Actively Recruiting
Omitting CTV for Primary Tumor in LS-SCLC
Led by Sun Yat-sen University · Updated on 2025-06-06
852
Participants Needed
2
Research Sites
395 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Omitting CTV for Primary Tumor in LS-SCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 64 80, 64 10% weight loss within the past 6 months
- Measurable lesions per RECIST 1.1 criteria
- No disease progression after 2-4 cycles of etoposide/carboplatin or etoposide/cisplatin
- Lung function test: FEV1 64 1 L (optional)
- Complete blood count: neutrophil count 64 1.5 x 10^9/L, hemoglobin 64 100 g/L, platelet count 64 100 x 10^9/L
- Renal function: serum creatinine 64 1.5 x upper limit of normal (ULN)
- Liver function: AST and ALT 64 2.5 x ULN, bilirubin 64 1.5 x ULN
- Fully understand the study, able to complete treatment and follow-up, and voluntarily sign the informed consent
You will not qualify if you...
- Other malignant tumors (prior or concurrent), except those curatively treated with disease-free survival 64 5 years, such as non-melanoma skin cancer, cervical carcinoma in situ, or early-stage papillary thyroid cancer
- Uncontrolled heart disease or myocardial infarction within the past 6 months
- History of mental illness
- Pregnant and lactating patients
- Poorly controlled diabetes and hypertension
- Interstitial pneumonia or active pulmonary fibrosis
- Active infection
- Other conditions unsuitable for enrollment (per investigator judgment)
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
2
Zhejiang Provincial Cancer Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
M
Ming Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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