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To observe the efficacy and toxicities of post-operative (R0/R1) proton radiotherapy for locally advanced primary thymus epithelial malignancies. The primary endpoint was progression-free survival and toxicities, and the secondary endpoint was overall survival and cause-specific survival.
Patients who received R0 resection will receive 45GyE per 18 fractions proton irradiation. Patients who received R1 resection will receive 50GyE per 20 fractions proton irradiation. Patients with thymus cancer should receive combined platinum based chemotherapy (including etoposide combined with cisplatin / carboplatin / loplatin / nedaplatin, paclitaxel combined with cisplatin / carboplatin / loplatin / nedaplatin, Docetaxel combined with cisplatin / carboplatin / loplatin / nedaplatin) for at least 4 cycles. The primary endpoint was progression-free survival and toxicities, and the secondary endpoint was overall survival and cause-specific survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study arm | Experimental | Patients who received R0 resection will receive 45GyE per 18 fractions proton irradiation. Patients who received R1 resection will receive 50GyE per 20 fractions proton irradiation. Patients with thymus cancer should receive combined platinum based chemotherapy (including etoposide combined with cisplatin / carboplatin / loplatin / nedaplatin, paclitaxel combined with cisplatin / carboplatin / loplatin / nedaplatin, Docetaxel combined with cisplatin / carboplatin / loplatin / nedaplatin) for at least 4 cycles. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proton radiotherapy | Radiation | Patients who received R0 resection will receive 45GyE per 18 fractions proton irradiation. Patients who received R1 resection will receive 50GyE per 20 fractions proton irradiation. Patients with thymus cancer should receive combined platinum based chemotherapy (including etoposide combined with cisplatin / carboplatin / loplatin / nedaplatin, paclitaxel combined with cisplatin / carboplatin / loplatin / nedaplatin, Docetaxel combined with cisplatin / carboplatin / loplatin / nedaplatin) for at least 4 cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease progression-free survival rate | Disease progression-free survival rate was defined from the start of carbon ion radiotherapy till the date of disease progression at any site or death, or the last follow up. | From date of radiotherapy started until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months. |
| Incidence of Treatment-induced Adverse Events | Treatment-induced toxicities were scored using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, for events observed after the first dose of irradiation. Toxicities occurred 90 or more days after the completion of CIRT were defined as late toxicities. | From date of radiotherapy started, every 3-4 months within the first 2 years, every 6 months between years 3 and 5, and annually thereafter, assessed up to 100 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival rate | Overall survival rate was defined from the start of carbon ion radiotherapy till the date of death or the last follow-up. | From date of radiotherapy started until the date of death from any cause, assessed up to 100 months. |
| Cause-specific survival rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Li | Contact | 86-21-38296678 | jing.li@sphic.org.cn | |
| Kun Liu | Contact | 86-21-38296678 | kun.liu@sphic.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jingfang Mao, PHD | Shanghai Proton and Heavy Ion Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Proton and Heavy Ion Center | Recruiting | Shanghai | Shanghai Municipality | 201513 | China |
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| ID | Term |
|---|---|
| C536905 | Thymic epithelial tumor |
| D011832 | Radiation Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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|
| combined platinum based chemotherapy | Other | combined platinum based chemotherapy |
|
Cause-specific survival rate was defined from the start of carbon ion radiotherapy till the date of death caused by non-small cell lung cancer treated in this study or the last follow-up. |
| From date of radiotherapy started until the date of death caused by non-small cell lung cancer treated in this study, assessed up to 100 months. |