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SBRT in Multi-metastatic NSCLC Patients Which Are Pan-negative for Driver Mutations

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ClinicalTrials.gov Identifier: NCT02940990
Recruitment Status : Unknown
Verified November 2016 by Xiaolong Fu, Shanghai Chest Hospital.
Recruitment status was:  Not yet recruiting
First Posted : October 21, 2016
Last Update Posted : December 1, 2016
Sponsor:
Information provided by (Responsible Party):
Xiaolong Fu, Shanghai Chest Hospital

Brief Summary:
This protocol is a phase II multi-center randomized controlled trial (RCT) evaluating the efficacy of SBRT in multi-metastatic NSCLC patients who are pan-negative for driver mutations.

Condition or disease Intervention/treatment Phase
NSCLC SBRT GM-CSF Radiation: SBRT concurrent with GM-CSF Drug: two-drug chemotherapy containing platinum, including carboplatin/Cisplatin + pemetrexed/docetaxel/paclitaxel/etoposide/gemcitabine/vinorelbine/albumin-bound paclitaxel Phase 2

Detailed Description:

Lung cancer is the leading cause of cancer death. Forty percent of patients are diagnosed as metastatic lung cancer, and about 50% of them are pan-negative for driver mutations. The median overall survival(OS) for these patients is 11 months, and maintenance therapy can only prolong 2 months of OS. The NCCN guidelines recommend 4-6 cycles of chemotherapy with or without maintenance chemotherapy.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2016
Estimated Primary Completion Date : December 2019

Arm Intervention/treatment
Placebo Comparator: 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.
Drug: two-drug chemotherapy containing platinum, including carboplatin/Cisplatin + pemetrexed/docetaxel/paclitaxel/etoposide/gemcitabine/vinorelbine/albumin-bound paclitaxel
two-drug regimen

Experimental: 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.
Radiation: SBRT concurrent with GM-CSF
SBRT and GM-CSF 125ug/m2 for 14 days

Drug: two-drug chemotherapy containing platinum, including carboplatin/Cisplatin + pemetrexed/docetaxel/paclitaxel/etoposide/gemcitabine/vinorelbine/albumin-bound paclitaxel
two-drug regimen




Primary Outcome Measures :
  1. Progress Free Survival (PFS) [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: 2 years ]
  2. Incidence of treatment-related adverse events [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proven non-small-cell lung cancer.
  • 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:

  • Any unstable systemic disease, including active infection, uncontrolled high blood pressure, unstable angina, newly observed angina pectoris within the past 3 months, congestive heart failure (New York heart association (NYHA) class II or higher), myocardial infarction onset six months before included into the group, and severe arrhythmia, liver, kidney, or metabolic disease in need of drug therapy.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02940990


Locations
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China, Shanghai
Shanghai Chest Hospital
Shanghai, Shanghai, China
Contact: Xiaolong Fu, PhD    +862122200000 ext 3602    xlfu1964@126.com   
Sponsors and Collaborators
Shanghai Chest Hospital
Publications of Results:
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Responsible Party: Xiaolong Fu, Director, Department of Radiation Oncology, Shanghai Chest Hospital
ClinicalTrials.gov Identifier: NCT02940990    
Other Study ID Numbers: SCHLC007
First Posted: October 21, 2016    Key Record Dates
Last Update Posted: December 1, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Gemcitabine
Paclitaxel
Etoposide
Vinorelbine
Docetaxel
Albumin-Bound Paclitaxel
Carboplatin
Pemetrexed
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors