Clinical trial NCT01126008: Concomitant Chemoradiotherapy (CCRT) With Weekly Docetaxel and Cisplatin for Locally Advanced Head and Neck Cancer
Official title: A Phase II Trial of Concurrent Chemoradiotherapy With Weekly Docetaxel and Cisplatin for Locally Advanced Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
Keywords: locally advanced Squamous cell carcinoma
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2010-05-19
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Complete response rate
timeFrame: 3-4 weeks after completion of CCRT
Secondary outcomes:
measure: quality of life
timeFrame: Pretreatment & 3-4 weeks after completion of treatment
measure: overall survival rate
timeFrame: 2 year
measure: disease free survival rate
timeFrame: 2 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References: