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
Overview
- Phase
- Not Applicable
- Intervention
- rhGM-CSF
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Sponsor
- Shandong Cancer Hospital and Institute
- Enrollment
- 45
- Locations
- 2
- Primary Endpoint
- PFS
- Last Updated
- 8 years ago
Overview
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.
Investigators
Jinming Yu
chief physician
Shandong Cancer Hospital and Institute
Eligibility Criteria
Inclusion Criteria
- •Stage IV NSCLC patients without clear driving genes who were PR or SD after standard first-line chemotherapy;
- •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.
- •Age varied from 18 to 75 years old.
- •ECOG performance status 0-
- •Expected lifespan ≥3 months.
- •Absolute neutrophil count (ANC) ≥1.5×109/L, Platelets ≥100×109/L, Hemoglobin ≥90 g/L.
- •Able to understand and give written informed consent and comply with study procedures.
- •Exclusion criteria
- •Allergy of rhGM-CSF and its accessories.
- •Disease of systemic immune or immune disorders.
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: rhGM-CSF
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.
Intervention: Pemetrexed
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.
Intervention: Local Radiotherapy
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.
Intervention: Single agent
Single agent maintenance therapy
Maintenance treatment by single agent in a cycle of 21 days.
Intervention: Single agent
Outcomes
Primary Outcomes
PFS
Time Frame: 2 years
Progression-Free-Survival
Secondary Outcomes
- Abscopal effect rate(At the time point of 4 weeks after completion of rhGM-CSF)
- OS(2 years)