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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

Tracking Information
First Submitted Date  ICMJE March 29, 2018
First Posted Date  ICMJE April 5, 2018
Last Update Posted Date April 5, 2018
Actual Study Start Date  ICMJE January 15, 2018
Estimated Primary Completion Date July 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2018)
PFS [ Time Frame: 2 years ]
Progression-Free-Survival
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2018)
  • 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
  • OS [ Time Frame: 2 years ]
    Overall survival
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Chemotherapy Combination With Local Radiotherapy and rhGM-CSF for Oligometastatic Stage IV NSCLC Patients
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Biological: rhGM-CSF
    • Drug: Pemetrexed
    • Radiation: Local Radiotherapy
    • Drug: Single agent
  • Experimental: Single agent maintenance therapy
    Maintenance treatment by single agent in a cycle of 21 days.
    Intervention: Drug: Single agent
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 4, 2018)
45
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date July 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03489616
Other Study ID Numbers  ICMJE SDCH201701LC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Jinming Yu, Shandong Cancer Hospital and Institute
Study Sponsor  ICMJE Shandong Cancer Hospital and Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: JINMING YU, doctor Shandong Cancer Hospital and Institute
PRS Account Shandong Cancer Hospital and Institute
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP