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Omitting CTV for Primary Tumor in LS-SCLC
Sponsor: Sun Yat-sen University
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.
Official title: Omission of Clinical Target Volume (CTV) for Primary Tumors in Limited-Stage Small Cell Lung Cancer: A Prospective Multicenter Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
852
Start Date
2025-06-03
Completion Date
2032-12-31
Last Updated
2025-06-06
Healthy Volunteers
No
Interventions
Radiation Therapy
Twice-daily (45 Gy/30 fractions) or once-daily (45 Gy/15 fractions) thoracic radiotherapy after 2-4 cycles of chemotherapy
Etoposide + carboplatin; Etoposide + cisplatin
Carboplatin IV (AUC=5) on day 1 combined with etoposide IV (100mg/m2) on days 1-3, or cisplatin IV (25mg/m2) on days 1-3 combined with etoposide IV (100mg/m2) on days 1-3. Treatment is repeated every 21 days for 4-6 cycles.
Creating CTV for primary tumor
A margin of 0.8 cm beyond the gross target volume of primary tumor.
prophylactic cranial irradiation (PCI)
Beginning 4-6 weeks after chemoradiotherapy completion, patients in both arms who achieve a complete or partial response without brain metastasis receive PCI at 25 Gy/10 fractions or 26 Gy/13 fractions, delivered once daily (5 days per week).
Locations (2)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Zhejiang Provincial Cancer Hospital
Hangzhou, Zhejiang, China