Carcinoma, Squamous CellPhase 3NCT00539630
TAX + Cisplatin + 5 F/U vs Cisplatin + 5 F/U in SCCHN
A Phase 3 study testing Docetaxel in people with Carcinoma, Squamous Cell, run by Sanofi at 1 site in South Korea.
Trial summary
To describe the clinical response rate in two groups (Docetaxel plus cisplatin plus 5-FU, versus Cisplatin plus 5-FU) after 3 cycle of neoadjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Carcinoma, Squamous Cell
- What is being tested?
- Docetaxel
- How many people
- 86 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2002to not given
- Phase
- Phase 3
- 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
Who may be able to join
- Histologically or cytologically proven squamous cell carcinoma of the head and neck with locally advanced inoperable disease.
- Primary tumor sites eligible: oral cavity, oropharynx, hypopharynx , larynx or nasopharynx.
- Patients are required to have at least one (bi-or uni-dimensionally) measurable lesion.
- WHO performance status 0 or 1.
- Adequate bone marrow, hepatic and renal functions.
Who cannot join
- Pregnant and lactating women
- Previous chemotherapy
- Previous radiotherapy for H\&N
- Previous surgery for H\&N
- 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
To describe the clinical response rate in two groups (Docetaxel plus cisplatin plus 5-FU, versus Cisplatin plus 5-FU) after 3 cycle of neoadjuvant chemotherapy.
- Conditions
- Carcinoma, Squamous Cell
- Being tested
- Docetaxel
- Medical subject headings
- Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response will be evaluated by modified WHO criteria. Clinical and radiological assessment of all lesions will be performed
Measured: After 2 cycle, 3 cycle and after concurrent chemo/radiotherapy.
Secondary outcomes (1)
Pathologic response if clinical response of primary tumor is CR at the end of chemotherapy and end of concurrent chemo/ radiotherapy, biopsy of primary tumor site will be performed to evaluate pathologic response rate.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2007 (estimated)
- Study startNov 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Squamous CellStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Hyang Rim Kim, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00539630
- Sponsor's protocol ID
- XRP6976F_3501
- Status last verified
- Oct 2007
- First submitted
- 3 Oct 2007
- Last updated
- 4 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TAX + Cisplatin + 5 F/U vs Cisplatin + 5 F/U in SCCHN
- ClinicalTrials.gov ID
- NCT00539630
- Acronym / sponsor ID
- XRP6976F_3501
- Conditions
- Carcinoma, Squamous Cell
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- First posted
- 4 Oct 2007 (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 describe the clinical response rate in two groups (Docetaxel plus cisplatin plus 5-FU, versus Cisplatin plus 5-FU) after 3 cycle of neoadjuvant chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically or cytologically proven squamous cell carcinoma of the head and neck with locally advanced inoperable disease.
- Primary tumor sites eligible: oral cavity, oropharynx, hypopharynx , larynx or nasopharynx.
- Patients are required to have at least one (bi-or uni-dimensionally) measurable lesion.
- WHO performance status 0 or 1.
- Adequate bone marrow, hepatic and renal functions.
Key exclusion criteria (5 listed)
- Pregnant and lactating women
- Previous chemotherapy
- Previous radiotherapy for H\&N
- Previous surgery for H\&N
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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 | – |
Primary outcome
Clinical response will be evaluated by modified WHO criteria. Clinical and radiological assessment of all lesions will be performed
Time frame: After 2 cycle, 3 cycle and after concurrent chemo/radiotherapy.
1 secondary outcome
Pathologic response if clinical response of primary tumor is CR at the end of chemotherapy and end of concurrent chemo/ radiotherapy, biopsy of primary tumor site will be performed to evaluate pathologic response rate.
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 4 Oct 2007.
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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.
Hyang Rim Kim 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 3 study testing Docetaxel in people with Carcinoma, Squamous Cell, run by Sanofi at 1 site in South Korea.
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 5 inclusion and 5 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 4 Oct 2007. 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 South Korea. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Clinical response will be evaluated by modified WHO criteria. Clinical and radiological assessment of all lesions will be performed (time frame: After 2 cycle, 3 cycle and after concurrent chemo/radiotherapy.). 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 4 Oct 2007.