Head and Neck CancerPhase 2NCT00243113
Docetaxel and Radiation Therapy in Treating Patients With Stage II or Stage III Cancer of the Larynx or Hypopharynx
A Phase 2 study testing docetaxel and radiation therapy in people with Head and Neck Cancer, run by Aichi Cancer Center at 9 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- docetaxel and radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 9 sitesJapan
- Study dates
- Jun 2004to Nov 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Japan9 sites
Chiba University
Chiba, Chiba, 260-8677
Hamamatsu University School of Medicine
Hamamatsu, Shizuoka, 431-31
Hirosaki University, School of Medicine
Hirosaki, Aomori, 036-8562
National Hospital Organization - Medical Center of Kure
Hiroshima, 737-0023
Shinshu University Health Center
Matsumoto, Nagano, 390-8621
Aichi Cancer Center
Nagoya, Aichi-ken, 464-8681
Nara Medical University Cancer Center
Nara, Nara, 634-8522
Graduate School of Medical Science at the University of Ryukyu
Okinawa, Okinawa, 903-0215
Yokohama City University
Yokohama, Kanagawa, 236-0004
About this study
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
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.
Read the 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.
- Conditions
- Head and Neck Cancer
- Being tested
- docetaxel, radiation therapy
- 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
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxelDrug
radiation therapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Treatment completion rate
Incidence of adverse effects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2005 (estimated)
- Study startJun 2004
- Primary completionMar 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aichi Cancer Center
- Sponsor type
- University, hospital or other
- Investigators
- Nobukazu Fuwa, Study chair, Aichi Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00243113
- Sponsor's protocol ID
- CDR0000439499
- Other IDs
- AICHI-UHA-HN04-02
- Status last verified
- Mar 2008
- First submitted
- 20 Oct 2005
- Last updated
- 26 Mar 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00243113
- Acronym / sponsor ID
- CDR0000439499
- Conditions
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Aichi Cancer CenterUniversity, hospital or other
- Study start
- Jun 2004
- Primary completion
- Mar 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 21 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| docetaxel | Drug | – |
| radiation therapy | Radiation | – |
Primary outcome
Objective response of primary tumor
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nobukazu Fuwa study chair
Aichi Cancer Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing docetaxel and radiation therapy in people with Head and Neck Cancer, run by Aichi Cancer Center at 9 sites in Japan.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response of primary tumor. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2013.