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This study is designed to evaluate the feasibility and safety of concurrent chemoradiotherapy for limited advanced unresectable thymoma or thymic carcinoma.
Complete resection is difficult to achieve without damaging the main organs in advanced thymoma or thymic carcinoma. The previous trials have showed that radiotherapy was significantly associated with prolonged OS and chemotherapy is playing an increasing role in treatment of patients with advanced thymoma or thymic carcinoma. However, whether concurrent chemoradiotherapy is safety in advanced thymoma or thymic carcinoma is still unknown. The purpose of this study is to evaluate the feasibility and safety of concurrent chemoradiotherapy for limited advanced unresectable thymoma or thymic carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| chemoradiation | Experimental | concurrent chemoradiation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| concurrent chemoradiation | Radiation | The patients receive chemotherapy concurrent with Radiotherapy. The prescription dose is 60Gy in 30 fractions in 6 weeks.The chemotherapy regimen is cisplatin (25mg/m2,iv drip,d1-3) and etoposide (75mg/m2,iv drip,d1-3),q4w*4. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | Evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) 1.0 criteria | 3 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | from registration to death as a result of any cause. | 2 years |
| Progression free survival | from registration to first documentation of disease progression or death. |
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Inclusion Criteria:
1.18~75 years old; 2.Eastern Cooperative Oncology Group performance status of 0 to 2; 3.Pathologically or cytologically confirmed untreated thymoma or thymic carcinoma; 4.Unresectable, limited adanced disease could be encompassed within a tolerable radiotherapy field; 5.Have adequate bone marrow, hepatic, and renal function; 6.Patients who cannot receive surgery resection; 7.Written informed consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kailiang Wu, M.D.,Ph.D | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kailiang Wu | Shanghai | Shanghai Municipality | 20032 | China |
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| ID | Term |
|---|---|
| D013945 | Thymoma |
| ID | Term |
|---|---|
| D018193 | Neoplasms, Complex and Mixed |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D013953 | Thymus Neoplasms |
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Intensity modulated radiotherapy with VP-16/Cisplatin
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| 2 years |
| Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v4.0 | Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v4.0 | up to 2 years |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |