Squamous Cell Carcinoma of Head and NeckPhase 2DECIDENCT02061631
Study to Evaluate the Response Rate to Therapy With Docetaxel and Cisplatin in Unresectable Locally Advanced Squamous Cell Carcinoma of Head and Neck
A Phase 2 study testing Cisplatin, DOCETAXEL XRP6976 and Dexamethasone in people with Squamous Cell Carcinoma of Head and Neck, run by Sanofi at 1 site in Pakistan.
Trial summary
Primary Objective: To evaluate the overall response rate (including complete response and partial response) of subjects treated with combination therapy docetaxel and cisplatin followed by the chemoradiotherapy in patients with locally advanced head and neck cancer Secondary Objective: To assess the safety and… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Squamous Cell Carcinoma of Head and Neck
- What is being tested?
- Cisplatin, DOCETAXEL XRP6976 and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 sitePakistan
- Study dates
- May 2014to Oct 2015
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Histologically confirmed, unresectable locally advanced squamous cell carcinoma of head and neck of oral cavity in stage III-IV without evidence of distant metastases.
- No prior chemotherapy or radiation therapy.
- Having at least one measurable lesion in one dimension.
- Age ≥18 and <65 years with Eastern Cooperative Oncology Group ≤ 1.
- Adequate organ function:
- Adequate hematological function
- Adequate hepatic function
- Renal function within normal limits
Who cannot join
- Peripheral neuropathy > grade 1 or other serious diseases (unstable ischaemic heart disease, acute myocardial infarction six months prior to inclusion, history of significant neurological or psychiatric disorder or active peptic ulcer).
- Being treated concomitantly with corticosteroids (except as pre-medication).
- Patients having another type of cancer.
- Previous chemotherapy or radiotherapy.
- Any previous definitive surgery for squamous cell carcinoma of head and neck.
- Severe weight loss (> 20 % of body weight) in the preceding 3 months.
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- Hearing loss (> grade 2).
- Pregnancy (pregnancy test result for women of childbearing potential).
- Sexually active females with lack of adequate contraception.
- 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: Open Label, Non Controlled, Non Randomized, Interventional Study to Evaluate the Response Rate After Induction Therapy With DocEtaxel and CIsplatin in Unresectable Locally Advanced Squamous Cell Carcinoma of heaD and nEck
Primary Objective:
To evaluate the overall response rate (including complete response and partial response) of subjects treated with combination therapy docetaxel and cisplatin followed by the chemoradiotherapy in patients with locally advanced head and neck cancer
Secondary Objective:
To assess the safety and tolerability of combination therapy docetaxel and cisplatin followed by the chemoradiotherapy in patients with locally advanced head and neck cancer
Read the detailed description
The treatment duration for each patient will be around six months. Patients included in the study will be treated with induction regimen followed by chemo radiotherapy. Within the induction period there are three cycles (Docetaxel + Cisplatin) every 21 days, with follow-up post-induction at day 21 after cycle three. This is followed by chemoradiotherapy consisting of radiotherapy for six weeks and cisplatin every week for four weeks. The post-consolidation follow up is at eight weeks after end of chemoradiotherapy.
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Being tested
- Cisplatin, DOCETAXEL XRP6976, Dexamethasone
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
Pharmaceutical form:solution Route of administration: intravenous
DOCETAXEL XRP6976Drug
Pharmaceutical form:solution Route of administration: intravenous
DexamethasoneDrug
Pharmaceutical form:tablet Route of administration: oral
DexamethasoneDrug
Pharmaceutical form:solution Route of administration: intravenous
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel, Cisplatin | Experimental | Induction:One-hour intravenous infusion of docetaxel at 75 mg/m2 followed by a 30 minute intravenous infusion of cisplatin at 75 mg/m2. All patients to be pre-medicated with oral dexamethasone at 8 mg twice daily for 3 days, commencing one day before docetaxel infusion. All patients will be premedicated with intravenous dexamethasone 20 mg to be administered before cisplatin infusion. Docetaxel and cisplatin treatments to be repeated every 21 days for three cycles.
Chemoradiotherapy (CRT): Cisplatin to be administered by 30 minutes intravenous infusion at a dose of 30 mg/m2 weekly starting concomitantly with conventional radiotherapy for a period of 6 weeks. Intravenous cisplatin to be continued for four weeks.
Radiotherapy: Gross disease dose will be 60 Gy/30 fractions and sub clinical dose 45-50 Gy/30 fractions. Receives: Drug: Cisplatin; Drug: DOCETAXEL XRP6976; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who achieve complete response and partial response according to the Response Evaluation Criteria in Solid Tumors (RECIST)
Measured: Day 21 after cycle 3
Secondary outcomes (3)
Proportion of patients who achieve complete response and partial response according to the Response Evaluation Criteria in Solid Tumors (RECIST)
Measured: 8 weeks after end of chemoradiotherapy
Number of patients with Adverse Events (National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 grade)
Measured: From Day 1 cycle 1 up to Day 1 chemoradiotherapy or 30 days after the last cycle of induction therapy, whichever comes first
Number of patients with Adverse Events (National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 grade)
Measured: From Day 1 chemoradiotherapy up to or 30 days after the last day of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study startMay 2014
- Primary completionJul 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of Head and NeckStudies 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02061631
- Sponsor's protocol ID
- DOCETL06445
- Other IDs
- U1111-1131-0614
- Acronym
- DECIDE
- Status last verified
- Oct 2015
- First submitted
- 11 Feb 2014
- Last updated
- 8 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Non Controlled, Non Randomized, Interventional Study to Evaluate the Response Rate After Induction Therapy With DocEtaxel and CIsplatin in Unresectable Locally Advanced Squamous Cell Carcinoma of heaD and nEck
- ClinicalTrials.gov ID
- NCT02061631
- Acronym / sponsor ID
- DECIDE / DOCETL06445
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 13 Feb 2014 (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 evaluate the overall response rate (including complete response and partial response) of subjects treated with combination therapy docetaxel and cisplatin followed by the chemoradiotherapy in patients with locally advanced head and neck cancer
Secondary Objective:
To assess the safety and tolerability of combination therapy docetaxel and cisplatin followed by the chemoradiotherapy in patients with locally advanced head and neck cancer
Detailed description
The treatment duration for each patient will be around six months. Patients included in the study will be treated with induction regimen followed by chemo radiotherapy. Within the induction period there are three cycles (Docetaxel + Cisplatin) every 21 days, with follow-up post-induction at day 21 after cycle three. This is followed by chemoradiotherapy consisting of radiotherapy for six weeks and cisplatin every week for four weeks. The post-consolidation follow up is at eight weeks after end of chemoradiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Docetaxel, Cisplatin | Experimental | Drug: Cisplatin, Drug: DOCETAXEL XRP6976, Drug: DexamethasoneInduction:One-hour intravenous infusion of docetaxel at 75 mg/m2 followed by a 30 minute intravenous infusion of cisplatin at 75 mg/m2. All patients to be pre-medicated with oral dexamethasone at 8 mg twice daily for 3 days, commencing one day before docetaxel infusion. All patients will be premedicated with intravenous dexamethasone 20 mg to be administered before cisplatin infusion. Docetaxel and cisplatin treatments to be repeated every 21 days for three cycles. Chemoradiotherapy (CRT): Cisplatin to be administered by 30 minutes intravenous infusion at a dose of 30 mg/m2 weekly starting concomitantly with conventional radiotherapy for a period of 6 weeks. Intravenous cisplatin to be continued for four weeks. Radiotherapy: Gross disease dose will be 60 Gy/30 fractions and sub clinical dose 45-50 Gy/30 fractions. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Histologically confirmed, unresectable locally advanced squamous cell carcinoma of head and neck of oral cavity in stage III-IV without evidence of distant metastases.
- No prior chemotherapy or radiation therapy.
- Having at least one measurable lesion in one dimension.
- Age ≥18 and <65 years with Eastern Cooperative Oncology Group ≤ 1.
- Adequate organ function:
Key exclusion criteria (10 listed)
- Peripheral neuropathy > grade 1 or other serious diseases (unstable ischaemic heart disease, acute myocardial infarction six months prior to inclusion, history of significant neurological or psychiatric disorder or active peptic ulcer).
- Being treated concomitantly with corticosteroids (except as pre-medication).
- Patients having another type of cancer.
- Previous chemotherapy or radiotherapy.
- Any previous definitive surgery for squamous cell carcinoma of head and neck.
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 |
|---|---|---|
| CisplatinPharmaceutical form:solution Route of administration: intravenous | Drug | Docetaxel, Cisplatin |
| DOCETAXEL XRP6976Pharmaceutical form:solution Route of administration: intravenous | Drug | Docetaxel, Cisplatin |
| DexamethasonePharmaceutical form:tablet Route of administration: oral | Drug | Docetaxel, Cisplatin |
| DexamethasonePharmaceutical form:solution Route of administration: intravenous | Drug | Docetaxel, Cisplatin |
Primary outcome
Proportion of patients who achieve complete response and partial response according to the Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Day 21 after cycle 3
3 secondary outcomes
Proportion of patients who achieve complete response and partial response according to the Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: 8 weeks after end of chemoradiotherapy
Number of patients with Adverse Events (National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 grade)
Time frame: From Day 1 cycle 1 up to Day 1 chemoradiotherapy or 30 days after the last cycle of induction therapy, whichever comes first
Number of patients with Adverse Events (National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 grade)
Time frame: From Day 1 chemoradiotherapy up to or 30 days after the last day 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 8 Oct 2015.
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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.
Clinical Sciences & Operations 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 Cisplatin, DOCETAXEL XRP6976 and Dexamethasone in people with Squamous Cell Carcinoma of Head and Neck, run by Sanofi at 1 site in Pakistan.
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 8 inclusion and 10 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 8 Oct 2015. 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 Pakistan. 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?
Proportion of patients who achieve complete response and partial response according to the Response Evaluation Criteria in Solid Tumors (RECIST) (time frame: Day 21 after cycle 3). 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 8 Oct 2015.