Concurrent Chemotherapy Based on Genetic Testing in Patients With High-Risk Salivary Gland Tumors

Study Overview
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Brief Summary
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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.

Official Title
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Concurrent Chemotherapy Based on Genetic Testing in Patients With High-Risk Salivary Gland Tumors

Conditions
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Salivary Gland Tumors, Head and Neck Cancer

Intervention / Treatment
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* Drug: Docetaxel
* Radiation: Intensity-modulated radiotherapy
* Drug: Pemetrexed
* Drug: Cisplatin


Participation Criteria
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Eligibility Criteria
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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: Absolute neutrophil count (ANC) >= 1.5 * 10^9/l Platelets count >= 100 * 10^9/l Hemoglobin >= 10 g/dl AST and ALT <= 2.5 times institutional upper limit of normal (ULN) Total bilirubin <= 1.5 times institutional ULN Creatinine clearance >= 50 ml/min Serum creatine <= 1 times ULN Signed written informed consent Exclusion Criteria: Evidence of distant metastasis Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Docetaxel arm<br>Concurrent chemotherapy with Docetaxel if genetic testing show that the patient should be sensitive to this drug. | Drug: Docetaxel<br>* Docetaxel only: 80 mg/m2 on day one, every 21 days if<br>Radiation: Intensity-modulated radiotherapy<br>* a total dose of 60-66Gy in 30-32 fractions over 6-7 weeks<br>|
| Experimental: Pemetrexed arm<br>Concurrent chemotherapy with Pemetrexed if genetic testing show that the patient should be sensitive to this drug. | Radiation: Intensity-modulated radiotherapy<br>* a total dose of 60-66Gy in 30-32 fractions over 6-7 weeks<br>Drug: Pemetrexed<br>* Pemetrexed only: 500 mg/m2 on day one, every 21 days<br>|
| Experimental: Cisplatin arm<br>Concurrent chemotherapy with Cisplatin if genetic testing show that the patient was nor sensitive to neither Pemetrexed nor Docetaxel | Radiation: Intensity-modulated radiotherapy<br>* a total dose of 60-66Gy in 30-32 fractions over 6-7 weeks<br>Drug: Cisplatin<br>* Cisplatin only: 70 mg/m2 on day one to day three, every 21 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute toxicity profiles, graded according to the NCI CTCAE version 3.0 |  | up to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Salivary Gland Tumors, Head and Neck Cancer, concurrent chemotherapy, genetic testing