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It is a randomized phase II study to determine the efficacy and safety of particle therapy with or without apatinib as induction therapy for the treatment of head and neck adenoid cystic carcinoma. Participants will be randomized to arm 1: receiving apatinib for 6 weekly followed by particle radiotherapy; arm 2: particle radiotherapy alone.
The purpose of this study is to determine the efficacy and safety of particle therapy with or without apatinib as induction therapy for the treatment of head and neck adenoid cystic carcinoma. It is a randomized phase II clinical trial with single phase and 2 experimental arms. Participants will be randomized to arm 1, receiving apatinib (0.5g, daily) for 6 weekly followed by particle radiotherapy (proton: 56 GyE/28 Fx, plus carbon: 15 GyE/5 Fx for boost); arm 2: particle radiotherapy alone (proton: 56 GyE/28 Fx, plus carbon: 15 GyE/5 Fx for boost). The short term response will be evaluated using RECIST criteria. And the acute and late toxicities will be evaluated according to NCI CTCAE v4.03.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apatinib with Particle Therapy | Experimental | Participants will receive apatinib (0.5g, daily) for 6 weekly followed by particle radiotherapy (proton: 56 GyE/28 Fx, plus carbon: 15 GyE/5 Fx for boost). |
|
| Particle Therapy | Experimental | Participants will receive particle radiotherapy alone (proton: 56 GyE/28 Fx, plus carbon: 15 GyE/5 Fx for boost). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib | Drug | Apatinib will be used as induction therapy in experimental arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Short-term treatment response of all patients | Three months after completion of particle therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by NCI CTCAE v4.03 | Time interval from start to 3 months after completion of particle therapy. | |
| Overall survival of all patients | From the diagnosis of H&N adenoid cystic carcinoma, a median of 3 years. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lin Kong, MD | Contact | lin.kong@sphic.org.cn | ||
| Jiyi Hu, MD | Contact | jiyi.hu@sphic.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jiade J Lu, MD | Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Proton and Heavy Ion Center | Recruiting | Shanghai | Shanghai Municipality | 201315 | China |
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| ID | Term |
|---|---|
| D003528 | Carcinoma, Adenoid Cystic |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C553458 | apatinib |
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| Particle Therapy | Radiation | Same total dose and fractionation will be used in both arms. |
|
| Progression-free survival of all patients | From the completion of the particle therapy, a median of 3 years. |
| Local progression-free survival of all patients | From the completion of the particle therapy, a median of 3 years. |
| Distant metastasis-free survival of all patients | From the completion of the particle therapy, a median of 3 years. |
| D009369 | Neoplasms |