This trial is active, not recruiting.

Condition head and neck cancer
Treatment ccrt with weekly docetaxel & cisplatin
Phase phase 2
Sponsor Samsung Medical Center
Start date December 2009
End date August 2013
Trial size 44 participants
Trial identifier NCT01126008, 2009-10-007


This phase II trial is evaluating the efficacy of concurrent chemoradiation therapy with weekly docetaxel and cisplatin combination regimen.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
ccrt with weekly docetaxel & cisplatin
radiotherapy: 70Gy/35 fraction for 7 weeks chemotherapy: docetaxel 20mg/m2 and cisplatin 20mg/m2 weekly for 6 weeks

Primary Outcomes

Complete response rate
time frame: 3-4 weeks after completion of CCRT

Secondary Outcomes

quality of life
time frame: Pretreatment & 3-4 weeks after completion of treatment
overall survival rate
time frame: 2 year
disease free survival rate
time frame: 2 year

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Phase II Trial of Concurrent Chemoradiotherapy With Weekly Docetaxel and Cisplatin for Locally Advanced Head and Neck Cancer
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Samsung Medical Center.