This study for a single-center prospective phase II randomized controlled train to assess the efficacy and safety of Induction therapy on thymoma .Methods patients with thymoma (stage Ⅲ and stage Ⅳa) were treated with 2 cycles of (NAB)-paclitaxel plus Cisolation (Paclitaxel For Injection(Aalbumin Bound)125 mg/m2 Day 1 、Day8 ,Cisplatin 75 mg/m2 Day 1of each 3-week cycle)or CEP(cisplatin 50 mg/m2 Day 1, epirubicin 75 mg/m2 Day 1,cyclophosphamide 500 mg/m2 Day 1 of each 3-week cycle). Following chemotherapy to evaluate the patient for operation. Patients without undergo surgery will be continued to receive 2 cycles of Primary chemotherap.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
NAB-Paclitaxel will be administered as 125 mg/m2 IV infusion on Day 1 、Day8 of each 3-week cycle. Cisplatin will be administered as 75 mg/m2 IV infusion on Day 1 of each 3-week cycle. Patients will receive maximum of 4 cycles if they do not meet the criteria for removal from the study.
Cisplatin was administered as 50 mg/m2 IV infusion on Day 1; Epirubicin was administered as 75 mg/m2 IV infusion on Day 1; Cyclophosphamide was administered as 500 mg/m2IV infusion on Day 1 of each 3-week cycle.Patients will receive maximum of 4 cycles if they do not meet the criteria for removal from the study.
Yian Zhang
Shanghai, Shanghai Municipality, China
overall response rate (ORR)
the proportion of patients with complete response and partial response , using RECIST v 1.1
Time frame: assessed up to 1 year
3-year disease free survival (3yr-DFS)
the percentage of Primary thymoma patients without recurrence/metastasis within 3 years in all enrolled patients
Time frame: assessed up to 3 year
overall survival rate (OS)
from date of enrolment to date of death of any reason
Time frame: assessed up to 3 year
Incidence of adverse events
Time frame: assessed up to 1 year
Surgical conversion success rate
Following chemotherapy to evaluate proportion of patients underwent timely operation
Time frame: assessed up to 1 year
Pathologic Complete Response(pCR)
the proportion of patients with complete response , using RECIST v 1.1
Time frame: assessed up to 1 year
Main pathological Response
the proportion of patients with complete response and partial response , using RECIST v 1.1
Time frame: assessed up to 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.