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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
852
Twice-daily (45 Gy/30 fractions) or once-daily (45 Gy/15 fractions) thoracic radiotherapy after 2-4 cycles of chemotherapy
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.
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).
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGZhejiang Provincial Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGLocal progression free survival
Time frame: 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
Time frame: From the date chemotherapy commenced to the first record of serious adverse events related to radiotherapy, to be assessed up to 3 years
Overall survival
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From the date chemotherapy commenced to the end of follow-up at 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.