Head and Neck NeoplasmsPhase 2NCT00916097
NPC Study : TAX + CIS Neoadjuvant in Patients With Loco Regionally Advanced Undifferentiated Carcinoma of Nasopharyngeal Type (UCNT)
A Phase 2 study testing DOCETAXEL(XRP6976) in people with Head and Neck Neoplasms, run by Sanofi at 3 sites in 3 countries.
Trial summary
Primary Objective: To estimate the overall response rate after neo-adjuvant chemotherapy of Docetaxel 75 mg/m2 in combination with Cisplatin 75 mg/m2 given for 3 cycles, and followed by conventional radiotherapy in UCNT. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- DOCETAXEL(XRP6976)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jul 2002to Nov 2005
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written or witnessed oral informed consent prior to beginning specific protocol procedures >Histologically proven undifferentiated carcinoma of nasopharyngeal type (UCNT- stage II-III OMS) at first diagnosis
- Staging of disease: stage III, IV A, IV B (UICC/AJCC, 1997 classification), any T, N2 - N3 UCNT, without metastasis
- Adenopathy > 3 cm
- Patients are required to have an unidimensionally measurable disease with RECIST method
- Performance status 1 or karnofsky index 3
- Previous therapy: Chemotherapy :none Radiation therapy: none Surgery: none
- Laboratory requirements
Who cannot join
- Prior chemotherapy or / and radiotherapy
- Metastatic disease (M as per the UCCI/AJC classification)
- Past or current history of neoplasm other than UCNT, except for curatively treated non melanoma skin cancer or in situ carcinoma of the cervix or other cancer,curatively treated and with no evidence of disease at the previous 5 years
- Pregnant, or lacting, patients of childbearing potential must implement adequate contraceptive measures during study participation
- Pre-existing motor or sensory neurotoxicity of a severity 3 grade 2 according to NCI criteria
- Others serious illness or medical condition:
- 1.Congestive heart failure or unstable angina pectoris even if it is medically controlled 2.Previous history of myocardial infraction within 1 year from study entry 3.Uncontrolled hypertension or high risk uncontrolled arrhythmias 4.Uncontrolled peptic ulcer, unstable diabetes mellitus susceptible to contraindicate any use of corticoids 5.Concomitant treatment with corticoids initiated > 6 months prior to study entry is given to the dose of methylprednisolone or equivalent 3 20 mg 6.Definite contraindications for the use of Corticoids 7.Concurrent treatment with other experimental drugs 8.Participation in another clinical with any investigational drug within 30 days prior to study entry 9.Performance status = 2,3,4 or karnofsky index < 80 10. History of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent
- 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
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: A Multicenter Phase II Trial of Docetaxel Combined With Cisplatin (CDDP) as a Neo-Adjuvant Chemotherapy in Patients With Loco Regionally Advanced Undifferentiated Carcinoma of Nasopharyngeal Type (UCNT)
Primary Objective:
To estimate the overall response rate after neo-adjuvant chemotherapy of Docetaxel 75 mg/m2 in combination with Cisplatin 75 mg/m2 given for 3 cycles, and followed by conventional radiotherapy in UCNT.
Secondary Objectives:
To evaluate:
- The radiological response after chemotherapy and radiotherapy
- The pathological response after chemotherapy by cavum biopsy
To estimate:
- The duration of overall response
- The time to progression (T.T.P)
To analyze:
- The overall survival
- The safety profile
- Conditions
- Head and Neck Neoplasms
- Being tested
- DOCETAXEL(XRP6976)
- 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(XRP6976)Drug
docetaxel 75mg/m2 by intravenous infusion over 60 minutes on Day 1 of a 3-week cycle
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | docetaxel 75mg/m2 in combination with cisplatin 75mg/m2 given every 3 weeks for 3 cycles Receives: Drug: DOCETAXEL(XRP6976) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of tumor response in patients with measurable disease according to RECIST criteria
Measured: on day 21 of each treatment cycle for neoadjuvant chemotherapy, on day 64 and day 71 (3 to 4 weeks after the third chemotherapy)
Secondary outcomes (5)
Evaluation of the radiological response after chemotherapy and radiotherapy
Measured: from baseline to the end of the study
Evaluation of the pathological response after chemotherapy
Measured: between day 64 and day 71 of the treatment
Overall response duration
Measured: from baseline to the end of the study
Estimation of the time to progression
Measured: from baseline to the end of the study
Overall survival
Measured: from baseline to the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2009 (estimated)
- Study startJul 2002
- Primary completionNov 2005
- Study completionNov 2005
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Christian Fassotte, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00916097
- Sponsor's protocol ID
- XRP6976F_2502
- Status last verified
- Jun 2009
- First submitted
- 5 Jun 2009
- Last updated
- 24 Jun 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase II Trial of Docetaxel Combined With Cisplatin (CDDP) as a Neo-Adjuvant Chemotherapy in Patients With Loco Regionally Advanced Undifferentiated Carcinoma of Nasopharyngeal Type (UCNT)
- ClinicalTrials.gov ID
- NCT00916097
- Acronym / sponsor ID
- XRP6976F_2502
- Conditions
- Head and Neck Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jul 2002
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 9 Jun 2009 (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.
Primary Objective:
To estimate the overall response rate after neo-adjuvant chemotherapy of Docetaxel 75 mg/m2 in combination with Cisplatin 75 mg/m2 given for 3 cycles, and followed by conventional radiotherapy in UCNT.
Secondary Objectives:
To evaluate:
- The radiological response after chemotherapy and radiotherapy
- The pathological response after chemotherapy by cavum biopsy
To estimate:
- The duration of overall response
- The time to progression (T.T.P)
To analyze:
- The overall survival
- The safety profile
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(XRP6976)docetaxel 75mg/m2 in combination with cisplatin 75mg/m2 given every 3 weeks for 3 cycles |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written or witnessed oral informed consent prior to beginning specific protocol procedures >Histologically proven undifferentiated carcinoma of nasopharyngeal type (UCNT- stage II-III OMS) at first diagnosis
- Staging of disease: stage III, IV A, IV B (UICC/AJCC, 1997 classification), any T, N2 - N3 UCNT, without metastasis
- Adenopathy > 3 cm
- Patients are required to have an unidimensionally measurable disease with RECIST method
- Performance status 1 or karnofsky index 3
Key exclusion criteria (8 listed)
- Prior chemotherapy or / and radiotherapy
- Metastatic disease (M as per the UCCI/AJC classification)
- Past or current history of neoplasm other than UCNT, except for curatively treated non melanoma skin cancer or in situ carcinoma of the cervix or other cancer,curatively treated and with no evidence of disease at the previous 5 years
- Pregnant, or lacting, patients of childbearing potential must implement adequate contraceptive measures during study participation
- Pre-existing motor or sensory neurotoxicity of a severity 3 grade 2 according to NCI criteria
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(XRP6976)docetaxel 75mg/m2 by intravenous infusion over 60 minutes on Day 1 of a 3-week cycle | Drug | 1 |
Primary outcome
Evaluation of tumor response in patients with measurable disease according to RECIST criteria
Time frame: on day 21 of each treatment cycle for neoadjuvant chemotherapy, on day 64 and day 71 (3 to 4 weeks after the third chemotherapy)
5 secondary outcomes
Evaluation of the radiological response after chemotherapy and radiotherapy
Time frame: from baseline to the end of the study
Evaluation of the pathological response after chemotherapy
Time frame: between day 64 and day 71 of the treatment
Overall response duration
Time frame: from baseline to the end of the study
Estimation of the time to progression
Time frame: from baseline to the end of the study
Overall survival
Time frame: from baseline to the end of the study
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 24 Jun 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.
Christian Fassotte study director
Sanofi
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DOCETAXEL(XRP6976) in people with Head and Neck Neoplasms, run by Sanofi at 3 sites in 3 countries.
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 7 inclusion and 8 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 24 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Algeria, Morocco, Tunisia. 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?
Evaluation of tumor response in patients with measurable disease according to RECIST criteria (time frame: on day 21 of each treatment cycle for neoadjuvant chemotherapy, on day 64 and day 71 (3 to 4 weeks after the third chemotherapy)). 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 24 Jun 2009; AzTrials last refreshed its copy on 7 Nov 2026.