Skipping the clinical target volume (CTV) around the primary tumor in limited-stage small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized phase 3 non-inferiority trial comparing two radiation approaches for limited-stage small cell lung cancer after 2–4 cycles of etoposide with cisplatin or carboplatin. One arm receives radiotherapy that omits the clinical target volume (CTV) for the primary tumor, while the control arm receives standard radiotherapy including CTV; both arms may include prophylactic cranial irradiation as indicated. The trial compares local control, progression, survival outcomes, and treatment-related toxicity between the groups. The aim is to see if smaller target volumes can maintain tumor control while reducing dose to nearby organs and treatment side effects.

Why it matters

Who can join: the full rules

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).

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting
• Zhejiang Provincial Cancer Hospital
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Ming Chen
• Email: chenming@sysucc.org.cn
• Phone: 86+02087343504

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.