Head and Neck NeoplasmsPhase 2NCT00357149
Neoadjuvant Docetaxel Plus Cisplatin and 5-fluorouracil (TPF) Followed by Concomitant Chemoradiotherapy and Chemoradiotherapy Alone in Locally Advanced Squamous Cell Carcinoma of the Head and Neck Patients (SCCHNS)
A Phase 2 study testing Docetaxel, cisplatin and 5-FU treatment followed by concomitant cisplatin, 5-FU and radiotherapy and Concomitant cisplatin, 5-FU and radiotherapy in people with Head and Neck Neoplasms, run by Sanofi at 1 site in Italy.
Trial summary
To evaluate the rate of clinical complete response 6-8 weeks after treatment with docetaxel plus cisplatin and 5-fluorouracil followed by chemoradiotherapy and after chemoradiotherapy alone in patients with locally advanced squamous cell carcinoma of the head and neck. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- Docetaxel, cisplatin and 5-FU treatment followed by concomitant cisplatin, 5-FU and radiotherapy and Concomitant cisplatin, 5-FU and radiotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2003to Feb 2008
- 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 years and older
- 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.
- Primary tumor sites eligible: oral cavity, oropharynx, hypopharynx. Although they are admittedly of squamous cell types, the following tumors will be excluded because of theY responsiveness to chemotherapy: tumors of the nasal and paranasal cavities, larynx and of the nasopharynx.
- Stage III or IV disease without evidence of distant metastases verified by chest X Ray and/or lung CT scan, abdominal ultrasound, or CT (liver function test abnormalities); bone scan in case of local symptoms.
- At least one measurable lesion.
- Tumor considered inoperable after evaluation by a multidisciplinary team (i.e. a surgeon, a medical oncologist and a radiation oncologist).
- No previous chemotherapy or radiotherapy for any reason and no previous surgery for squamous cell carcinoma of the head and neck patients (other than biopsy) are allowed at time of study entry.
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- Karnofsky performance status ≥ 70.
- No active alcohol addiction.
- Adequate bone marrow, hepatic and renal functions
- Patients must be available for treatment and follow-up.
Who cannot join
- Pregnant or lactating women or women of childbearing potential not using adequate contraception.
- 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 ≥ grade 2
- Symptomatic altered hearing ≥ grade 2
- Other serious illnesses or medical conditions including:a) Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry.b) History of significant neurologic or psychiatric disorders including dementia or seizures.c) Active uncontrolled infection.d) Active peptic ulcer.e) Hypercalcemia.f) Chronic obstructive pulmonary disease requiring hospitalization during the year preceding study entry
- History of hypersensitivity reaction to polysorbate 80
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- Patients requiring intravenous alimentation.
- Patients who experienced a weight loss of more than 20% of their body weight in the 3 months preceding study entry.
- Concomitant treatment with any other anticancer therapy.
- Participation in a therapeutic clinical trial within 30 days of 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: Randomized Phase II Trial of Neoadjuvant Docetaxel Plus Cisplatin and 5-fluorouracil Followed by Concomitant Chemoradiotherapy and Chemoradiotherapy Alone in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck.
To evaluate the rate of clinical complete response 6-8 weeks after treatment with docetaxel plus cisplatin and 5-fluorouracil followed by chemoradiotherapy and after chemoradiotherapy alone in patients with locally advanced squamous cell carcinoma of the head and neck.
- Conditions
- Head and Neck Neoplasms
- Being tested
- Docetaxel, cisplatin and 5-FU treatment followed by concomitant cisplatin, 5-FU and radiotherapy, Concomitant cisplatin, 5-FU and radiotherapy
- 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, cisplatin and 5-FU treatment followed by concomitant cisplatin, 5-FU and radiotherapyDrug
Concomitant cisplatin, 5-FU and radiotherapyDrug
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Cisplatin from day 1 to day 4 and 5-FU for 4 days starting immediately after the end of cisplatin infusion on day 1. Both drugs were administered during week 1 and 6 of irradiation, starting from day 1 of weekly radiotherapy. Receives: Drug: Concomitant cisplatin, 5-FU and radiotherapy |
| B | Experimental | Docetaxel followed by cisplatin and 5-FU from day 1 to day 4 starting after the end of cisplatin infusion. The cycle was repeated every 3 weeks up to a total of 3 cycles. After 3-6 weeks from the end of neoadjuvant chemotherapy, patients will receive with the same modality of arm A (reference arm). Receives: Drug: Docetaxel, cisplatin and 5-FU treatment followed by concomitant cisplatin, 5-FU and radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of radiologic Complete Response (CR) evaluated 6-8 weeks after the completion of treatment
Measured: from end of treatment until 6-8 weeks
Secondary outcomes (4)
Duration of response
Measured: from the date of first documented tumor response to the date of first documented tumor progression
Time to disease progression
Measured: From the date of the treatment start to the date of first documented progression of disease
Time to treatment failure
Measured: from the date of treatment start to the date of diagnosis of progression, withdrawal from study treatment for any reason, administration of other antitumor treatment, or death for any cause
Median length of overall survival
Measured: time interval from the date of treatment to the date of death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2006 (estimated)
- Study startJan 2003
- Primary completionFeb 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Georges Paizis, MD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00357149
- Sponsor's protocol ID
- XRP6976F_2501
- Status last verified
- Dec 2009
- First submitted
- 26 Jul 2006
- Last updated
- 7 Dec 2009
- Results posted
- 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
- Randomized Phase II Trial of Neoadjuvant Docetaxel Plus Cisplatin and 5-fluorouracil Followed by Concomitant Chemoradiotherapy and Chemoradiotherapy Alone in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck.
- ClinicalTrials.gov ID
- NCT00357149
- Acronym / sponsor ID
- XRP6976F_2501
- Conditions
- Head and Neck Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Primary completion
- Feb 2008 (actual)
- First posted
- 27 Jul 2006 (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 evaluate the rate of clinical complete response 6-8 weeks after treatment with docetaxel plus cisplatin and 5-fluorouracil followed by chemoradiotherapy and after chemoradiotherapy alone in patients with locally advanced squamous cell carcinoma of the head and neck.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Concomitant cisplatin, 5-FU and radiotherapyCisplatin from day 1 to day 4 and 5-FU for 4 days starting immediately after the end of cisplatin infusion on day 1. Both drugs were administered during week 1 and 6 of irradiation, starting from day 1 of weekly radiotherapy. |
| B | Experimental | Drug: Docetaxel, cisplatin and 5-FU treatment followed by concomitant cisplatin, 5-FU and radiotherapyDocetaxel followed by cisplatin and 5-FU from day 1 to day 4 starting after the end of cisplatin infusion. The cycle was repeated every 3 weeks up to a total of 3 cycles. After 3-6 weeks from the end of neoadjuvant chemotherapy, patients will receive with the same modality of arm A (reference arm). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically or cytologically proven squamous cell carcinoma of the head and neck.
- Primary tumor sites eligible: oral cavity, oropharynx, hypopharynx. Although they are admittedly of squamous cell types, the following tumors will be excluded because of theY responsiveness to chemotherapy: tumors of the nasal and paranasal cavities, larynx and of the nasopharynx.
- Stage III or IV disease without evidence of distant metastases verified by chest X Ray and/or lung CT scan, abdominal ultrasound, or CT (liver function test abnormalities); bone scan in case of local symptoms.
- At least one measurable lesion.
- Tumor considered inoperable after evaluation by a multidisciplinary team (i.e. a surgeon, a medical oncologist and a radiation oncologist).
Key exclusion criteria (11 listed)
- Pregnant or lactating women or women of childbearing potential not using adequate contraception.
- 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 ≥ grade 2
- Symptomatic altered hearing ≥ grade 2
- Other serious illnesses or medical conditions including:a) Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry.b) History of significant neurologic or psychiatric disorders including dementia or seizures.c) Active uncontrolled infection.d) Active peptic ulcer.e) Hypercalcemia.f) Chronic obstructive pulmonary disease requiring hospitalization during the year preceding study entry
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, cisplatin and 5-FU treatment followed by concomitant cisplatin, 5-FU and radiotherapy | Drug | B |
| Concomitant cisplatin, 5-FU and radiotherapy | Drug | A |
Primary outcome
Rate of radiologic Complete Response (CR) evaluated 6-8 weeks after the completion of treatment
Time frame: from end of treatment until 6-8 weeks
4 secondary outcomes
Duration of response
Time frame: from the date of first documented tumor response to the date of first documented tumor progression
Time to disease progression
Time frame: From the date of the treatment start to the date of first documented progression of disease
Time to treatment failure
Time frame: from the date of treatment start to the date of diagnosis of progression, withdrawal from study treatment for any reason, administration of other antitumor treatment, or death for any cause
Median length of overall survival
Time frame: time interval from the date of treatment to the date of death
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.
Georges Paizis, 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 2 study testing Docetaxel, cisplatin and 5-FU treatment followed by concomitant cisplatin, 5-FU and radiotherapy and Concomitant cisplatin, 5-FU and radiotherapy in people with Head and Neck Neoplasms, run by Sanofi at 1 site in Italy.
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 10 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 Italy. 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?
Rate of radiologic Complete Response (CR) evaluated 6-8 weeks after the completion of treatment (time frame: from end of treatment until 6-8 weeks). 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.