PCI for Patients With ES-SCLC After RCT:a Prospective Randomized Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Randomized Controlled Study for Prophylactic Cranial Irradiation After Chemotherapy and Thoracic Radiation Therapy in Patients With Extensive-stage Small Cell Lung Cancer

Conditions
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Small-cell Lung Cancer

Intervention / Treatment
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* Radiation: prophylactic cranial irradiation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PCI group<br>patients received 4-6 circles of chemotherapy of EP or EC，and patients with complete remission or partial remission (more than 1 site) after chemotherapy，patients received thoracic radiotherapy and prophylactic cranial irradiation。 | Radiation: prophylactic cranial irradiation<br>* 25Gy/2.5Gy/10f were given for PCI patients<br>|
| Other: control group<br>patients received 4-6 circles of chemotherapy of EP or EC，and patients with complete remission or partial remission (more than 1 site) after chemotherapy，patients received thoracic radiotherapy。 | Radiation: prophylactic cranial irradiation<br>* 25Gy/2.5Gy/10f were given for PCI patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | rate of patients survival in 2 years | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival | the rate of patients survival from the treatment to death or progress | 2 year | 
| brain metastases rates | Cumulative incidence of brain metastases over 2 year | 2 year | 
| side effect | HLVT | 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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small cell lung cancer, Brain Metastases