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The role of postoperative concurrent chemotherapy (CCT) has not been established for salivary gland tumors (SGTs). This prospective study was conducted to evaluate the feasibility and safety of customized CCT regimens based on the gene targets of SGTs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Docetaxel arm | Experimental | Concurrent chemotherapy with Docetaxel if genetic testing show that the patient should be sensitive to this drug. |
|
| Pemetrexed arm | Experimental | Concurrent chemotherapy with Pemetrexed if genetic testing show that the patient should be sensitive to this drug. |
|
| Cisplatin arm | Experimental | Concurrent chemotherapy with Cisplatin if genetic testing show that the patient was nor sensitive to neither Pemetrexed nor Docetaxel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | Docetaxel only: 80 mg/m2 on day one, every 21 days if |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Acute toxicity profiles, graded according to the NCI CTCAE version 3.0 | up to 6 weeks |
| 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 |
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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 | 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 |
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| Intensity-modulated radiotherapy |
| Radiation |
a total dose of 60-66Gy in 30-32 fractions over 6-7 weeks |
|
| Pemetrexed | Drug | Pemetrexed only: 500 mg/m2 on day one, every 21 days |
|
| Cisplatin | Drug | Cisplatin only: 70 mg/m2 on day one to day three, every 21 days |
|
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D050397 | Radiotherapy, Intensity-Modulated |
| D000068437 | Pemetrexed |
| D002945 | Cisplatin |
| 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 |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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