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This is a non-randomized, phase II, open label study of postoperative concurrent chemoradiotherapy with docetaxel for high-risk squamous cell carcinoma of the head and neck(HNSCC).The primary purpose of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy with docetaxel in HNSCC patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Docetaxel Group | Experimental | Concurrent Chemoradiotherapy With Docetaxel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | Docetaxel: 20mg/m2/w for 6 weeks |
| |
| Intensity-modulated radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival | from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 2 years | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival rate | from date of enrollment until date of first death from any cause, assessed up to 2 years | 2 years |
| Acute toxicity profiles, graded according to the NCI CTCAE version 3.0 |
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Inclusion Criteria:
Histologically confirmed squamous cell carcinoma of the head and neck.Site of tumor origin in the oral cavity, oropharynx, larynx, or hypopharynx (excluding nasopharynx, or sinuses)
Gross total resection, with pathology demonstrating one or more of the following risk factors:
No evidence of distant metastases
No synchronous or concurrent head and neck primary tumors
Karnofsky score over 60
Adequate organ function including the following:
Signed written informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guopei Zhu, M.D. | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai ninth people's hospital | Shanghai | Shanghai Municipality | 200011 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32126267 | Derived | Li R, Jiang W, Dou S, Zhong L, Sun J, Zhang C, Zhu G. A Phase 2 Trial of Chemoradiation Therapy Using Weekly Docetaxel for High-Risk Postoperative Oral Squamous Cell Carcinoma Patients. Int J Radiat Oncol Biol Phys. 2020 Jul 1;107(3):462-468. doi: 10.1016/j.ijrobp.2020.02.464. Epub 2020 Feb 29. |
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| Radiation |
a total dose of 60Gy in 30 fractions over 6 weeks |
|
|
Number of participants with treatment-related acute toxicity as assessed weekly by CTCAE v3.0 during the course of treatment
| up to 6-7 weeks |
| Late toxicity profiles, graded according to the NCI CTCAE version 3.0 | Number of participants with treatment-related late toxicity as assessed every 3 months by CTCAE v3.0 up to 2 years | up to 2 years |
| Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Core 35 (EORTC QLQ-HN35) during the concurrent treatment | QoL score will be documented on each weekend during the course of radiotherapy | participants will be followed for the duration of hospital stay, an expected average of 6 weeks |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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