RecruitingPhase 3NCT07008716

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


Sponsor

Sun Yat-sen University

Enrollment

852 participants

Start Date

Jun 3, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a modified radiation therapy approach for limited-stage small-cell lung cancer (SCLC) that omits a traditional safety margin (called the CTV) around the primary tumor. Researchers want to determine if this more targeted approach is just as effective while reducing side effects. **You may be eligible if...** - You are between 18 and 75 years old with a confirmed SCLC diagnosis - Your cancer is limited-stage (has not spread widely beyond the chest) - You are in good physical condition (KPS ≥ 80) with less than 10% weight loss in the past 6 months - Your cancer has not progressed after 2–4 cycles of standard chemotherapy (etoposide/carboplatin or etoposide/cisplatin) - Your blood counts and organ function meet required levels **You may NOT be eligible if...** - You have another cancer (unless it has been cured for at least 5 years) - You have uncontrolled heart disease or had a heart attack in the past 6 months - You have a history of serious psychiatric illness - You are pregnant or breastfeeding - You have poorly controlled diabetes or high blood pressure - You have lung inflammation (interstitial pneumonia) or active infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONRadiation Therapy

Twice-daily (45 Gy/30 fractions) or once-daily (45 Gy/15 fractions) thoracic radiotherapy after 2-4 cycles of chemotherapy

DRUGEtoposide + 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.

RADIATIONCreating CTV for primary tumor

A margin of 0.8 cm beyond the gross target volume of primary tumor.

RADIATIONprophylactic 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

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NCT07008716


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