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Chemotherapy Combination With Local Radiotherapy and rhGM-CSF for Oligometastatic Stage IV NSCLC Patients (CRAGMOLC)

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ClinicalTrials.gov Identifier: NCT03489616
Recruitment Status : Unknown
Verified March 2018 by Jinming Yu, Shandong Cancer Hospital and Institute.
Recruitment status was:  Recruiting
First Posted : April 5, 2018
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Jinming Yu, Shandong Cancer Hospital and Institute

Brief Summary:
The purpose of this study is to determine whether chemotherapy combination with local radiotherapy and rhGM-CSF is safe, effective in the treatment of oligometastatic stage IV NSCLC patients.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Biological: rhGM-CSF Drug: Pemetrexed Radiation: Local Radiotherapy Drug: Single agent Not Applicable

Detailed Description:
The purpose of this study is to determine whether chemotherapy combination with local radiotherapy and recombined human granulocyte-macrophage colony stimulating factor(rhGM-CSF) is safe, effective in the treatment of oligometastatic stage IV NSCLC patients who were PR or SD after first-line chemotherapy,and to observe the abscopal effect, whether the scheme can improve PFS and OS.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Chemotherapy Combination With Local Radiotherapy and rhGM-CSF for Oligometastatic Stage IV NSCLC Patients Without Progression After First-line Chemotherapy: a Prospective Randomized Controlled Study
Actual Study Start Date : January 15, 2018
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: Radiotherapy+chemotherapy+ rhGM-CSF
Patients with PR or SD after first-line chemotherapy will be treated with pemetrexed on d1 (500mg/m2) or other single agent on d1, d8. Local radiotherapy dose will be> 4Gy per time(or BED >45Gy) from day 2 to day 15 in a cycle of 21 days. Subcutaneous injection of rhGM-CSF (200ug/m² per day) will be executed 24 hours after chemotherapy. Repeat in the second metastatic lesions.
Biological: rhGM-CSF
rhGM-CSF is a stimulator of the growth and differentiation of hematopoietic progenitor cells committed to neutrophils, monocytes or eosinophils. rhGM-CSF can promote the maturation of dendritic cells and macrophage, increase their antigen presentation ability.
Other Name: Recombinant human granulocyte macrophage stimulating factor

Drug: Pemetrexed
Pemetrexed (brand name Alimta) is a chemotherapy drug manufactured and marketed by Eli Lilly and Company. Its indications are the treatment of pleural mesothelioma and non-small cell lung cancer.

Radiation: Local Radiotherapy
Radiotherapy promotes the release of tumor antigen
Other Name: Local Radiation therapy

Drug: Single agent
Other chemotherapy drugs,such as Docetaxel, gemcitabine
Other Name: Single agent for maintenance therapy

Experimental: Single agent maintenance therapy
Maintenance treatment by single agent in a cycle of 21 days.
Drug: Single agent
Other chemotherapy drugs,such as Docetaxel, gemcitabine
Other Name: Single agent for maintenance therapy




Primary Outcome Measures :
  1. PFS [ Time Frame: 2 years ]
    Progression-Free-Survival


Secondary Outcome Measures :
  1. Abscopal effect rate [ Time Frame: At the time point of 4 weeks after completion of rhGM-CSF ]
    Radiotherapy-induced immune-mediated tumour regression at sites distant to the irradiated field

  2. OS [ Time Frame: 2 years ]
    Overall survival



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Stage IV NSCLC patients without clear driving genes who were PR or SD after standard first-line chemotherapy;
  2. Patients who were oligometastasis evaluated by PET-CT or other examinations after first-line chemotherapy. Eligible patients should have 2 to 5 distant metastases (at least 2 metastases were suitable for low fractionated radiotherapy). At least one distant measurable lesion outside the radiation sites.
  3. Age varied from 18 to 75 years old.
  4. ECOG performance status 0-2.
  5. Expected lifespan ≥3 months.
  6. Absolute neutrophil count (ANC) ≥1.5×109/L, Platelets ≥100×109/L, Hemoglobin ≥90 g/L.
  7. Able to understand and give written informed consent and comply with study procedures.

Exclusion criteria

  1. Allergy of rhGM-CSF and its accessories.
  2. Disease of systemic immune or immune disorders.
  3. Histology confirmed small cell carcinoma or other malignant compositions in the cancer tissue.
  4. Patients with thrombotic disease or platelets ≥600×109/L
  5. Cancer history within 5 years apart from NSCLC before enrollment.
  6. Tumor related immunotherapy within 4 weeks, including but not limited to immune cell therapy, tumor vaccine therapy, Immune checkpoint therapy, and other immunomodulators (such as thymosin, lentinan) except for rhGM-CSF.
  7. The abnormality of kidney , heart or lung functions(serum creatinine, Cr>177mol/L; serum AST or ALT more than 2 times above normal limits; total bilirubin, TBIL>34mol/L).
  8. HIV virus, hepatitis C virus or T lymphocyte virus (type1 or type 2) infection and active hepatitis or other uncontrolled infections.
  9. Women in pregnancy or lactation.
  10. Others who do not meet the inclusion criteria.

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): NCT03489616


Contacts
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Contact: Ming Huan Li, doctor 131 5303 5389 sy_lmh2001@163.com
Contact: JINMING YU, doctor 13806406293 ext 0531-87984729 jn7984729@public.jn.sd.cn

Locations
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China, Shandong
Shandong Cancer Hospital and Institute Recruiting
Jinan, Shandong, China, 250000
Contact: MINGHUAN LI, Doctor    13153035389 ext 0531-67626112    Sy_lmh2001@163.com   
Contact: JIMING YU, Doctor    13806406293 ext 0531-87984729    jn7984729@public.jn.sd.cn   
SHANDONG Cancer Hospital Recruiting
Jinan, Shandong, China, 250000
Sponsors and Collaborators
Shandong Cancer Hospital and Institute
Investigators
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Principal Investigator: JINMING YU, doctor Shandong Cancer Hospital and Institute
Publications of Results:
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Responsible Party: Jinming Yu, chief physician, Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier: NCT03489616    
Other Study ID Numbers: SDCH201701LC
First Posted: April 5, 2018    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors