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This is a prospective, multicenter, open label Phase II Clinical Trial. 30 advanced poorly differentiated thyroid carcinoma patients who were histopathologically confirmed inoperable were enrolled in this study.
Subjects will receive the treatment regimen as follow:
intravenous infusion of liposomal doxorubicin 35 mg/m2, d1; cisplatin 75 mg/m2, drip, total dose should be carried out on d1-3; once every 21days, for 6 cycles. Stop the treatment if the patients have progressed or intolerated to the toxicity. The primary endpoint is disease control rate(DCR), the secondary endpoint is overall survival (OS), progression-free survival (PFS), safety and quality of life assessment(QoL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PLD plus Cisplatin | Experimental | liposomal doxorubicin(PLD) 35 mg/m2,iv,d1, plus cisplatin 75 mg/m2,drip,d1-3, once every 21days, for 6 cycles, to progression or intolerance. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PLD | Drug | intravenous infusion of liposomal doxorubicin 35 mg/m2, d1,once every 21days, for 6 cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| disease control rate(DCR) | the rate of CR,PR and SD | disease control rate will be evaluated every 2 cycles (each cycle is 21 days) from date of administration of drugs until the date of first documented progression,up to 18 months. |
| Measure | Description | Time Frame |
|---|---|---|
| OS | overall survival | From date of randomization until the date of death from any cause,assessed up to 18 months. |
| PFS | progression-free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jiandong nie, doctor | Contact | 0311-66575708 | niejd@mail.ecspc.com |
| Name | Affiliation | Role |
|---|---|---|
| minghua ge, doctor | Zhejiang Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Recruiting | Zhejiang | China |
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| ID | Term |
|---|---|
| C041277 | 1-dodecylpyridoxal |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| Cisplatin | Drug | cisplatin 75 mg/m2, drip, total dose should be carried out on d1-3; once every 21days, for 6 cycles. |
|
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| From date of randomization until the date of first documented disease progression or date of death from any case,whichever came first,assessed up to 18 months. |
| Incidence of adverse events assessed by number and severity of adverse event in the treatment. | Evaluate the adverse reaction rate of drugs assessed by number and severity of adverse events in the treatment of advanced thyroid poorly differentiated carcinoma. | A summary of adverse events of each cycle,from date of administration of drugs until 30 days after the last chemotherapy or progression,whichever came first,assessed up to 18 months. |
| quality of life assessment | Evaluate the QoL according to Functional Assessment of Cancer Therapy. | It will be assessed before the administration of drugs at each first day of the chemotherapy cycle,up to 6 cycles,each cycle is 21 days. |