NCT00243113

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_2 head-and-neck-cancer

Timeline
Completed

Started Jun 2004

Typical duration for phase_2 head-and-neck-cancer

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

March 26, 2013

Status Verified

March 1, 2008

Enrollment Period

3.8 years

First QC Date

October 20, 2005

Last Update Submit

March 25, 2013

Conditions

Head and Neck Cancer

Keywords

stage II squamous cell carcinoma of the hypopharynxstage II squamous cell carcinoma of the larynxstage III squamous cell carcinoma of the hypopharynxstage III squamous cell carcinoma of the larynx

Outcome Measures

Primary Outcomes (1)

  • Objective response of primary tumor

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Interventions

docetaxelDRUG
radiation therapyRADIATION

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (9)

Aichi Cancer Center

Nagoya, Aichi-ken, 464-8681, Japan

Location

Hirosaki University, School of Medicine

Hirosaki, Aomori, 036-8562, Japan

Location

Chiba University

Chiba, Chiba, 260-8677, Japan

Location

Yokohama City University

Yokohama, Kanagawa, 236-0004, Japan

Location

Shinshu University Health Center

Matsumoto, Nagano, 390-8621, Japan

Location

Nara Medical University Cancer Center

Nara, Nara, 634-8522, Japan

Location

Graduate School of Medical Science at the University of Ryukyu

Okinawa, Okinawa, 903-0215, Japan

Location

Hamamatsu University School of Medicine

Hamamatsu, Shizuoka, 431-31, Japan

Location

National Hospital Organization - Medical Center of Kure

Hiroshima, 737-0023, Japan

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and Neck

Interventions

DocetaxelRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesTherapeutics

Study Officials

  • Nobukazu Fuwa

    Aichi Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 20, 2005

First Posted

October 21, 2005

Study Start

June 1, 2004

Primary Completion

March 1, 2008

Study Completion

November 1, 2008

Last Updated

March 26, 2013

Record last verified: 2008-03

Locations

JP(9)