Omitting CTV for Primary Tumor in LS-SCLC (NCT07008716) | Clinical Trial Compass
RecruitingPhase 3
Omitting CTV for Primary Tumor in LS-SCLC
China852 participantsStarted 2025-06-03
Plain-language summary
This randomized controlled non-inferior trial prospectively enrolled patients with limited-stage small cell lung cancer (LS-SCLC). Patients in the experimental group would receive radiotherapy with omission of the clinical target volume (CTV) for the primary tumor, while those in the control group would receive radiotherapy including CTV. The efficacy and toxicity of the two groups are compared to provide evidence for the radiotherapy of LS-SCLC. The target volume of LS-SCLC may be reduced by omitting CTV without increasing local recurrence but potentially reducing the dose to organs at risk and the side effects.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Small cell lung cancer confirmed by histology or cytology; TNM stage IA-IIIC (AJCC 8th edition, 2017; limited-stage) without intrapulmonary metastasis;
✓. Aged 18-75 years, KPS score ≥ 80, ≤ 10% weight loss within the past 6 months;
✓. Have measurable lesions per RECIST 1.1 criteria;
✓. Have no disease progression after 2-4 cycles of etoposide/carboplatin or etoposide/cisplatin;
✓. Lung function test: FEV1 ≥ 1 L (Optional);
✓. Complete blood count: neutrophil count ≥ 1.5 x 10\^9/L, hemoglobin ≥ 100 g/L, platelet count ≥ 100 x 10\^9/L;
✓. Renal function: serum creatinine ≤ 1.5 x upper limit of normal (ULN);
✓. Liver function: AST and ALT ≤ 2.5 x ULN, bilirubin ≤ 1.5 x ULN;
Exclusion criteria
✕. 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;
What they're measuring
1
Local progression free survival
Timeframe: From the date chemotherapy commenced to the first clinical or radiological evidence of progressive disease at the primary site or death, whichever occurs first, to be assessed up to 3 years
2
Severe toxicity free survival
Timeframe: From the date chemotherapy commenced to the first record of serious adverse events related to radiotherapy, to be assessed up to 3 years