Head and Neck Cancer Clinical Trial
Official title:
Concurrent Chemotherapy Based on Genetic Testing in Patients With High-Risk Salivary Gland Tumors
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | August 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. Pathologically proven diagnosis of a malignant salivary gland tumor of intermediate or high-grade 2. Pathologic stage T3-4 or N1-3 or T1-2, N0 with a close (= 5mm) or microscopically positive surgical margin 3. Surgical resection with curative intent within 8 weeks prior to registration, with no evidence of gross tumor residual 4. No evidence of distant metastases 5. No synchronous or concurrent head and neck primary tumors 6. Karnofsky score over 60 7. Adequate organ function including the following: 1. Absolute neutrophil count (ANC) >= 1.5 * 10^9/l 2. Platelets count >= 100 * 10^9/l 3. Hemoglobin >= 10 g/dl 4. AST and ALT <= 2.5 times institutional upper limit of normal (ULN) 5. Total bilirubin <= 1.5 times institutional ULN 6. Creatinine clearance >= 50 ml/min 7. Serum creatine <= 1 times ULN 8. Signed written informed consent Exclusion Criteria: 1. Evidence of distant metastasis 2. Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region 3. Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma 4. Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures 5. 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 |
Country | Name | City | State |
---|---|---|---|
China | Shanghai ninth people's hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Acute toxicity profiles, graded according to the NCI CTCAE version 3.0 | up to 6 weeks | ||
Secondary | 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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