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This is a randomized,controled, phase II, open label study of postoperative concurrent chemoradiotherapy with Docetaxel versus Cisplatin for high-risk squamous cell carcinoma of the oral cavity cancer.The primary purpose of this study is to evaluate the efficacy of concurrent chemoradiotherapy with docetaxel in OCC patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Concurrent Chemoradiotherapy With Docetaxel and IMRT |
|
| Control | Active Comparator | Concurrent Chemoradiotherapy With Cisplatinum and IMRT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | 20mg/m2/w |
| |
| Cisplatin |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival (DFS) | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | the time in months between the date of random assignment and the date of death from any cause | 2 years |
| Locoregional failure-free survival (LRFS) | the time in months between random assignment and the date of first locoregional recurrence or death from any cause, whichever occurred first |
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Inclusion Criteria:
1.Histologically confirmed squamous cell carcinoma of the oral cavity 2. Gross total resection, with pathology demonstrating one or more of the following risk factors:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guopei Zhu | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai ninth people's hospital | Shanghai | Shanghai Municipality | 200011 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39075531 | Derived | Jiang W, Chen L, Li R, Li J, Dou S, Ye L, He Y, Tian Z, Yao Y, Zhu G. Postoperative radiotherapy with docetaxel versus cisplatin for high-risk oral squamous cell carcinoma: a randomized phase II trial with exploratory analysis of ITGB1 as a potential predictive biomarker. BMC Med. 2024 Jul 29;22(1):314. doi: 10.1186/s12916-024-03541-6. |
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| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Drug |
100mg/m2/q3w |
|
| IMRT | Radiation | a total dose of 60Gy in 30fractions over 6 weeks |
|
| 2 years |
| distant metastasis free survival (DMFS) | the time from random assignment to the first distant metastasis or death from any cause | 2 years |
| Adverse Events (AE) | AEs were summarized and recorded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 | 3 months |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |