Squamous Cell Head and Neck CarcinomaPhase 32007/02NCT01233843
Chemoradiotherapy HNSCC, Randomized Study, Docetaxel,Cisplatin, 5FU,Erbitux.
A Phase 3 study testing carboplatin, 5 fluorouracil and radiation therapy in people with Squamous Cell Head and Neck Carcinoma, run by Groupe Oncologie Radiotherapie Tete et Cou at 1 site in France.
Trial summary
The purpose of this study is to demonstrate that induction chemotherapy followed by radiation therapy plus Cetuximab will give better results than the validated treatment (chemoradiotherapy), for treatment of locoregional advanced head and neck cancers. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Squamous Cell Head and Neck Carcinoma
- What is being tested?
- carboplatin, 5 fluorouracil and radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 1 siteFrance
- Study dates
- 18 May 2009to 6 Nov 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
- head and neck locally advanced,non metastatic carcinoma
- not suitable for surgery
Who cannot join
- non squamous cell head and neck cancer
- previous malignancy
- previous treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III Randomized Multicenter Study,Comparing an Induction Chemotherapy Followed by Irradiation and Concurrent Erbitux Versus Chemoradiotherapy for Patients With Locoregional Advanced Head and Neck Cancers
The purpose of this study is to demonstrate that induction chemotherapy followed by radiation therapy plus Cetuximab will give better results than the validated treatment (chemoradiotherapy), for treatment of locoregional advanced head and neck cancers.
Read the detailed description
Concurrent chemoradiotherapy (radiotherapy+ carboplatin + 5FU) is a validated treatment for patients with locoregional advanced head and neck cancers.
This study evaluates the outcome of induction chemotherapy (docetaxel, cisplatin, 5 FU) followed by radiation therapy + Erbitux for patients with head and neck carcinoma with almost one measurable lesion by RMI or CT scan.
We hope we can improve the progression free survival of 14% at two years .
- Conditions
- Squamous Cell Head and Neck Carcinoma
- Being tested
- carboplatin, 5 fluorouracil, radiation therapy
- Keywords
- induction chemotherapy, followed by irradiation and concurrent Erbitux, or radiochemotherapy
- 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.
carboplatinDrug
70 mg per m2 and per day for four days. day 1; day 22; day 43
5 fluorouracilDrug
600mg per m2 per day for four days. 3 cycles day 1; day 22; day 43
radiation therapyRadiation
total dose: 70 grays. The patient receives 2 grays per day; five days a week during 7 weeks
| Study group | Role | What they receive |
|---|---|---|
| Drug and radiation | Other | Radiotherapy : 70 grays , fractionization : 2Gy/day, 5 days / week, for 7 weeks . Concurrent administration of Carboplatin: 70 mg/m2/day (day 1 until day 4)and 5FU 600 mg/m2/day (day 1 until day 4). Weeks 1; 4; 7. Receives: Drug: carboplatin; Drug: 5 fluorouracil; Radiation: radiation therapy |
| drug and radiation | Experimental | Induction chemotherapy by Docetaxel 100mg/m2, day 1; cisplatin 100mg/m2, day 1; 5-Fluorouracil 1000mg/m2 (from day 1 to day 5), for a total of three cycles .Those cycles are administrated at day 1; day 22, day43.
This induction chemotherapy is followed ( for responders or stable disease patients)by radiotherapy (70 grays for 7 weeks) and concurrent Erbitux( weekly administration). Receives: Drug: carboplatin; Drug: 5 fluorouracil; Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate of the treatment
measure of the tumor
Measured: by CT scan or MRI and endoscopy 2 years after the end of treatment
Secondary outcomes (1)
The second focus of this study is to compare Overall survival between the two arms . It is defined as the time from the date of randomization to the date of death from any cause.
Aftercare every six months
Measured: 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 posted3 Nov 2010 (estimated)
- Study start18 May 2009
- Primary completion6 Nov 2018
- Study completion6 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Head and Neck CarcinomaStudies of the same condition, open and under way.
- 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
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Oncologie Radiotherapie Tete et Cou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lionnel GEOFFROIS, oncologist, Study director, Centre Alexis Vautrin NANCY FranceEtienne BARDET, oncologist, Principal investigator, Centre Rene Gauducheau NANTES FranceChristian SIRE, oncologist, Principal investigator, Hopital de Bretagne Sud LORIENT FranceLaurent MARTIN, oncologist, Principal investigator, Centre Guillaume le Conquerant LE HAVRE FranceJean-Marc TOURANI, oncologist, Principal investigator, CHU POITIERS FrancePhilippe MAINGON, oncologist, Principal investigator, Centre Georges Francois LeclercAyman ZAWADI, oncologist, Principal investigator, CHD de Vendee LA ROCHE SUR YON FranceFrançois GUICHARD, oncologist, Principal investigator, Polyclinique de BORDEAUX NORD France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01233843
- Sponsor's protocol ID
- GORTEC 2007-02
- Acronym
- 2007/02
- Status last verified
- Jan 2019
- First submitted
- 25 Oct 2010
- Last updated
- 18 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Multicenter Study,Comparing an Induction Chemotherapy Followed by Irradiation and Concurrent Erbitux Versus Chemoradiotherapy for Patients With Locoregional Advanced Head and Neck Cancers
- ClinicalTrials.gov ID
- NCT01233843
- Acronym / sponsor ID
- 2007/02 / GORTEC 2007-02
- Conditions
- Squamous Cell Head and Neck Carcinoma
- Keywords
- induction chemotherapy, followed by irradiation and concurrent Erbitux, or radiochemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- Groupe Oncologie Radiotherapie Tete et CouUniversity, hospital or other
- Study start
- 18 May 2009 (actual)
- Primary completion
- 6 Nov 2018 (actual)
- Study completion
- 6 Nov 2018 (actual)
- First posted
- 3 Nov 2010 (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 purpose of this study is to demonstrate that induction chemotherapy followed by radiation therapy plus Cetuximab will give better results than the validated treatment (chemoradiotherapy), for treatment of locoregional advanced head and neck cancers.
Detailed description
Concurrent chemoradiotherapy (radiotherapy+ carboplatin + 5FU) is a validated treatment for patients with locoregional advanced head and neck cancers.
This study evaluates the outcome of induction chemotherapy (docetaxel, cisplatin, 5 FU) followed by radiation therapy + Erbitux for patients with head and neck carcinoma with almost one measurable lesion by RMI or CT scan.
We hope we can improve the progression free survival of 14% at two years .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug and radiation | Other | Drug: carboplatin, Drug: 5 fluorouracil, Radiation: radiation therapyRadiotherapy : 70 grays , fractionization : 2Gy/day, 5 days / week, for 7 weeks . Concurrent administration of Carboplatin: 70 mg/m2/day (day 1 until day 4)and 5FU 600 mg/m2/day (day 1 until day 4). Weeks 1; 4; 7. |
| drug and radiation | Experimental | Drug: carboplatin, Drug: 5 fluorouracil, Radiation: radiation therapyInduction chemotherapy by Docetaxel 100mg/m2, day 1; cisplatin 100mg/m2, day 1; 5-Fluorouracil 1000mg/m2 (from day 1 to day 5), for a total of three cycles .Those cycles are administrated at day 1; day 22, day43. This induction chemotherapy is followed ( for responders or stable disease patients)by radiotherapy (70 grays for 7 weeks) and concurrent Erbitux( weekly administration). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- head and neck locally advanced,non metastatic carcinoma
- not suitable for surgery
Key exclusion criteria (3 listed)
- non squamous cell head and neck cancer
- previous malignancy
- previous treatment
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 |
|---|---|---|
| carboplatin70 mg per m2 and per day for four days. day 1; day 22; day 43 | Drug | Drug and radiation, drug and radiation |
| 5 fluorouracil600mg per m2 per day for four days. 3 cycles day 1; day 22; day 43 | Drug | Drug and radiation, drug and radiation |
| radiation therapytotal dose: 70 grays. The patient receives 2 grays per day; five days a week during 7 weeks | Radiation | Drug and radiation, drug and radiation |
Primary outcome
Complete response rate of the treatment
Time frame: by CT scan or MRI and endoscopy 2 years after the end of treatment
measure of the tumor
1 secondary outcome
The second focus of this study is to compare Overall survival between the two arms . It is defined as the time from the date of randomization to the date of death from any cause.
Time frame: 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 18 Jan 2019.
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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.
Lionnel GEOFFROIS, oncologist study director
Centre Alexis Vautrin NANCY France
Etienne BARDET, oncologist principal investigator
Centre Rene Gauducheau NANTES France
Christian SIRE, oncologist principal investigator
Hopital de Bretagne Sud LORIENT France
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 carboplatin, 5 fluorouracil and radiation therapy in people with Squamous Cell Head and Neck Carcinoma, run by Groupe Oncologie Radiotherapie Tete et Cou at 1 site in France.
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 2 inclusion and 3 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 18 Jan 2019. 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 France. 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?
Complete response rate of the treatment (time frame: by CT scan or MRI and endoscopy 2 years after the end of treatment). 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 18 Jan 2019.