Omitting CTV for Primary Tumor in LS-SCLC

Launched by SUN YAT-SEN UNIVERSITY · May 29, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat patients with limited-stage small cell lung cancer (LS-SCLC). The researchers want to find out if they can safely skip a part of the radiation treatment called the clinical target volume (CTV) for the primary tumor. This approach could help reduce side effects by lowering the radiation dose to nearby healthy organs without increasing the chances of the cancer coming back. The trial is comparing two groups: one that receives the standard treatment with CTV included and another that has the CTV omitted.

To participate, patients must be between 18 and 75 years old, have a confirmed diagnosis of LS-SCLC, and meet certain health criteria, like having good lung function and stable overall health. Participants can expect to receive either the standard radiation treatment or the new approach and will be closely monitored for how well the treatment works and any side effects they may experience. It’s important for potential participants to understand the study and be willing to commit to the treatment and follow-ups, as well as to provide informed consent before joining.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Small cell lung cancer confirmed by histology or cytology; TNM stage IA-IIIC (AJCC 8th edition, 2017; limited-stage) without intrapulmonary metastasis;
• • 2. Aged 18-75 years, KPS score ≥ 80, ≤ 10% weight loss within the past 6 months;
• • 3. Have measurable lesions per RECIST 1.1 criteria;
• • 4. Have no disease progression after 2-4 cycles of etoposide/carboplatin or etoposide/cisplatin;
• • 5. Lung function test: FEV1 ≥ 1 L (Optional);
• • 6. Complete blood count: neutrophil count ≥ 1.5 x 10\^9/L, hemoglobin ≥ 100 g/L, platelet count ≥ 100 x 10\^9/L;
• • 7. Renal function: serum creatinine ≤ 1.5 x upper limit of normal (ULN);
• • 8. Liver function: AST and ALT ≤ 2.5 x ULN, bilirubin ≤ 1.5 x ULN;
• • 9. Fully understand the study, able to complete treatment and follow-up, and voluntarily sign the informed consent.
• Exclusion Criteria:
• • 1. Other malignant tumors (prior or concurrent), except those that have been curatively treated with disease-free survival ≥ 5 years, such as non-melanoma skin cancer, cervical carcinoma in situ, or early-stage papillary thyroid cancer;
• • 2. Uncontrolled heart disease or myocardial infarction within the past 6 months;
• • 3. Patients with a history of mental illness;
• • 4. Pregnant and lactating patients;
• • 5. Poorly controlled diabetes and hypertension;
• • 6. Interstitial pneumonia or active pulmonary fibrosis;
• • 7. Active infection;
• • 8. Other conditions unsuitable for enrollment (per investigator judgment).