Head and Neck CancerPhase 2NCT00093665
Fluorouracil, Cisplatin, and Radiation Therapy in Treating Patients With Stage II, Stage III, or Stage IV Nasopharyngeal Cancer
A Phase 2 study testing cisplatin, fluorouracil and radiation therapy in people with Head and Neck Cancer, run by Aichi Cancer Center at 7 sites in Japan.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining fluorouracil and cisplatin with radiation therapy may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- cisplatin, fluorouracil and radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 7 sitesJapan
- Study dates
- Nov 2003to not given
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed nasopharyngeal cancer (NPC)
- Type I-III disease by WHO classification
- Stage IIB-IVB disease by TNM classification with no distant metastases by chest x-ray, liver ultrasonography or CT scan, and bone scintigraphy
- Lymph node metastases evaluated by CT scan, MRI, and palpation
- Progression range of primary lesion evaluated by MRI and pharyngeal fiberoptic endoscopy
PATIENT CHARACTERISTICS:
Age
- 18 to 70
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- WBC > 3,500/mm^3
- Platelet count > 100,000/mm^3
Hepatic
- No severe hepatic dysfunction
Renal
- Creatinine clearance > 60 mL/min
- No severe renal dysfunction
Cardiovascular
- No severe cardiac dysfunction
Pulmonary
- No severe pulmonary dysfunction
Other
- No other active cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior biologic therapy for NPC
Chemotherapy
- No prior systemic chemotherapy for NPC
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Japan7 sites
National Hospital Organization - Medical Center of Kure
Hiroshima, 737-0023
Kanazawa University
Kanazawa, 920-8641
Kyoto Prefectural University of Medicine
Kyoto, 602
Aichi Cancer Center
Nagoya, 464-8681
Nara Medical University Cancer Center
Nara, 634-8522
Graduate School of Medical Science at the University of Ryukyu
Okinawa, 903-0215
Mie University School of Medicine
Tsu, 514-8507
About this study
Official title: A Phase II Study Of Alternating Chemoradiotherapy For Nasopharyngeal Cancer Using Cisplatin And 5-Fluorouracil
RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining fluorouracil and cisplatin with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving fluorouracil and cisplatin together with radiation therapy works in treating patients with stage II, stage III, or stage IV nasopharyngeal cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine progression-free survival of patients with previously untreated stage IIB-IVB nasopharyngeal cancer treated with fluorouracil, cisplatin, and radiotherapy.
Secondary
- Determine overall survival and response rate in patients treated with this regimen.
- Determine compliance to this regimen in these patients.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive chemotherapy comprising fluorouracil IV continuously on days 1-5 and cisplatin IV continuously on days 6-7. Beginning 2-3 days after the completion of chemotherapy, patients undergo radiotherapy once daily, 5 days a week, for 4 weeks. With 2-3 days between each course, patients receive a second course of chemotherapy, undergo a second course of radiotherapy, and then receive a third course of chemotherapy. Treatment continues in the absence of unacceptable toxicity or disease progression.
Patients are followed for 3 years.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 2 years.
- Conditions
- Head and Neck Cancer
- Being tested
- cisplatin, fluorouracil, radiation therapy
- Keywords
- stage II lymphoepithelioma of the nasopharynx, stage III lymphoepithelioma of the nasopharynx, stage IV lymphoepithelioma of the nasopharynx, stage II squamous cell carcinoma of the nasopharynx, stage III squamous cell carcinoma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatinDrug
fluorouracilDrug
radiation therapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival at 3 years
Secondary outcomes (4)
Overall survival
Response rate
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 posted8 Oct 2004 (estimated)
- Study startNov 2003
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
- 90 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
- NCT00093665
- Sponsor's protocol ID
- AICHI-UHA-HN03-01
- Other IDs
- CDR0000389425
- Status last verified
- Oct 2006
- First submitted
- 6 Oct 2004
- Last updated
- 15 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Of Alternating Chemoradiotherapy For Nasopharyngeal Cancer Using Cisplatin And 5-Fluorouracil
- ClinicalTrials.gov ID
- NCT00093665
- Acronym / sponsor ID
- AICHI-UHA-HN03-01
- Conditions
- Head and Neck Cancer
- Keywords
- stage II lymphoepithelioma of the nasopharynx, stage III lymphoepithelioma of the nasopharynx, stage IV lymphoepithelioma of the nasopharynx, stage II squamous cell carcinoma of the nasopharynx, stage III squamous cell carcinoma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Aichi Cancer CenterUniversity, hospital or other
- Study start
- Nov 2003
- First posted
- 8 Oct 2004 (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 fluorouracil and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining fluorouracil and cisplatin with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving fluorouracil and cisplatin together with radiation therapy works in treating patients with stage II, stage III, or stage IV nasopharyngeal cancer.
Detailed description
OBJECTIVES:
Primary
- Determine progression-free survival of patients with previously untreated stage IIB-IVB nasopharyngeal cancer treated with fluorouracil, cisplatin, and radiotherapy.
Secondary
- Determine overall survival and response rate in patients treated with this regimen.
- Determine compliance to this regimen in these patients.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive chemotherapy comprising fluorouracil IV continuously on days 1-5 and cisplatin IV continuously on days 6-7. Beginning 2-3 days after the completion of chemotherapy, patients undergo radiotherapy once daily, 5 days a week, for 4 weeks. With 2-3 days between each course, patients receive a second course of chemotherapy, undergo a second course of radiotherapy, and then receive a third course of chemotherapy. Treatment continues in the absence of unacceptable toxicity or disease progression.
Patients are followed for 3 years.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 2 years.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| cisplatin | Drug | – |
| fluorouracil | Drug | – |
| radiation therapy | Radiation | – |
Primary outcome
Progression-free survival at 3 years
4 secondary outcomes
Overall survival
Response rate
Treatment completion rate
Incidence of adverse effects
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 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
7 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 cisplatin, fluorouracil and radiation therapy in people with Head and Neck Cancer, run by Aichi Cancer Center at 7 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Results are not available in the source record.
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?
Progression-free survival at 3 years. 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 15 May 2013.