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The goal of this clinical trial is to learn if hypofractionated radiotherapy works to shorten the treatment time without increasing the side effects in patients of thymic epithelial tumors. The main questions it aims to answer are:
Participants will:
According to the World Health Organization histological classification system, thymic epithelial tumors (TET) are divided into thymoma and thymic carcinoma. Surgery is the main treatment for thymic tumors, and radiotherapy (RT), as an important auxiliary method of surgery, also plays an irreplaceable role in all stages of thymoma.
Hypofractionated radiotherapy is a common mode of radiotherapy for thoracic tumors. Unlike conventional radiotherapy, hypofractionated radiotherapy has a higher single dose and a shorter course of treatment. Because it improves the treatment efficiency, it can reduce the treatment time of patients and medical institutions and the cost of patients.
In the postoperative radiotherapy stage, conventional radiotherapy and hypofractionated radiotherapy were used. The course of hypofractionated radiotherapy was shorter than that of conventional radiotherapy. Patients chose to accept hypofractionated radiotherapy as the hypofractionated group, but not the conventional group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypofractionated Radiotherapy | Experimental | R0 resection: 42-48 Gy/14-16f or 40-44 Gy or 10-11f,40 Gy/8f R1 resection: 48-51 Gy/16-17f or 44-48 Gy/11-12f or 40-45 Gy/8-9f R2 resection: 51-60 Gy/17-20f or 48-56 Gy/12-14f or 45 -60Gy/9-12f |
|
| Conventional Radiotherapy | No Intervention | R0 resection: 45-50Gy/20-25f R1 resection: 54-56Gy/25-28f R2 resection: 60-70Gy/30-35f |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypofractionated Radiation Therapy | Radiation | R0 resection: 45-50Gy/20-25f R1 resection: 54-56Gy/25-28f R2 resection: 60-70Gy/30-35f |
|
| Measure | Description | Time Frame |
|---|---|---|
| 3-year PFS | Time from enrollment to disease progression or death. | The patients were followed up for 3 years from enrollment to disease progression or death. |
| Measure | Description | Time Frame |
|---|---|---|
| toxicity | Any adverse medical event that occurred between the time the patient provided informed consent and was enrolled in the trial and the date of the last follow-up visit. | Patients were followed from enrollment until 3 years. |
| 3-year OS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rongrong Zhou, MD, PHD | Contact | +8613875898127 | zhourr@csu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Hospital, Central South University | Recruiting | Changsha | Hunan | 410000 | China |
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| ID | Term |
|---|---|
| D013945 | Thymoma |
| D013953 | Thymus Neoplasms |
| C536905 | Thymic epithelial tumor |
| ID | Term |
|---|---|
| D018193 | Neoplasms, Complex and Mixed |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D013899 | Thoracic Neoplasms |
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Time from patient enrollment to patient death.
| The patients were followed up for 3 years from enrollment to death. |
| D009371 |
| Neoplasms by Site |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |