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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01126008
• Other study ID #: 2009-10-007
• Status: Completed
• Phase: Phase 2
• Start date: November 16, 2009
• Est. completion date: April 15, 2016

Study information

• Verified date: March 2021
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: April 15, 2016
• Est. primary completion date: April 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 - ?B 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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• CCRT with weekly docetaxel & cisplatin
radiotherapy: 70Gy/35 fraction for 7 weeks chemotherapy: docetaxel 20mg/m2 and cisplatin 20mg/m2 weekly for 6 weeks

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete response rate		3-4 weeks after completion of CCRT
Secondary	quality of life		Pretreatment & 3-4 weeks after completion of treatment
Secondary	overall survival rate		2 year
Secondary	disease free survival rate		2 year