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Docetaxel and Radiation Therapy in Treating Patients With Stage II or Stage III Cancer of the Larynx or Hypopharynx

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
docetaxel
radiation therapy
Sponsored by
Aichi Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring stage II squamous cell carcinoma of the hypopharynx, stage II squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma of the larynx or hypopharynx Stage II or III disease Solitary lymph node metastasis located in level II-III allowed Age 70 and over OR meets 1 of the following criteria: Creatinine clearance 30-60 mL/min History of platinum allergy Diagnosis of unstable angina Ineligible for systemic chemotherapy, including high-dose platinum-containing regimens PATIENT CHARACTERISTICS: Age See Disease Characteristics Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic WBC > 3,000/mm^3 Neutrophil count > 1,500/mm^3 Hemoglobin > 10 g/dL Platelet count > 100,000/mm^3 Hepatic AST and ALT ≤ 2.0 times upper limit of normal Bilirubin < 2.0 mg/dL No severe liver disease Renal See Disease Characteristics Creatinine clearance ≥ 30 mL/min No severe renal disease Pulmonary No severe pulmonary disease Other No severe neurologic disease PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior systemic chemotherapy Endocrine therapy Not specified Radiotherapy No prior radiotherapy Surgery No prior surgery

Sites / Locations

  • Aichi Cancer Center
  • Hirosaki University, School of Medicine
  • Chiba University
  • Yokohama City University
  • Shinshu University Health Center
  • Hamamatsu University School of Medicine
  • National Hospital Organization - Medical Center of Kure
  • Nara Medical University Cancer Center
  • Graduate School of Medical Science at the University of Ryukyu

Outcomes

Primary Outcome Measures

Objective response of primary tumor

Secondary Outcome Measures

Local complete response rate
Local progression-free survival at 2 years
Local relapse-free survival
Larynx preservation survival at 2 years
Overall survival at 2 years
Treatment completion rate
Incidence of adverse effects

Full Information

First Posted
October 20, 2005
Last Updated
March 25, 2013
Sponsor
Aichi Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00243113
Brief Title
Docetaxel and Radiation Therapy in Treating Patients With Stage II or Stage III Cancer of the Larynx or Hypopharynx
Official Title
Multi-Institutional Phase II Study of Weekly Docetaxel and Concurrent Radiotherapy for Laryngeal and Hypopharyngeal Cancer in the Group of Elderly and/or Patients With Medical Illness
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Aichi Cancer Center

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel 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 docetaxel together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving docetaxel together with radiation therapy works in treating patients with stage II or stage III cancer of the larynx or hypopharynx.
Detailed Description
OBJECTIVES: Primary Determine the objective response of the primary tumor in patients with stage II or III squamous cell carcinoma of the larynx or hypopharynx treated with docetaxel and radiotherapy. Secondary Determine the local relapse-free survival of patients treated with this regimen. Determine the larynx-preservation survival of patients treated with this regimen. Determine the overall survival of patients treated with this regimen. Determine the protocol completion rate in patients treated with this regimen. Determine the adverse effects of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 1 hour on days 1, 8, 15, 22, and 29 and undergo radiotherapy on days 1-5, 8-12, 15-19, 22-26, and 29-33. PROJECTED ACCRUAL: A total of 25-50 patients will be accrued for this study.

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 II squamous cell carcinoma of the hypopharynx, stage II squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Objective response of primary tumor
Secondary Outcome Measure Information:
Title
Local complete response rate
Title
Local progression-free survival at 2 years
Title
Local relapse-free survival
Title
Larynx preservation survival at 2 years
Title
Overall survival at 2 years
Title
Treatment completion rate
Title
Incidence of adverse effects

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma of the larynx or hypopharynx Stage II or III disease Solitary lymph node metastasis located in level II-III allowed Age 70 and over OR meets 1 of the following criteria: Creatinine clearance 30-60 mL/min History of platinum allergy Diagnosis of unstable angina Ineligible for systemic chemotherapy, including high-dose platinum-containing regimens PATIENT CHARACTERISTICS: Age See Disease Characteristics Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic WBC > 3,000/mm^3 Neutrophil count > 1,500/mm^3 Hemoglobin > 10 g/dL Platelet count > 100,000/mm^3 Hepatic AST and ALT ≤ 2.0 times upper limit of normal Bilirubin < 2.0 mg/dL No severe liver disease Renal See Disease Characteristics Creatinine clearance ≥ 30 mL/min No severe renal disease Pulmonary No severe pulmonary disease Other No severe neurologic disease PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior systemic chemotherapy Endocrine therapy Not specified Radiotherapy No prior radiotherapy Surgery No prior surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nobukazu Fuwa
Organizational Affiliation
Aichi Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Aichi Cancer Center
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Hirosaki University, School of Medicine
City
Hirosaki
State/Province
Aomori
ZIP/Postal Code
036-8562
Country
Japan
Facility Name
Chiba University
City
Chiba City
State/Province
Chiba
ZIP/Postal Code
260-8677
Country
Japan
Facility Name
Yokohama City University
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
236-0004
Country
Japan
Facility Name
Shinshu University Health Center
City
Matsumoto
State/Province
Nagano
ZIP/Postal Code
390-8621
Country
Japan
Facility Name
Hamamatsu University School of Medicine
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
431-31
Country
Japan
Facility Name
National Hospital Organization - Medical Center of Kure
City
Hiroshima
ZIP/Postal Code
737-0023
Country
Japan
Facility Name
Nara Medical University Cancer Center
City
Nara
ZIP/Postal Code
634-8522
Country
Japan
Facility Name
Graduate School of Medical Science at the University of Ryukyu
City
Okinawa
ZIP/Postal Code
903-0215
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Docetaxel and Radiation Therapy in Treating Patients With Stage II or Stage III Cancer of the Larynx or Hypopharynx

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