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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01126008
First Posted: May 19, 2010
Last Update Posted: April 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Keunchil Park, Samsung Medical Center
  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: Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by Keunchil Park, Samsung Medical Center:

Primary Outcome Measures:
  • Complete response rate [ Time Frame: 3-4 weeks after completion of CCRT ]

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

Estimated Enrollment: 44
Study Start Date: December 2009
Estimated Study Completion Date: December 2016
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01126008


Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
  More Information

Responsible Party: Keunchil Park, Principal investigator, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01126008     History of Changes
Other Study ID Numbers: 2009-10-007
First Submitted: May 17, 2010
First Posted: May 19, 2010
Last Update Posted: April 20, 2016
Last Verified: April 2016

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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Docetaxel
Cisplatin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action