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Docetaxel and S-1 Followed By Radiation Therapy and Low-Dose Cisplatin in Treating Patients With Stage III or Stage IV Head and Neck Cancer

Primary Purpose

Head and Neck Cancer

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
cisplatin
docetaxel
tegafur-gimeracil-oteracil potassium
radiation therapy
Sponsored by
Yonsei University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, stage III verrucous carcinoma of the oral cavity, stage IV verrucous carcinoma of the oral cavity, stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, stage III lymphoepithelioma of the nasopharynx, stage III squamous cell carcinoma of the nasopharynx, stage IV lymphoepithelioma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx, stage III lymphoepithelioma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, stage IV lymphoepithelioma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, tongue cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Pathologically confirmed head and neck cancer arising from the oral cavity, oropharynx, hypopharynx, or nasopharynx, including any of the following subtypes:

    • Squamous cell carcinoma
    • Poorly differentiated carcinoma
    • Lymphoepithelioma
  • Locally advanced disease (stage III or IV [M0] disease)
  • At least 1 unidimensionally measurable index lesion

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9 g/dL
  • Bilirubin ≤ 1.5 times the upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 3.0 times ULN
  • AST and ALT ≤ 3.0 times ULN
  • Creatinine ≤ 1.5 times ULN
  • No concurrent serious systemic disorder that, in the opinion of investigator, would compromise the patient's ability to complete the study

  • No serious cardiac condition, including any of the following:

    • Myocardial infarction within the past 6 months
    • Angina
    • NYHA class III-IV heart disease
  • No active infection requiring IV antibiotics, including active tuberculosis or HIV
  • No other malignancy within the past 5 years except basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
  • Able to comply with protocol or study procedures

PRIOR CONCURRENT THERAPY:

  • No prior radiotherapy or chemotherapy

Sites / Locations

  • Yonsei Cancer Center at Yonsei University Medical CenterRecruiting

Outcomes

Primary Outcome Measures

Objective response rate (complete or partial response) as assessed by RECIST criteria

Secondary Outcome Measures

Progression-free survival
Overall survival
Toxicity as assessed by NCI CTCAE v3.0 criteria

Full Information

First Posted
February 28, 2008
Last Updated
February 25, 2011
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT00625937
Brief Title
Docetaxel and S-1 Followed By Radiation Therapy and Low-Dose Cisplatin in Treating Patients With Stage III or Stage IV Head and Neck Cancer
Official Title
A Phase ll Trial of Induction Docetaxel and S-1 Followed by Concomitant Radiotherapy With Low-dose Daily Cisplatin in Locally Advanced Head and Neck Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2006 (undefined)
Primary Completion Date
November 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Yonsei University

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, S-1, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving docetaxel and S-1 together with radiation therapy and low-dose cisplatin works in treating patients with stage III or stage IV head and neck cancer.
Detailed Description
OBJECTIVES: Primary To assess the response rate in patients with stage III or IV head and neck cancer treated with induction therapy comprising docetaxel and S-1 followed by radiotherapy and low-dose cisplatin. Secondary To assess the effect of this regimen on survival and locoregional and systemic control rates in these patients. OUTLINE: Induction chemotherapy: Patients receive oral S-1 twice daily on days 1-14 and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Chemoradiotherapy: Patients receive low-dose cisplatin IV once daily and undergo radiotherapy 5 days a week for 7 weeks in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed periodically for 18 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, stage III verrucous carcinoma of the oral cavity, stage IV verrucous carcinoma of the oral cavity, stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, stage III lymphoepithelioma of the nasopharynx, stage III squamous cell carcinoma of the nasopharynx, stage IV lymphoepithelioma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx, stage III lymphoepithelioma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, stage IV lymphoepithelioma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, tongue cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Drug
Intervention Name(s)
tegafur-gimeracil-oteracil potassium
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Objective response rate (complete or partial response) as assessed by RECIST criteria
Secondary Outcome Measure Information:
Title
Progression-free survival
Title
Overall survival
Title
Toxicity as assessed by NCI CTCAE v3.0 criteria

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Pathologically confirmed head and neck cancer arising from the oral cavity, oropharynx, hypopharynx, or nasopharynx, including any of the following subtypes: Squamous cell carcinoma Poorly differentiated carcinoma Lymphoepithelioma Locally advanced disease (stage III or IV [M0] disease) At least 1 unidimensionally measurable index lesion PATIENT CHARACTERISTICS: ECOG performance status 0-2 ANC ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ Hemoglobin ≥ 9 g/dL Bilirubin ≤ 1.5 times the upper limit of normal (ULN) Alkaline phosphatase ≤ 3.0 times ULN AST and ALT ≤ 3.0 times ULN Creatinine ≤ 1.5 times ULN No concurrent serious systemic disorder that, in the opinion of investigator, would compromise the patient's ability to complete the study No serious cardiac condition, including any of the following: Myocardial infarction within the past 6 months Angina NYHA class III-IV heart disease No active infection requiring IV antibiotics, including active tuberculosis or HIV No other malignancy within the past 5 years except basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix Able to comply with protocol or study procedures PRIOR CONCURRENT THERAPY: No prior radiotherapy or chemotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joo-Hang Kim, MD
Organizational Affiliation
Yonsei University
Official's Role
Study Chair
Facility Information:
Facility Name
Yonsei Cancer Center at Yonsei University Medical Center
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joo-Hang Kim, MD
Phone
82-2-2228-8131
Email
kjhang@yuhs.ac

12. IPD Sharing Statement

Learn more about this trial

Docetaxel and S-1 Followed By Radiation Therapy and Low-Dose Cisplatin in Treating Patients With Stage III or Stage IV Head and Neck Cancer

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