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This is a non-randomized, phase II, open label study of postoperative current chemoradiotherapy for high-risk malignant salivary gland tumors of head and neck.The primary purpose of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy in these patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACC | Experimental | Intensity-modulated radiotherapy+concurrent chemotherapy with docetaxel and Nedaplatin |
|
| Non-ACC | Experimental | Intensity-modulated radiotherapy+concurrent chemotherapy with docetaxel and Nedaplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nedaplatin | Drug | nedaplatin 35mg/m^2,D1-2,2 cycles |
| |
| 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:
Pathologically proven diagnosis of a malignant salivary gland tumor of intermediate or high-grade
Pathologic stage T3-4 or N1-3 or T1-2, N0 with a close (≤ 5mm) or microscopically positive surgical margin
Surgical resection with curative intent within 8 weeks prior to registration, with no evidence of gross tumor residual
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, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai ninth people's hospital | Shanghai | Shanghai Municipality | 200011 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41878954 | Derived | Dou S, Wang X, Zhang L, Jiang W, Ye L, Wang Y, Li R, Zhu G. Long-Term Survival Outcomes of Concurrent Chemoradiotherapy for Postoperative High-Risk Salivary Gland Carcinomas. Cancer Med. 2026 Mar;15(3):e71722. doi: 10.1002/cam4.71722. |
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| Docetaxel |
| Drug |
Docetaxel 70mg/m^2,D1,2 cycles |
|
| Intensity-modulated radiotherapy | Radiation | a total dose of 60-66Gy in 30-33 fractions over 6-7 weeks |
|
Number of participants with treatment-related acute toxicity as assessed weekly by CTCAE v3.0 during the course of treatment
| up to 6 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 |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C053989 | nedaplatin |
| 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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