Omitting CTV for Primary Tumor in LS-SCLC

NCT ID: NCT07008716

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 852 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-03
• Study Completion Date: 2032-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

Creating CTV for primary tumor.

Group Type: ACTIVE_COMPARATOR

Radiation Therapy

Intervention Type: RADIATION

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

Intervention Type: DRUG

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

Intervention Type: RADIATION

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

prophylactic cranial irradiation (PCI)

Intervention Type: RADIATION

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).

Experimental group

Omitting CTV for primary tumor.

Group Type: EXPERIMENTAL

Radiation Therapy

Intervention Type: RADIATION

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

Intervention Type: DRUG

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.

prophylactic cranial irradiation (PCI)

Intervention Type: RADIATION

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).

Interventions

Radiation Therapy

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

Intervention Type: RADIATION

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.

Intervention Type: DRUG

Creating CTV for primary tumor

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

Intervention Type: 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).

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

1. Small cell lung cancer confirmed by histology or cytology; TNM stage IA-IIIC (AJCC 8th edition, 2017; limited-stage) without intrapulmonary metastasis;

2. Aged 18-75 years, KPS score ≥ 80, ≤ 10% weight loss within the past 6 months;

3. Have measurable lesions per RECIST 1.1 criteria;

4. Have no disease progression after 2-4 cycles of etoposide/carboplatin or etoposide/cisplatin;

5. Lung function test: FEV1 ≥ 1 L (Optional);

6. Complete blood count: neutrophil count ≥ 1.5 x 10^9/L, hemoglobin ≥ 100 g/L, platelet count ≥ 100 x 10^9/L;

7. Renal function: serum creatinine ≤ 1.5 x upper limit of normal (ULN);

8. Liver function: AST and ALT ≤ 2.5 x ULN, bilirubin ≤ 1.5 x ULN;

9. Fully understand the study, able to complete treatment and follow-up, and voluntarily sign the informed consent.

Exclusion Criteria

1. Other malignant tumors (prior or concurrent), except those that have been curatively treated with disease-free survival ≥ 5 years, such as non-melanoma skin cancer, cervical carcinoma in situ, or early-stage papillary thyroid cancer;

2. Uncontrolled heart disease or myocardial infarction within the past 6 months;

3. Patients with a history of mental illness;

4. Pregnant and lactating patients;

5. Poorly controlled diabetes and hypertension;

6. Interstitial pneumonia or active pulmonary fibrosis;

7. Active infection;

8. Other conditions unsuitable for enrollment (per investigator judgment).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Shuohan Zheng

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Zhejiang Provincial Cancer Hospital

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ming Chen

Role: CONTACT

chenming@sysucc.org.cn

86+02087343504

Facility Contacts

Ming Chen

Role: primary

Xiao Hu

Role: primary

Other Identifiers

B2022-792

Identifier Type: -

Identifier Source: org_study_id