Postoperative Concurrent Chemoradiotherapy in Treating Patients With High-Risk Malignant Salivary Gland Tumors

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Postoperative Concurrent Chemoradiotherapy in Treating Patients With High-Risk Malignant Salivary Gland Tumors of Head and Neck, A Non-Randomized, Phase II Trial

Conditions
-----------------
Salivary Gland Tumors, Head and Neck Cancer

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


Participation Criteria
=================
Eligibility Criteria
-----------------
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
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cisplatin Group<br>Intensity-modulated radiotherapy+concurrent chemotherapy with cisplatin for squamous carcinoma of salivary gland | Drug: Cisplatin<br>* Cisplatin 80mg/m^2，D1-3，2 cycles<br>* Other names: Platinol;Radiation: Intensity-modulated radiotherapy<br>* a total dose of 60-66Gy in 30-32 fractions over 6-7 weeks<br>|
| Experimental: Docetaxel+Cisplatin<br>Intensity-modulated radiotherapy+concurrent chemotherapy with docetaxel and cisplatin for adenogenous types carcinoma of salivary gland | Drug: Cisplatin<br>* Cisplatin 80mg/m^2，D1-3，2 cycles<br>* Other names: Platinol;Drug: Docetaxel<br>* Docetaxel 70mg/m^2，D1，2 cycles<br>* Other names: Taxotere;Radiation: Intensity-modulated radiotherapy<br>* a total dose of 60-66Gy in 30-32 fractions over 6-7 weeks<br>|

What is the study measuring?
-----------------
Primary 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Salivary Gland Tumors, Head-an-Neck cancer, Concurrent Chemoradiotherapy, High-Risk, Cisplatin, Docetaxel