Omitting CTV for Primary Tumor in LS-SCLC

NCT07008716 | Recruiting Phase 3 DMC

• 1 other identifier: B2022-792
• Study Type: interventional
• Target: 852
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• Local progression free survival

  From the date chemotherapy commenced to the first clinical or radiological evidence of progressive disease at the primary site or death, whichever occurs first, to be assessed up to 3 years

• Severe toxicity free survival

  From the date chemotherapy commenced to the first record of serious adverse events related to radiotherapy, to be assessed up to 3 years

Secondary Outcomes (4)

• Overall survival

  From the date chemotherapy commenced to the date of death from any cause or the end of follow-up at 3 years

• Progression free survival

  From the date chemotherapy commenced to disease progression or death, whichever occurs first, to be assessed up to 3 years

• Number of participants with recurrence or metastasis as evaluated by RECIST 1.1

  From the date chemotherapy commenced to the end of follow-up at 3 years

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  From the date chemotherapy commenced to the end of follow-up at 3 years

Study Arms (2)

Control group

ACTIVE COMPARATOR

Creating CTV for primary tumor.

Radiation: Radiation Therapy; Drug: Etoposide + carboplatin; Etoposide + cisplatin; Radiation: Creating CTV for primary tumor; Radiation: prophylactic cranial irradiation (PCI)

Experimental group

EXPERIMENTAL

Omitting CTV for primary tumor.

Radiation: Radiation Therapy; Drug: Etoposide + carboplatin; Etoposide + cisplatin; Radiation: prophylactic cranial irradiation (PCI)

Interventions

Radiation Therapy RADIATION

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

Control group; Experimental group

Etoposide + carboplatin; Etoposide + cisplatin 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.

Control group; Experimental group

Creating CTV for primary tumor RADIATION

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

Control group

prophylactic cranial irradiation (PCI) 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).

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Small cell lung cancer confirmed by histology or cytology; TNM stage IA-IIIC (AJCC 8th edition, 2017; limited-stage) without intrapulmonary metastasis;
• Aged 18-75 years, KPS score ≥ 80, ≤ 10% weight loss within the past 6 months;
• Have measurable lesions per RECIST 1.1 criteria;
• Have no disease progression after 2-4 cycles of etoposide/carboplatin or etoposide/cisplatin;
• Lung function test: FEV1 ≥ 1 L (Optional);
• Complete blood count: neutrophil count ≥ 1.5 x 10\^9/L, hemoglobin ≥ 100 g/L, platelet count ≥ 100 x 10\^9/L;
• Renal function: serum creatinine ≤ 1.5 x upper limit of normal (ULN);
• Liver function: AST and ALT ≤ 2.5 x ULN, bilirubin ≤ 1.5 x ULN;
• Fully understand the study, able to complete treatment and follow-up, and voluntarily sign the informed consent.

You may not qualify if:

• 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;
• Uncontrolled heart disease or myocardial infarction within the past 6 months;
• Patients with a history of mental illness;
• Pregnant and lactating patients;
• Poorly controlled diabetes and hypertension;
• Interstitial pneumonia or active pulmonary fibrosis;
• Active infection;
• Other conditions unsuitable for enrollment (per investigator judgment).

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (2)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Zhejiang Provincial Cancer Hospital

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Radiation Injuries; Disease Progression

Interventions

Radiotherapy; Etoposide; Carboplatin; Cisplatin

Condition Hierarchy (Ancestors)

Wounds and Injuries; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Coordination Complexes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Ming Chen

CONTACT

86+02087343504; chenming@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: June 6, 2025
• Study Start: June 3, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2032
• Last Updated: June 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)