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

This study is currently recruiting participants.
Verified July 2011 by Samsung Medical Center
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01126008
First received: May 17, 2010
Last updated: July 21, 2011
Last verified: July 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Head and Neck Cancer
 Drug: CCRT with weekly docetaxel & cisplatin
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Concurrent Chemoradiotherapy With Weekly Docetaxel and Cisplatin for Locally Advanced Head and Neck Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Complete response rate [ Time Frame: 3-4 weeks after completion of CCRT ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • quality of life [ Time Frame: Pretreatment & 3-4 weeks after completion of treatment ] [ Designated as safety issue: Yes ]
  • overall survival rate [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
  • disease free survival rate [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 44
Study Start Date: December 2009
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: weekly docetaxel and cisplatin 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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01126008

Contacts
Contact: Keunchil Park, M.D, Ph.D. 822-3410-3450 kpark@skku.edu

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Keunchil Park, M.D., Ph.D     822-3410-3450     kpark@skku.edu    
Principal Investigator: Keunchil Park, M.D., Ph.D.            
Sub-Investigator: Myung-Ju Ahn, M.D., Ph.D.            
Sponsors and Collaborators
Samsung Medical Center
  More Information

No publications provided

Responsible Party: Keunchil Park , M.D., Ph.D., Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01126008     History of Changes
Other Study ID Numbers: 2009-10-007
Study First Received: May 17, 2010
Last Updated: July 21, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Samsung Medical Center:
locally advanced Squamous cell carcinoma

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Docetaxel
Cisplatin
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013