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Online adaptive radiotherapy for limited stage small cell lung cancer: a single-arm phase II trial

Online adaptive radiotherapy for limited stage small cell lung cancer: a single-arm phase II trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067831
Enrollment
Unknown
Registered
2023-01-28
Start date
2023-01-28
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Small cell lung cancer

Interventions

treatment group:Online adaptive radiotherapy

Sponsors

Sun Yat-sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Small cell carcinoma confirmed by histology or cytology; 2. Aged 18-75 years, KPS score >= 70; 3. Limited stage; excluded malignant pleural effusion confirmed by cytology or clinical judgment, and the pleural effusion on chest CT was less than 1cm thick (no intrapulmonary metastasis at the IA-IIIC stage in the 8th AJCC stage in 2017); 4. Have measurable lesions that meet RECIST v1.1 criteria for evaluation; 5. EP/EC chemotherapy = 1 L; 7. Blood routine: neutrophil count >= 1.5 x 10^9/L, hemoglobin >= 100 g/L, platelet count >=100 x 10^9/L; 8. Renal function: serum creatinine <= 1.5 times the upper limit of normal; 9. Liver function: AST and ALT <= 2.5 times the upper limit of normal, bilirubin <= 1.5 times the upper limit of normal; 10. Fully understand the study, able to complete treatment and follow-up, and voluntarily sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Other malignant tumors within 5 years, excluding non-melanoma skin cancer and carcinoma in situ; 2. Uncontrolled heart disease or myocardial infarction within last 6 months; 3. Uncontrolled diabetes and hypertension; 4. Interstitial pneumonia or active pulmonary fibrosis; 5. Active infection; 6. Patients with a history of mental illness; 7. Pregnant and lactating patients; 8. Other conditions that the investigator believes not suitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Patterns of treatment failure;Progression-free survival;

Secondary

MeasureTime frame
Overall survival;Incidence and severity of adverse events;

Countries

China

Contacts

Public ContactMing Chen

Sun Yat-sen University Cancer Center

chenming@sysucc.org.cn+86 18758875572

Outcome results

None listed

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