NCT07008716

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 852 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• SCLC, Limited Stage
• Radiation Exposure
• Radiotherapy Side Effect
• Progression

Interventions

Type	Name	Description
RADIATION	Radiation Therapy	Twice-daily (45 Gy/30 fractions) or once-daily (45 Gy/15 fractions) thoracic radiotherapy after 2-4 cycles of chemotherapy
DRUG	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.
RADIATION	Creating CTV for primary tumor	A margin of 0.8 cm beyond the gross target volume of primary tumor.
RADIATION	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).

Timeline

• Start date: 2025-06-03
• Primary completion: 2027-12-31
• Completion: 2032-12-31
• First posted: 2025-06-06
• Last updated: 2025-06-06

Locations

2 sites across 1 country: China