Small-cell Lung Cancer
Conditions
Keywords
small cell lung cancer, Brain Metastases
Brief summary
prophylactic cranial irradiation （PCI）was verified to decrease the brain metastases rates and improve the overall survival（OS）for patients with limited stage small cell lung cancer.We hypothesis that patients with extensive-stage small cell lung cancer after chemotherapy and thoracic radiation can also benefit from PCI.
Detailed description
Patients with extensive-stage small cell lung cancer achieving CR or PR after chemotherapy and thoracic radiation therapy were randomly divided into observation group and prophylactic cranial irradiation (PCI) group to evaluate the effect of PCI on survival after radiation therapy for thoracic lesions. To preliminarily analyze the clinical characteristics of patients who would benefit from thoracic radiation therapy plus PCI. To explore the optimal treatment modality after chemotherapy + thoracic radiation therapy in patients with extensive-stage SCLC.
Interventions
RADIATIONprophylactic cranial irradiation
25Gy/2.5Gy/10f were given for PCI patients
Sponsors
Chinese Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 18-65 years old,KPS≥70 * Pathological or cytological diagnosis of stage IV small cell lung cancer (by using AJCC 7th edition staging criteria); * 1-3 extra-cranial metastatic organs before chemotherapy; 4-6 cycles of CE or EP ； * CR or PR after chemotherapy； * no grade ≥II side effects; * the estimated overall survival time ≥ 3 months; * no serious medical disease or major organ dysfunction.
Exclusion criteria
* Patients with brain or nervous system metastases; * Presence of high grade radiation comorbidities; * Patients who are pregnant or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | 2 year | rate of patients survival in 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| progression-free survival | 2 year | the rate of patients survival from the treatment to death or progress |
| brain metastases rates | 2 year | Cumulative incidence of brain metastases over 2 year |
| side effect | 2 year | HLVT |
Countries
China
Contacts
Primary Contactzongmei zhou, master
Backup Contactlei deng, dr
Outcome results
None listed