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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 3

Conditions: Small-cell Lung Cancer

Treatments: Radiation: prophylactic cranial irradiation

Study type: Interventional

Funder types: Other

Identifiers

NCT04535739

17-184/1440

Details and patient eligibility

About

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.

Full 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.

Enrollment: 414 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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414 participants in 2 patient groups

PCI group

Experimental group

Description:

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。

Treatment:

Radiation: prophylactic cranial irradiation

control group

Other group

Description:

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。

Treatment:

Radiation: prophylactic cranial irradiation