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

Phase 2

Completed

• Conditions: Head and Neck Cancer
• Interventions: Drug: CCRT with weekly docetaxel & cisplatin

• Registration Number: NCT01126008
• Lead Sponsor: Samsung Medical Center

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.

Study Timeline

• Study Start: 2009-11-16
• Study First Submitted: 2010-05-17
• Study First Submitted QC: 2010-05-18
• Study First Posted: 2010-05-19
• Primary Completion: 2016-04-15
• Study Completion: 2016-04-15
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-18
• Last Update Posted: 2021-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
weekly docetaxel and cisplatin	CCRT with weekly docetaxel & cisplatin	-

Primary Outcome Measures

Name	Time	Method
Complete response rate	3-4 weeks after completion of CCRT

Secondary Outcome Measures

Name	Time	Method
overall survival rate	2 year
quality of life	Pretreatment & 3-4 weeks after completion of treatment
disease free survival rate	2 year

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of