Head and Neck Cancer
Conditions
Keywords
locally advanced Squamous cell carcinoma
Brief summary
This phase II trial is evaluating the efficacy of concurrent chemoradiation therapy with weekly docetaxel and cisplatin combination regimen.
Detailed description
Many studies have shown the superiority of concurrent chemoradiotherapy over radiotherapy only in locally advanced head and neck cancer. Concurrent chemoradiotherapy with high dose cisplatin has been universally used regimen. In a large-scaled phase II trial, however, conducted by the European Organization for the Research and Treatment of Cancer (EORTC), docetaxel (100mg/m2) plus cisplatin (75mg/ m2) every three weeks regimen produced improved survival, nonetheless there was significant limitation to deliver full doses of treatment due to significant hematologic and non-hematologic toxicities. Previously, we showed the safety of the combination regimen of weekly docetaxel and cisplatin in concurrent chemoradiation treatment in a phase I study. We determined the MTD of docetaxel to be 20mg/m2 weekly when concurrently administered with conventional fractionation RT and weekly 20mg/m2 of cisplatin.
Interventions
DRUGCCRT with weekly docetaxel & cisplatin
radiotherapy: 70Gy/35 fraction for 7 weeks chemotherapy: docetaxel 20mg/m2 and cisplatin 20mg/m2 weekly for 6 weeks
Sponsors
Samsung Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed squamous cell carcinoma of the head and neck (SCCHN) of one of following sites : oral cavity, oropharynx, larynx, or hypopharynx 2. Unresectable Stage III - ⅣB disease 3. previously untreated for head & Neck cancer with chemotherapy or radiotherapy 4. 18 and over 5. Performance status ECOG 0-1 6. Absolute neutrophil count ≥ 1,500/mm3 7. Platelet count ≥ 75,000/mm3 8. Hemoglobin \> 9.0 g/dL 9. Bilirubin ≤ 1.5 times upper limit of normal (ULN) 10. AST or ALT, and alkaline phosphatase meeting 1 of the following parameters:Alkaline phosphatase ≤ 1.5 times ULN AND AST or ALT ≤ 5 times ULN Alkaline phosphatase ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN Alkaline phosphatase ≤ 5 times ULN AND AST or ALT ≤ ULN 11. serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 60 ml/min
Exclusion criteria
1. Distant metastatic disease (M1) 2. Prior chemotherapy or RT for Head and neck cancer 3. Synchronous or concurrent head and neck primary tumors 4. Lip, nasopharynx, nasal cavity, salivary gland, or sinuses 5. No other invasive malignancy within the past 3 years except nonmelanoma skin cancer or papillary thyroid cancer 6. Other concurrent illness that would preclude study participation 7. Other concurrent physical condition (e.g., infectious disease) that would preclude study participation 8. pregnant or nursing 9. Fertile patients must use effective contraception during and for 3 months after study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate | 3-4 weeks after completion of CCRT |
Secondary
| Measure | Time frame |
|---|---|
| quality of life | Pretreatment & 3-4 weeks after completion of treatment |
| overall survival rate | 2 year |
| disease free survival rate | 2 year |
Countries
South Korea
Outcome results
None listed