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To determine the efficacy and safety of intensity modulated radiation therapy combined with apatinib for inoperable or iodine refractory thyroid cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apatinib with IMRT | Experimental | Participants will receive apatinib (0.5g, daily) for two cycles followed by intensity modulated radiation therapy (Primary site and lymph nodes: 66 Gy/33F, metastatic site: 40-60Gy/20-30F) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib | Drug | Apatinib will be used as induction therapy in experimental arm. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | The time from date of randomization until date of first documented disease progression or death from any cause | 3-year |
| Measure | Description | Time Frame |
|---|---|---|
| Short-term treatment response rate | Number of participants responded to the therapy according to RECIST 1.1 | Three months after completion of the therapy |
| Overall survival | Overall survival is calculated from randomization to death from any cause. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiayun He, MD,PhD | Contact | +86 13917564793 | hexiayun1962@163.com | |
| Fen Xue, MD | Contact | +86 18505123563 | xuefen1992@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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| ID | Term |
|---|---|
| C553458 | apatinib |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| Intensity modulated radiation therapy |
| Radiation |
Intensity modulated radiation therapy will be used for patients with progression disease during induction therapy or after induction therapy. |
|
| 3-year |
| Time to Response | Time to first response to the therapy according to RECIST 1.1 | From the initial treatment to first response, up to 3 years |
| Duration of Response | Time from the first response to the therapy to disease progression | From first response to disease progression, up to 3 years |
| Number of participants with treatment-related adverse events as assessed by NCI CTCAE v4.03 | Incidence of acute and late toxicity | Time interval from start to 3 months after completion of the therapy |
| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |