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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CEP | Active Comparator | 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. |
|
| NAB-Paclitaxel | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NAB-Paclitaxel plus Cisplatin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| overall response rate (ORR) | the proportion of patients with complete response and partial response , using RECIST v 1.1 | assessed up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year disease free survival (3yr-DFS) | the percentage of Primary thymoma patients without recurrence/metastasis within 3 years in all enrolled patients | assessed up to 3 year |
| overall survival rate (OS) |
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Inclusion Criteria:
18-75 years;
Histological or cytological confirmed stage Ⅲ and Ⅳa thymoma;
PET/CT or CT/MRI with at least one objectively measurable or evaluable lesion;
Life expectancy >12months;
ECOG PS 0-1;
--Patients with thymoma metastasis;
No found the other malignant tumors (expect has been controlled Carcinoma in situ of the cervix and Basal Cell Carcinoma);
Informed consent was signed before the study began;
Normal Bone marrow hematopoiesis and renal function,Blood routine: absolute neutrophil count≥1,500/uL,Hb>8.0g/dL,PLT>80×10*9/L,AST≤ 1.5 times the upper limit of normal,TBIL ≤1.5 times the upper limit of normal,calculated creatinine clearance ≤110µmol/L,blood urea nitrogen≤7.1mmol/L;
Cardiac function: LVEF≥55%;
Patients who have not active bleeding or coagulopathy before enrollment;
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bei Xu, Ph.D | Contact | 13817687547 | xu.bei2@zs-hospital.sh.cn | |
| Yue Fan, Ph.D | Contact | 13901874150 | fan.yue@zs-hospital.sh.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yian Zhang | Shanghai | Shanghai Municipality | 200032 | China |
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|
| Cisplatin plus Epirubicin plus Cyclophosphamide | Drug | 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. |
|
from date of enrolment to date of death of any reason
| assessed up to 3 year |
| Incidence of adverse events | assessed up to 1 year |
| Surgical conversion success rate | Following chemotherapy to evaluate proportion of patients underwent timely operation | assessed up to 1 year |
| Pathologic Complete Response(pCR) | the proportion of patients with complete response , using RECIST v 1.1 | assessed up to 1 year |
| Main pathological Response | the proportion of patients with complete response and partial response , using RECIST v 1.1 | assessed up to 1 year |
| ID | Term |
|---|---|
| D013945 | Thymoma |
| ID | Term |
|---|---|
| D018193 | Neoplasms, Complex and Mixed |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D013953 | Thymus Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
| D002945 | Cisplatin |
| D015251 | Epirubicin |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D004317 | Doxorubicin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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