Omission of Clinical Target Volume (CTV) for Primary Tumors in Limited-Stage Small Cell Lung Cancer: A Prospective Multicenter Randomized Controlled Trial
| Registry | NCT07008716 |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 852 (Estimated) |
| Sponsor | Sun Yat-sen University (Other) |
| Conditions | SCLC, Limited Stage, Radiation Exposure, Radiotherapy Side Effect, Progression |
| Interventions | Radiation Therapy, Etoposide + carboplatin; Etoposide + cisplatin, Creating CTV for primary tumor, prophylactic cranial irradiation (PCI) (Radiation, drug) |
| Dates | start 2025-06-03 (estimated), primary completion 2027-12-31 (estimated), completion 2032-12-31 (estimated), first posted 2025-06-06, last updated 2025-06-06 |
| Locations | 2 sites in China |
Related Papers Related Patents Related Grants Related Experts
All trials for SCLC, Limited Stage All trials for Radiation Exposure All trials of Radiation Therapy All trials of Etoposide + carboplatin; Etoposide + cisplatin
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Control group | Active comparator | Radiation: Radiation Therapy; Drug: Etoposide + carboplatin; Etoposide + cisplatin; Radiation: Creating CTV for primary tumor; Radiation: prophylactic cranial irradiation (PCI) | Creating CTV for primary tumor. |
| Experimental group | Experimental | Radiation: Radiation Therapy; Drug: Etoposide + carboplatin; Etoposide + cisplatin; Radiation: prophylactic cranial irradiation (PCI) | Omitting CTV for primary tumor. |
Sex: All, ages: 18 Years to 75 Years
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).
| Facility | City | Country | Status |
|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou, Guangdong | China | Recruiting |
| Zhejiang Provincial Cancer Hospital | Hangzhou, Zhejiang | China | Recruiting |