Concomitant Chemoradiotherapy (CCRT) With Weekly Docetaxel and Cisplatin for Locally Advanced Head and Neck Cancer

• Status: Completed
• Trial end date: 2016-04-15
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Medical Center
• Treatments: Cisplatin; Docetaxel

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