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

Small-cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04535739
• Other study ID #: 17-184/1440
• Status: Recruiting
• Phase: Phase 3
• Start date: July 1, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: October 2019
• Source: Chinese Academy of Medical Sciences
• Contact: zongmei zhou, master
• Phone: 86 13801389769
• Email: zhouzongmei2013[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 414
• Est. completion date: June 30, 2022
• Est. primary completion date: January 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Carcinoma
• Small-cell Lung Cancer

Intervention

Radiation:
• prophylactic cranial irradiation
25Gy/2.5Gy/10f were given for PCI patients

Locations

Country	Name	City	State
China	Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival	rate of patients survival in 2 years	2 year
Secondary	progression-free survival	the rate of patients survival from the treatment to death or progress	2 year
Secondary	brain metastases rates	Cumulative incidence of brain metastases over 2 year	2 year
Secondary	side effect	HLVT	2 year