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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

A prospective randomized controlled study for prophylactic cranial irradiation after chemotherapy and thoracic radiation therapy in patients with extensive-stage small cell lung cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900024021
Enrollment
Unknown
Registered
2019-06-22
Start date
2019-07-01
Completion date
Unknown
Last updated
2019-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

extensive-stage small cell lung cancer

Interventions

PCI group:prophylactic cranial irradiation
control group:none

Sponsors

Cancer Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 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; Chemotherapy with CE (etoposide + carboplatin) or EP (etoposide + cisplatin) regimen for 4 ~ 6 cycles, and patients with complete remission or partial remission (more than 1 site) after chemotherapy; There was no progression of tumor lesions after chemotherapy; There was no abnormality of degree II or above in blood indicators after chemotherapy (including blood routine and liver and kidney function, according to CTCAE 4.0 criteria); Aged from 18 to 65 years, kps score = 70; They agree to participate in the study and may independently sign the informed consent form; the estimated survival time = 3 months; There was no serious medical disease or major organ dysfunction.

Exclusion criteria

Exclusion criteria: Patients with brain or nervous system metastases; Presence of serious or acute comorbidities; Patients who are pregnant or lactating.

Design outcomes

Primary

MeasureTime frame
2 year overall survival;

Secondary

MeasureTime frame
Cumulative incidence of brain metastases over 2 years;2 years of progression-free survival;score of Hopkins Verbal Learning Test;side effects of treatment;failure type;Exploratory biomarker analysis (detection of CTC, ctDNA and microRNA);

Countries

China

Contacts

Public ContactZhou Zongmei

Cancer Hospital, Chinese Academy of Medical Sciences

zhouzongmei2013@163.com+86 010-87787643

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026