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A Phase II Trial of Concurrent Chemoradiotherapy With Weekly Docetaxel and Cisplatin for Locally Advanced Head and Neck Cancer

Phase 2
18 Years
Open (Enrolling)
Head and Neck Cancer

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Trial Information

A Phase II Trial of Concurrent Chemoradiotherapy With Weekly Docetaxel and Cisplatin for Locally Advanced Head and Neck Cancer

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.

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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete response rate

Outcome Time Frame:

3-4 weeks after completion of CCRT

Safety Issue:



Korea: Food and Drug Administration

Study ID:




Start Date:

December 2009

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • locally advanced Squamous cell carcinoma
  • Head and Neck Neoplasms