Concomitant Chemoradiotherapy (CCRT) With Weekly Docetaxel and Cisplatin for Locally Advanced Head and Neck Cancer
Conditions
Head and Neck Cancer
Conditions: official terms
Head and Neck Neoplasms
Conditions: Keywords
locally advanced Squamous cell carcinoma
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: CCRT with weekly docetaxel & cisplatin
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
Samsung Medical Center
Seoul, Korea, Republic of
Status: Recruiting
Contact: Keunchil Park, M.D., Ph.D - 822-3410-3450 - kpark@skku.edu
Start Date
December 2009
Completion Date
December 2016
Sponsors
Samsung Medical Center
Source
Samsung Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page