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RECRUITING
NCT07008716
PHASE3

Omitting CTV for Primary Tumor in LS-SCLC

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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

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).

Locations (2)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Zhejiang Provincial Cancer Hospital

Hangzhou, Zhejiang, China