HNSCCPhase 32007-01NCT00609284
Randomized Trial of Concomitant Chemotherapy in Patients With Locally Advanced HNSCC Treated by Radiotherapy-erbitux
A Phase 3 study testing cetuximab, Carboplatin, 5FU concomitant and Radiotherapy in people with HNSCC, run by Groupe Oncologie Radiotherapie Tete et Cou at 5 sites in France.
Trial summary
The aim of the trial is to study the efficacy of adding concomitant chemotherapy (carboplatin/5FU) to Erbitux-radiotherapy in patients with locally advanced head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HNSCC
- What is being tested?
- cetuximab, Carboplatin, 5FU concomitant and Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 406 participants
- Where
- 5 sitesFrance
- Study dates
- 15 Feb 2008to 26 Mar 2019
- 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
- Squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, larynx
- Stage III - IV (T0-T4, N0-N2b, M0)
- Not resected
- Karnofsky PS>=80
- Informed consent signed
Who cannot join
- Contra indication to chemotherapy or cetuximab
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Centre hospitalier Annecy
Annecy, 74000
Centre Jean Perrin
Clermont-Ferrand, 63000
Centre Guillaume Le Conquerant
Le Havre, 76600
Centre hospitalier de Bretagne Sud
Lorient, 56322
Institut Gustave Roussy
Villejuif, 94805
About this study
The aim of the trial is to study the efficacy of adding concomitant chemotherapy (carboplatin/5FU) to Erbitux-radiotherapy in patients with locally advanced head and neck cancer.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cetuximabDrug
D-7, D1, D8, D15, D22, D29, D43, D50
Carboplatin, 5FU concomitantDrug
Carboplatin 70mg/m²/D ; 5FU 600 mg/m²/D, D1-4, D22-25, D43-46
RadiotherapyRadiation
70 Gy in 7 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Radiotherapy 70Gy, Erbitux, Carboplatin-5FU Receives: Drug: cetuximab; Drug: Carboplatin, 5FU concomitant; Radiation: Radiotherapy |
| 2 | Active comparator | Radiotherapy 70Gy, Erbitux Receives: Drug: cetuximab; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: 3 years
Secondary outcomes (1)
Loco-regional control
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
- Study start15 Feb 2008
- Primary completion26 Mar 2018
- Study completion26 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HNSCCStudies 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
- 406 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Oncologie Radiotherapie Tete et Cou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean BOURHIS, MD, PhD, Study chair, GORTEC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00609284
- Sponsor's protocol ID
- GORTEC 2007-01
- Acronym
- 2007-01
- Status last verified
- Apr 2020
- First submitted
- 25 Jan 2008
- Last updated
- 15 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Concomitant Chemotherapy in Patients With Locally Advanced HNSCC Treated by Radiotherapy-erbitux
- ClinicalTrials.gov ID
- NCT00609284
- Acronym / sponsor ID
- 2007-01 / GORTEC 2007-01
- Conditions
- HNSCC
- Keywords
- Stage III, Stage IV, locally advanced
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 406 participants (actual)
- Lead sponsor
- Groupe Oncologie Radiotherapie Tete et CouUniversity, hospital or other
- Study start
- 15 Feb 2008 (actual)
- Primary completion
- 26 Mar 2018 (actual)
- Study completion
- 26 Mar 2019 (actual)
- First posted
- 7 Feb 2008 (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 aim of the trial is to study the efficacy of adding concomitant chemotherapy (carboplatin/5FU) to Erbitux-radiotherapy in patients with locally advanced head and neck cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: cetuximab, Drug: Carboplatin, 5FU concomitant, Radiation: RadiotherapyRadiotherapy 70Gy, Erbitux, Carboplatin-5FU |
| 2 | Active comparator | Drug: cetuximab, Radiation: RadiotherapyRadiotherapy 70Gy, Erbitux |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, larynx
- Stage III - IV (T0-T4, N0-N2b, M0)
- Not resected
- Karnofsky PS>=80
- Informed consent signed
Key exclusion criteria (1 listed)
- Contra indication to chemotherapy or cetuximab
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 |
|---|---|---|
| cetuximabD-7, D1, D8, D15, D22, D29, D43, D50 | Drug | 1, 2 |
| Carboplatin, 5FU concomitantCarboplatin 70mg/m²/D ; 5FU 600 mg/m²/D, D1-4, D22-25, D43-46 | Drug | 1 |
| Radiotherapy70 Gy in 7 weeks | Radiation | 1, 2 |
Primary outcome
Progression free survival
Time frame: 3 years
1 secondary outcome
Loco-regional control
Time frame: 3 years
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 15 Apr 2020.
Related trials for HNSCC
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
RecruitingPhase 3
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma
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.
Jean BOURHIS, MD, PhD study chair
GORTEC
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cetuximab, Carboplatin, 5FU concomitant and Radiotherapy in people with HNSCC, run by Groupe Oncologie Radiotherapie Tete et Cou at 5 sites 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 5 inclusion and 1 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 15 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Progression free survival (time frame: 3 years). 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 15 Apr 2020.