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

NCT01126008 | Completed Phase 2

• 1 other identifier: 2009-10-007
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Head and Neck Cancer

Keywords

locally advanced Squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

• Complete response rate

  3-4 weeks after completion of CCRT

Secondary Outcomes (3)

• quality of life

  Pretreatment & 3-4 weeks after completion of treatment

• overall survival rate

  2 year

• disease free survival rate

  2 year

Study Arms (1)

weekly docetaxel and cisplatin

EXPERIMENTAL

Drug: CCRT with weekly docetaxel & cisplatin

Interventions

CCRT with weekly docetaxel & cisplatin DRUG

radiotherapy: 70Gy/35 fraction for 7 weeks chemotherapy: docetaxel 20mg/m2 and cisplatin 20mg/m2 weekly for 6 weeks

weekly docetaxel and cisplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed squamous cell carcinoma of the head and neck (SCCHN) of one of following sites : oral cavity, oropharynx, larynx, or hypopharynx
• Unresectable Stage III - ⅣB disease
• previously untreated for head \& Neck cancer with chemotherapy or radiotherapy
• and over
• Performance status ECOG 0-1
• Absolute neutrophil count ≥ 1,500/mm3
• Platelet count ≥ 75,000/mm3
• Hemoglobin \> 9.0 g/dL
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• 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
• serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 60 ml/min

You may not qualify if:

• Distant metastatic disease (M1)
• Prior chemotherapy or RT for Head and neck cancer
• Synchronous or concurrent head and neck primary tumors
• Lip, nasopharynx, nasal cavity, salivary gland, or sinuses
• No other invasive malignancy within the past 3 years except nonmelanoma skin cancer or papillary thyroid cancer
• Other concurrent illness that would preclude study participation
• Other concurrent physical condition (e.g., infectious disease) that would preclude study participation
• pregnant or nursing
• Fertile patients must use effective contraception during and for 3 months after study participation

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Cisplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 17, 2010
• First Posted: May 19, 2010
• Study Start: November 16, 2009
• Primary Completion: April 15, 2016
• Study Completion: April 15, 2016
• Last Updated: March 22, 2021

Record last verified: 2021-03

Locations

KR (1)