Head and Neck Cancer, Salivary Gland Tumors
Conditions
Keywords
Salivary Gland Tumors, Head and Neck Cancer, concurrent chemotherapy, genetic testing
Brief summary
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.
Interventions
DRUGDocetaxel
Docetaxel only: 80 mg/m2 on day one, every 21 days if
RADIATIONIntensity-modulated radiotherapy
a total dose of 60-66Gy in 30-32 fractions over 6-7 weeks
DRUGPemetrexed
Pemetrexed only: 500 mg/m2 on day one, every 21 days
DRUGCisplatin
Cisplatin only: 70 mg/m2 on day one to day three, every 21 days
Sponsors
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute toxicity profiles, graded according to the NCI CTCAE version 3.0 | up to 6 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival | 2 years | from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 2 years |
Countries
China
Outcome results
None listed