Head and Neck NeoplasmsPhase 4Tax-NazoNCT00772681
Efficacy of Chemoradiotherapy After Neoadjuvant Cisplatin and Docetaxel in the Nasopharynx Carcinoma
A Phase 4 study testing docetaxel and cisplatin in people with Head and Neck Neoplasms, run by Sanofi at 1 site in Turkey (Türkiye).
Trial summary
To assess the efficacy of docetaxel, cisplatin combination in terms of disease free survival. Time to progression of the disease in terms of local and distant failure; assess the survival time, and assess the objective (clinical and radiological) response rate and the safety of the treatment. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- docetaxel and cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2004to Mar 2008
- Phase
- Phase 4
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically/cytologically confirmed, patients with stage T2b-T4N1 or TanyN2-3 undifferentiated or nonkeratinized squamous cell carcinoma of nasopharynx who are candidate for curative radiotherapy.
- ECOG Performance Status is 0-1
- Weight loss within last 6 months <10% of body weight
- Acceptable haematological profile (as defined by a leukocyte count ≥ 4000/mm3, a platelet count ≥ 100.000mm3 and Hb ≥ 9g/100mL), and adequate renal function (as defined by serum creatinine ≤ 1.5mg/dl), and hepatic function (as defined by bilirubin ≤ 1.5 x maximum normal value even with hepatic metastasis; transaminases (ALT, AST) ≤ 1.5 x maximum normal value; alkaline phosphatase ≤ 2.5 x maximum normal value, except in case of a bone metastasis)
Who cannot join
- Patients with stage IVC or metastatic disease
- Patients treated with chemotherapy for nasopharyngeal cancer
- Patients treated with radiotherapy to head and neck region
- Concomitant use of another anti-cancer therapy
- Patients treated with amifostine or pilocarpine during protocol treatment.
- Unstable medical condition that makes the patient unable to take part in a clinical study (congestive heart failure, serious arrhythmia, uncontrolled diabetes mellitus), history of myocardial infarction within last 6 months, massive pleural, peritoneal or pericardial effusion; or presence of serious uncontrolled infection.
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- Presence of other tumours different from carcinoma of the skin except melanoma and carcinoma in situ of the breast and cervix with disease free survival less than 5 years.
- Pregnancy or breastfeeding. In women of childbearing potential and in men, an adequate contraceptive method must be used
- Social or psychological condition that render the patient inadequate for the follow-up of the study
- Contraindication for any of the study drugs (e.g. history of hypersensitivity to any of the ingredients of the study drugs)
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IV Clinical Study Evaluating The Efficacy of Chemoradiotherapy Following Neoadjuvant Treatment With Docetaxel and Cisplatin in Indifferentiated and Non-keratinized Squamous Cell Carcinoma of Nasopharynx
- To assess the efficacy of docetaxel, cisplatin combination in terms of disease free survival.
- Time to progression of the disease in terms of local and distant failure; assess the survival time, and assess the objective (clinical and radiological) response rate and the safety of the treatment.
- Conditions
- Head and Neck Neoplasms
- Being tested
- docetaxel and cisplatin
- 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.
docetaxel and cisplatinDrug
3 cycles of docetaxel 75mg/m2 and 100mg/m2 cisplatin combination every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: docetaxel and cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate after neoadjuvant chemotherapy
Measured: From the start date of the treatment to the date of first documented progression of disease or at least until 2 years follow-up period
Secondary outcomes (4)
Percentage of patients whose is disease controlled locally or regionally
Measured: from the start date of the treatment to the date of first documented local or regional tumor progression
Median length of overall survival
Measured: time interval from the date of treatment to the date of death or at least until 2 years follow-up period
Median length of disease free survival
Measured: time interval from the date of treatment to the date of death or at least until 2 years follow-up period
Percentage of alive patients without metastatis
Measured: from the start date of the treatment to the date of first documented distant metastasis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2008 (estimated)
- Study startOct 2004
- Primary completionMar 2008
- Study completionMar 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 NeoplasmsStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Edibe Taylan, MD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00772681
- Sponsor's protocol ID
- XRP6976F_6007
- Acronym
- Tax-Nazo
- Status last verified
- Dec 2009
- First submitted
- 13 Oct 2008
- Last updated
- 7 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Clinical Study Evaluating The Efficacy of Chemoradiotherapy Following Neoadjuvant Treatment With Docetaxel and Cisplatin in Indifferentiated and Non-keratinized Squamous Cell Carcinoma of Nasopharynx
- ClinicalTrials.gov ID
- NCT00772681
- Acronym / sponsor ID
- Tax-Nazo / XRP6976F_6007
- Conditions
- Head and Neck Neoplasms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 15 Oct 2008 (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.
- To assess the efficacy of docetaxel, cisplatin combination in terms of disease free survival.
- Time to progression of the disease in terms of local and distant failure; assess the survival time, and assess the objective (clinical and radiological) response rate and the safety of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: docetaxel and cisplatin |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically/cytologically confirmed, patients with stage T2b-T4N1 or TanyN2-3 undifferentiated or nonkeratinized squamous cell carcinoma of nasopharynx who are candidate for curative radiotherapy.
- ECOG Performance Status is 0-1
- Weight loss within last 6 months <10% of body weight
- Acceptable haematological profile (as defined by a leukocyte count ≥ 4000/mm3, a platelet count ≥ 100.000mm3 and Hb ≥ 9g/100mL), and adequate renal function (as defined by serum creatinine ≤ 1.5mg/dl), and hepatic function (as defined by bilirubin ≤ 1.5 x maximum normal value even with hepatic metastasis; transaminases (ALT, AST) ≤ 1.5 x maximum normal value; alkaline phosphatase ≤ 2.5 x maximum normal value, except in case of a bone metastasis)
Key exclusion criteria (11 listed)
- Patients with stage IVC or metastatic disease
- Patients treated with chemotherapy for nasopharyngeal cancer
- Patients treated with radiotherapy to head and neck region
- Concomitant use of another anti-cancer therapy
- Patients treated with amifostine or pilocarpine during protocol treatment.
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 and cisplatin3 cycles of docetaxel 75mg/m2 and 100mg/m2 cisplatin combination every 3 weeks | Drug | 1 |
Primary outcome
Complete response rate after neoadjuvant chemotherapy
Time frame: From the start date of the treatment to the date of first documented progression of disease or at least until 2 years follow-up period
4 secondary outcomes
Percentage of patients whose is disease controlled locally or regionally
Time frame: from the start date of the treatment to the date of first documented local or regional tumor progression
Median length of overall survival
Time frame: time interval from the date of treatment to the date of death or at least until 2 years follow-up period
Median length of disease free survival
Time frame: time interval from the date of treatment to the date of death or at least until 2 years follow-up period
Percentage of alive patients without metastatis
Time frame: from the start date of the treatment to the date of first documented distant metastasis
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 7 Dec 2009.
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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.
Edibe Taylan, MD study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing docetaxel and cisplatin in people with Head and Neck Neoplasms, run by Sanofi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. 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: finished, as of the sponsor's last update on 7 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Complete response rate after neoadjuvant chemotherapy (time frame: From the start date of the treatment to the date of first documented progression of disease or at least until 2 years follow-up period). 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 7 Dec 2009.