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

Phase 3

• Conditions: Small-cell Lung Cancer
• Interventions: Radiation: prophylactic cranial irradiation

• Registration Number: NCT04535739
• Lead Sponsor: Chinese Academy of Medical Sciences

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.

Study Timeline

• Study Start: 2019-07-01
• Status Verified: 2019-10
• Study First Submitted: 2020-08-28
• Study First Submitted QC: 2020-08-28
• Last Update Submitted: 2020-08-28
• Study First Posted: 2020-09-02
• Last Update Posted: 2020-09-02
• Primary Completion: 2022-01-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 414

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.

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Exclusion Criteria

• Patients with brain or nervous system metastases;
• Presence of high grade radiation comorbidities;
• Patients who are pregnant or lactating

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PCI group	prophylactic cranial irradiation	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。
control group	prophylactic cranial irradiation	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。

Primary Outcome Measures

Name	Time	Method
overall survival	2 year	rate of patients survival in 2 years

Secondary Outcome Measures

Name	Time	Method
brain metastases rates	2 year	Cumulative incidence of brain metastases over 2 year
side effect	2 year	HLVT
progression-free survival	2 year	the rate of patients survival from the treatment to death or progress

Trial Locations

Locations (1)

Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China