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The goal of this clinical trial is to learn the role of adjuvant chemotherapy for patients with thymic carcinoma and completed resection. The main questions it aims to answer are:
Researchers will compare chemoradiotherapy to radiotherapy to see whether chemoradiotherapy could decrease disease progression or not.
Participants will:
Thymic carcinomas are rare neoplasms found in the anterior mediastinum, with an incidence of 0.38 cases per 100,000 people. Surgery is the primary treatment for patients with thymic carcinomas, and complete surgical resection proves fundamental for enhancing survival. However, the necessity for adjuvant therapy and the optimal type thereof for patients who have undergone complete resection remain unclear due to the lack of high-quality studies.
Our previous retrospective study found that radiotherapy improved overall survival and disease progression free survival significantly for all patients with thymic carcinoma and completed resection, however, chemotherapy only improved disease progression free survival for patients of stage III/IV. We also found that chemotherapy regimens containing paclitaxel were an advantageous combination for thymic cancer, and 1 or 2 cycles of adjuvant chemotherapy were better than more cycles, suggesting reduced dose chemotherapy.
DCF (docetaxel, cisplatin, 5-FU) or TPF (paclitaxel, cisplatin, 5-FU) were widely used in head and neck, esophageal, stomach, and anal canal cancer, and better effect were presented. However, the toxicity of full dose was too toxic to tolerate. Our previous experience in esophageal cancer found TPF with 2/3 of standard dose was well tolerance. Therefore, medium dose of TPF three drugs chemotherapy were chosed to balance efficacy and toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiotherapy Arm | Active Comparator | Radiotherapy (50Gy/25f), IMRT |
|
| Chemoradiotherapy Arm | Experimental | 2 cycle of chemotherapy, and then radiotherapy of 50Gy/25f,and then another 2 cycle of chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemotherapy | Drug | paclitaxel 60mg/m2, ivgtt; cisplatin 30mg/m2, ivgtt; 5-FU 500mg/m2, ivgtt and 500mg/m2, civ 24h; calcium folinate 200mg; q3w. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival | From surgery to any disease relapse or death | 3 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | from surgery to any death | 3 year |
| Disease Specific Survival | from surgery to death related to thymic carcinoma | 3 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xingwen Fa, Doctor | Contact | +8613651669687 | wenxingfan@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 212013 | 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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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Radiotherapy | Radiation | IMRT, 50Gy/25f |
|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |