No liver metastasis in abdominal CT or MRI.
* No malignant pleural effusion or pericardial effusion from chest CT and/or pathology.
* 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.
\- Able to understand and give written informed consent and comply with study procedures.
Exclusion Criteria
* Previously diagnosed with immunodeficiency disease.
* Human immunodeficiency virus (HIV) infection.
* Women in pregnancy or lactation .
* Patients with mental illness, considered as "can't fully understand the issues of this research".
* other Cancer history.
* Histologically confirmed small cell carcinoma or other non NSCLC compositions in the cancer tissue.
* Brain metastasis or liver metastasis or malignant pleural effusion or pericardial effusion.
* Allergy of rhGM-CSF and its accessories.
* Contraindications to GM-CSF treatment.
18 Years
ALL
No
Sponsors
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Shanghai Chest Hospital
OTHER
Responsible Party
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Xiaolong Fu
Director, Department of Radiation Oncology
Locations
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Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Countries
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Facility Contacts
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Xiaolong Fu, PhD
Role: primary
References
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Golden EB, Chhabra A, Chachoua A, Adams S, Donach M, Fenton-Kerimian M, Friedman K, Ponzo F, Babb JS, Goldberg J, Demaria S, Formenti SC. Local radiotherapy and granulocyte-macrophage colony-stimulating factor to generate abscopal responses in patients with metastatic solid tumours: a proof-of-principle trial. Lancet Oncol. 2015 Jul;16(7):795-803. doi: 10.1016/S1470-2045(15)00054-6. Epub 2015 Jun 18.
Bernstein MB, Krishnan S, Hodge JW, Chang JY. Immunotherapy and stereotactic ablative radiotherapy (ISABR): a curative approach? Nat Rev Clin Oncol. 2016 Aug;13(8):516-24. doi: 10.1038/nrclinonc.2016.30. Epub 2016 Mar 8.
Stamell EF, Wolchok JD, Gnjatic S, Lee NY, Brownell I. The abscopal effect associated with a systemic anti-melanoma immune response. Int J Radiat Oncol Biol Phys. 2013 Feb 1;85(2):293-5. doi: 10.1016/j.ijrobp.2012.03.017. Epub 2012 May 5.
Daly ME, Monjazeb AM, Kelly K. Clinical Trials Integrating Immunotherapy and Radiation for Non-Small-Cell Lung Cancer. J Thorac Oncol. 2015 Dec;10(12):1685-93. doi: 10.1097/JTO.0000000000000686.
Abuodeh Y, Venkat P, Kim S. Systematic review of case reports on the abscopal effect. Curr Probl Cancer. 2016 Jan-Feb;40(1):25-37. doi: 10.1016/j.currproblcancer.2015.10.001. Epub 2015 Oct 9.
Other Identifiers
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SCHLC007
Identifier Type: -
Identifier Source: org_study_id