Actively Recruiting
Omission of Clinical Target Volume (CTV) for Primary Tumors in Limited-Stage Small Cell Lung Cancer: A Prospective Multicenter Randomized Controlled Trial
Led by Sun Yat-sen University · Updated on 2025-06-06
852
Participants Needed
2
Research Sites
261 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating a new approach to radiotherapy for patients with limited-stage small cell lung cancer (LS-SCLC). This randomized controlled trial compares standard radiotherapy that includes the clinical target volume (CTV) for the primary tumor with a treatment that omits the CTV. The goal is to see if reducing the target volume can maintain cancer control while lowering radiation exposure to healthy organs and reducing side effects. Participants receive chemotherapy with either etoposide combined with carboplatin or cisplatin for 4 to 6 cycles. After 2 to 4 cycles, they undergo thoracic radiotherapy, given either twice daily or once daily, depending on the group. The control group receives radiotherapy including a 0.8 cm margin around the tumor (CTV), while the experimental group omits this margin. Patients who respond to treatment without brain metastasis may then receive prophylactic cranial irradiation (PCI) starting 4 to 6 weeks after chemoradiotherapy. Throughout the study, participants are monitored for local progression-free survival and severe toxicity-free survival up to three years from the start of chemotherapy. Other assessments include overall survival, progression-free survival, tumor recurrence or metastasis, and treatment-related side effects. The study tracks these outcomes through clinical and radiological evaluations to understand the balance of effectiveness and safety between the two radiotherapy approaches.
CONDITIONS
Brief 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 (limited-stage) without intrapulmonary metastasis
- Aged 18 to 75 years
- Karnofsky Performance Status (KPS) score 80 or higher
- Weight loss less than or equal to 10% in the past 6 months
- Measurable lesions based on RECIST 1.1 criteria
- No disease progression after 2 to 4 cycles of etoposide combined with carboplatin or cisplatin chemotherapy
- Optional lung function test with FEV1 of 1 liter or more
- Blood counts within specified limits: neutrophils ≥ 1.5 x 10^9/L, hemoglobin ≥ 100 g/L, platelets ≥ 100 x 10^9/L
- Kidney function with serum creatinine ≤ 1.5 times the upper limit of normal
- Liver function with AST and ALT ≤ 2.5 times the upper limit of normal, bilirubin ≤ 1.5 times the upper limit of normal
- Ability to understand the study, complete treatment and follow-up, and provide informed consent
You will not qualify if you...
- Other cancers except those cured with disease-free survival of 5 years or more (e.g., non-melanoma skin cancer, cervical carcinoma in situ, early-stage papillary thyroid cancer)
- Uncontrolled heart disease or heart attack within the last 6 months
- History of mental illness
- Pregnant or breastfeeding
- Poorly controlled diabetes or high blood pressure
- Interstitial pneumonia or active lung fibrosis
- Active infections
- Any other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 12 to 18 weeks depending on chemotherapy cycles and radiotherapy schedule
Participants receive 4 to 6 cycles of chemotherapy with etoposide combined with carboplatin or cisplatin, followed by thoracic radiotherapy with either twice-daily or once-daily sessions. Radiation therapy may include creating or omitting a clinical target volume (CTV) for the primary tumor depending on the assigned group.
Multiple visits for chemotherapy and radiotherapy sessions over several weeks
Duration - Up to 3 years
Participants who achieve a complete or partial response without brain metastasis may receive prophylactic cranial irradiation (PCI) starting 4 to 6 weeks after chemoradiotherapy completion. Participants are then monitored for treatment outcomes and adverse events for up to 3 years.
Regular follow-up visits for monitoring and assessments
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
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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