NCT07008716RecruitingPhase 3
Omitting CTV for Primary Tumor in LS-SCLC
Omission of Clinical Target Volume (CTV) for Primary Tumors in Limited-Stage Small Cell Lung Cancer: A Prospective Multicenter Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 6 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 852 (estimated)
- First submitted
- 19 May 2025
- Start date
- 3 Jun 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Lung cancer
- NCT number
- NCT07008716
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 852
- From 3 Jun 2025 to the primary completion date, 31 Dec 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- Uncontrolled heart disease or myocardial infarction within the past 6 months;
- Patients with a history of mental illness;
- Poorly controlled diabetes and hypertension;
- Active infection;
- Other conditions unsuitable for enrollment (per investigator judgment).
Other
- Pregnant and lactating patients;
- Interstitial pneumonia or active pulmonary fibrosis;
Who the study is looking for
- 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;
- Fully understand the study, able to complete treatment and follow-up, and voluntarily sign the informed consent.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Zhejiang Provincial Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.