SCLC, Limited Stage, Radiation Exposure, Radiotherapy Side Effect, Progression
Conditions
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.
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.
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).
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Contacts
Primary ContactMing Chen
Outcome results
None listed