Head and Neck NeoplasmsPhase 3NCT00995293
Taxotere (Docetaxel) New Indication: Squamous Cell Carcinoma of the Head and Neck (SCCHN) Treatment Registration Trial
A Phase 3 study testing DOCETAXEL, CISPLATIN and 5-FLUOROURACIL in people with Head and Neck Neoplasms, run by Sanofi at 1 site in China.
Trial summary
The Primary Objective is to evaluate the progression-free survival after treatment with docetaxel plus cisplatin plus 5-Fluorouracil (5-FU) (DCF) in comparison with cisplatin plus 5-FU (CF) in patient with locally advanced inoperable SCCHN The Secondary Objective is to evaluate and compare the clinical response rate… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- DOCETAXEL, CISPLATIN and 5-FLUOROURACIL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 27 Aug 2009to 26 Jan 2018
- 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
- Tumor type: Histologically or cytologically proven squamous cell carcinoma of the head and neck (SCCHN) presenting with locally advanced disease at diagnosis. Primary tumor sites eligible are: oral cavity, oropharynx, hypopharynx and larynx.
- Extent of the disease:
- Patients are required to have at least one measurable lesion.
- Stage III or IV without evidence of distant metastases, according to the TNM staging system. Absence of metastases must be checked by chest X-ray (with or without Computed tomography (CT) ), abdominal ultrasound or CT in case of liver function test abnormalities, and bone scan in case of local symptoms.
- Tumor considered as inoperable after evaluation by a multidisciplinary team. Reason for inoperability will be reported in the CRF
- World Health Organization (WHO) performance status 0 or 1
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- Laboratory data:
- Haematology:
- Neutrophil count > or = 2.0*10^9/L
- Platelet count > or = 100*10^9/L
- Hemoglobin > or = 10 g/dl (6.2 mmol/L)
- Hepatic function:
- Total serum bilirubin < or = 1 time the upper normal limit (UNL) of the participating center
- Aspartate transaminase (ASAT/SGOT) and Alanine transaminase (ALAT/SGPT) < or = 2.5UNL
- Alkaline phosphatase < or = 5 UNL
- Patients with ASAT or ALAT > 1.5UNL associated with alkaline phosphatase >2.5UNL are not eligible for the study
- Renal function:
- serum creatinine < or = 120µmol/L (1.4 mg/dl) if values are >120µmol/L, creatinine clearance should be > or = 60 ml/min
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, those conditions should be discussed with the patient before registration in the trial
- Patients informed consent form obtained
Who cannot join
- Tumors of the nasopharynx, the nasal and paranasal cavities.
- Previous chemotherapy or radiotherapy for any reason and previous surgery for SCCHN at time of study entry.
- Prior treatment within a therapeutic clinical tria within 30 days prior to study entry
- Concurrent treatment with any other anticancer therapy
- Chronic treatment (> or = 3 months) with corticosteroids at a daily dose > or = 20mg methylprednisolone or equivalent.
- Concomitant use of drugs which could interact with 5-fluorouracil (e.g. cimetidine, allopurinol, folic or folinic acid, methotrexate and metronidazole)
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- Previous or current malignancies at other sites with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma of the skin or other cancer curatively treated by surgery and with no evidence of disease for at least 5 years
- Symptomatic peripheral neuropathy > or = grade 2 by NCIC-CTG criteria
- Clinical altered hearing
- Pregnant, lactating women or of childbearing potential unless adequate
- with other serious illness or medical condition including but not limited to:
- unstable cardiac disease despite treatment
- myocardial infarction within 6 months prior to study entry
- history of significant neurologic or psychiatric disorders including dementia or seizures
- active uncontrolled infection
- active peptic ulcer
- chronic obstructive pulmonary disease requiring hospitalization during the year preceding study entry
- 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: An Open-label, Randomized, Parallel-group, Multicenter Study of Neoadjuvant Docetaxel(Taxotere®) Plus Cisplatin Plus 5-fluorouracil Versus Neoadjuvant Cisplatin Plus 5-fluorouracil in Patients With Locally Advanced Inoperable Squamous Cell Carcinoma of the Head and Neck
The Primary Objective is to evaluate the progression-free survival after treatment with docetaxel plus cisplatin plus 5-Fluorouracil (5-FU) (DCF) in comparison with cisplatin plus 5-FU (CF) in patient with locally advanced inoperable SCCHN The Secondary Objective is to evaluate and compare the clinical response rate both before and after radiotherapy, the local symptoms, the duration of response, the time to treatment failure, the survival, the toxicity and the quality of life in the 2 study groups.
- Conditions
- Head and Neck Neoplasms
- Being tested
- DOCETAXEL, CISPLATIN, 5-FLUOROURACIL
- 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.
DOCETAXELDrug
Intravenous
CISPLATINDrug
Intravenous
5-FLUOROURACILDrug
Intravenous
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel Cisplatin 5-Fluorouracil (DCF) | Experimental | 4 cycles of the following products every 3 weeks (unless disease progression/relapse or unacceptable toxicity occured or the patient refused treatment):
* Docetaxel 60mg/m² on day 1
* Cisplatin 75mg/m² on day 1
* 5-FU 750mg/m²/day on day 1 to day 5 Receives: Drug: DOCETAXEL; Drug: CISPLATIN; Drug: 5-FLUOROURACIL |
| Cisplatin 5-Fluorouracil (CF) | Experimental | 4 cycles of the following products every 3 weeks (unless disease progression/relapse or unacceptable toxicity occured or the patient refused treatment):
* Cisplatin 75mg/m² on day 1
* 5-FU 750mg/m²/day on day 1 to day 5 Receives: Drug: CISPLATIN; Drug: 5-FLUOROURACIL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: From randomization to any progression event or patient death (follow-up every 3 months 1st year, then every 6 months)
Secondary outcomes (4)
Overall survival
Measured: From randomization to patient death (follow-up every 3 months 1st year, then every 6 months)
Overall response rates
Measured: From randomization to any progression event or patient death (follow-up every 3 months 1st year, then every 6 months) and at the end of chemotherapy + end of radiotherapy
Duration of response
Measured: From randomization to any progression event or patient death (follow-up every 3 months 1st year, then every 6 months)
Time to treatment failure
Measured: From randomization to any progression event or patient death (follow-up every 3 months 1st year, then every 6 months) and at the end of chemotherapy + end of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2009 (estimated)
- Study start27 Aug 2009
- Primary completion26 Jan 2018
- Study completion26 Jan 2018
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mo Chen, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00995293
- Sponsor's protocol ID
- DOCET_L_02557
- Status last verified
- Mar 2018
- First submitted
- 22 Sep 2009
- Last updated
- 2 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Parallel-group, Multicenter Study of Neoadjuvant Docetaxel(Taxotere®) Plus Cisplatin Plus 5-fluorouracil Versus Neoadjuvant Cisplatin Plus 5-fluorouracil in Patients With Locally Advanced Inoperable Squamous Cell Carcinoma of the Head and Neck
- ClinicalTrials.gov ID
- NCT00995293
- Acronym / sponsor ID
- DOCET_L_02557
- Conditions
- Head and Neck Neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 27 Aug 2009 (actual)
- Primary completion
- 26 Jan 2018 (actual)
- Study completion
- 26 Jan 2018 (actual)
- First posted
- 15 Oct 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.
The Primary Objective is to evaluate the progression-free survival after treatment with docetaxel plus cisplatin plus 5-Fluorouracil (5-FU) (DCF) in comparison with cisplatin plus 5-FU (CF) in patient with locally advanced inoperable SCCHN The Secondary Objective is to evaluate and compare the clinical response rate both before and after radiotherapy, the local symptoms, the duration of response, the time to treatment failure, the survival, the toxicity and the quality of life in the 2 study groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Docetaxel Cisplatin 5-Fluorouracil (DCF) | Experimental | Drug: DOCETAXEL, Drug: CISPLATIN, Drug: 5-FLUOROURACIL4 cycles of the following products every 3 weeks (unless disease progression/relapse or unacceptable toxicity occured or the patient refused treatment): * Docetaxel 60mg/m² on day 1 * Cisplatin 75mg/m² on day 1 * 5-FU 750mg/m²/day on day 1 to day 5 |
| Cisplatin 5-Fluorouracil (CF) | Experimental | Drug: CISPLATIN, Drug: 5-FLUOROURACIL4 cycles of the following products every 3 weeks (unless disease progression/relapse or unacceptable toxicity occured or the patient refused treatment): * Cisplatin 75mg/m² on day 1 * 5-FU 750mg/m²/day on day 1 to day 5 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Tumor type: Histologically or cytologically proven squamous cell carcinoma of the head and neck (SCCHN) presenting with locally advanced disease at diagnosis. Primary tumor sites eligible are: oral cavity, oropharynx, hypopharynx and larynx.
- Extent of the disease:
- World Health Organization (WHO) performance status 0 or 1
- Laboratory data:
- Neutrophil count > or = 2.0*10^9/L
Key exclusion criteria (18 listed)
- Tumors of the nasopharynx, the nasal and paranasal cavities.
- Previous chemotherapy or radiotherapy for any reason and previous surgery for SCCHN at time of study entry.
- Prior treatment within a therapeutic clinical tria within 30 days prior to study entry
- Concurrent treatment with any other anticancer therapy
- Chronic treatment (> or = 3 months) with corticosteroids at a daily dose > or = 20mg methylprednisolone or equivalent.
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 |
|---|---|---|
| DOCETAXELIntravenous | Drug | Docetaxel Cisplatin 5-Fluorouracil (DCF) |
| CISPLATINIntravenous | Drug | Cisplatin 5-Fluorouracil (CF), Docetaxel Cisplatin 5-Fluorouracil (DCF) |
| 5-FLUOROURACILIntravenous | Drug | Cisplatin 5-Fluorouracil (CF), Docetaxel Cisplatin 5-Fluorouracil (DCF) |
Primary outcome
Progression-free survival
Time frame: From randomization to any progression event or patient death (follow-up every 3 months 1st year, then every 6 months)
4 secondary outcomes
Overall survival
Time frame: From randomization to patient death (follow-up every 3 months 1st year, then every 6 months)
Overall response rates
Time frame: From randomization to any progression event or patient death (follow-up every 3 months 1st year, then every 6 months) and at the end of chemotherapy + end of radiotherapy
Duration of response
Time frame: From randomization to any progression event or patient death (follow-up every 3 months 1st year, then every 6 months)
Time to treatment failure
Time frame: From randomization to any progression event or patient death (follow-up every 3 months 1st year, then every 6 months) and at the end of chemotherapy + end of radiotherapy
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 2 Mar 2018.
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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.
Mo Chen 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, CISPLATIN and 5-FLUOROURACIL in people with Head and Neck Neoplasms, run by Sanofi at 1 site in China.
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 20 inclusion and 18 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 2 Mar 2018. 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 China. 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?
Progression-free survival (time frame: From randomization to any progression event or patient death (follow-up every 3 months 1st year, then every 6 months)). 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 2 Mar 2018.