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The prognosis of locally advanced oral squamous cell carcinoma(OSCC ) is poor, and there are still many problems to be solved in the current treatment paradigm. Neoadjuvant chemotherapy combined with immunotherapy can significantly improve the pCR and MPR rates in patients with locally advanced OSCC. For patients who achieve pCR and MPR after neoadjuvant therapy and surgery, it is still hotly debated regarding whether to implement postoperative de-escalation radiotherapy. Neoadjuvant therapy is an ideal predictor of radiosensitivity. In theory, neoadjuvant therapy can eliminate microscopic lesions, thereby reducing the dose and volume of irradiation.
Continuous hyperfractionated accelerated radiotherapy (CHART, based on hyperfractionated radiotherapy, increasing daily or weekly treatments and shortening the total treatment duration, but reducing the total dose), is to give a higher dose of radiation to tumor tissue in a shorter period of time, so as to overcome the accelerated reproliferation and inhibit the repair of sublethal damage of tumor cells. It is beneficial to improve the local control rate of tumor, control the acute injury of normal tissue and the yield acceptable late treatment-related complications. The specific protocol was as follows: high-risk CTV area (CTV1), 45Gy in total, fraction dose of 1.5Gy, twice a day, bioequivalent dose (BED) of 51.75Gy; Low-risk CTV area(CTV2), 39Gy in total , fraction dose of 1.3Gy, twice a day, BED of 44.07Gy; A total of 30 radiotherapy fraction were performed 10 times a week for 3 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous hyperfractionated accelerated radiotherapy(CHART) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous, hyperfractionated, accelerated radiotherapy(CHART) | Radiation | high-risk CTV area (CTV1), 45Gy in total, fraction dose of 1.5Gy, twice a day, bioequivalent dose (BED) of 51.75Gy; Low-risk CTV area(CTV2), 39Gy in total , fraction dose of 1.3Gy, twice a day, BED of 44.07Gy; A total of 30 radiotherapy fraction were performed 10 times a week for 3 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 2-year PFS | PFS is the time from the initiation of therapy to recurrence or death of any cause. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 2-year OS | OS is defined as the time interval from the beginning of treatment to death. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bi Zhuofei, Dr. | Contact | 13632301621 | bizhf@mail.sysu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen Memorial hospital, Sun Yat-sen University | Recruiting | Guangzhou | China |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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