Clinical trial NCT07008716: Omitting CTV for Primary Tumor in LS-SCLC
Official title: Omission of Clinical Target Volume (CTV) for Primary Tumors in Limited-Stage Small Cell Lung Cancer: A Prospective Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: SCLC, Limited Stage
Radiation Exposure
Radiotherapy Side Effect
Progression
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 852
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Local progression free survival
timeFrame: 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
measure: Severe toxicity free survival
timeFrame: 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:
measure: Overall survival
timeFrame: From the date chemotherapy commenced to the date of death from any cause or the end of follow-up at 3 years
measure: Progression free survival
timeFrame: From the date chemotherapy commenced to disease progression or death, whichever occurs first, to be assessed up to 3 years
measure: Number of participants with recurrence or metastasis as evaluated by RECIST 1.1
timeFrame: From the date chemotherapy commenced to the end of follow-up at 3 years
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: From the date chemotherapy commenced to the end of follow-up at 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Hangzhou
country: China
facility: Zhejiang Provincial Cancer Hospital
state: Zhejiang
Study officials:
References: