Head and Neck CarcinomaPhase 3GORTEC 2009-01NCT01228565
Trial of OTD70DERM® in Radio-dermatitis Induced by Radiotherapy-Erbitux®
A Phase 3 study testing Radiotherapy+Erbitux+OTD70DERM in people with Head and Neck Carcinoma, run by Groupe Oncologie Radiotherapie Tete et Cou at 5 sites in France.
Trial summary
The aim of this randomized trial is to compare the rate of radio-dermatitis grade 2+ (NCI-CTC V3.0) in patients receiving radiotherapy+Erbitux+placebo versus in patients receiving radiotherapy+Erbitux+OTD70DERM® for the treatment of head and neck carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Carcinoma
- What is being tested?
- Radiotherapy+Erbitux+OTD70DERM
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 5 sitesFrance
- Study dates
- Aug 2010to May 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Head and neck carcinoma treated by radiotherapy (70Gy) plus Erbitux
Who cannot join
- IMRT; Concomitant chemotherapy
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHI Creteil
Créteil, 94010
Centre de Forcilles
Ferolles Attily, 77150
CLCC Nantes
Nantes, 44085
CHU Pitie Salpetriere
Paris, 75013
Institut Gustave Roussy
Villejuif, 94805
About this study
Official title: Placebo Controlled Randomized Trial of OTD70DERM® in Radio-dermatitis Induced by Radiotherapy-Erbitux®
The aim of this randomized trial is to compare the rate of radio-dermatitis grade 2+ (NCI-CTC V3.0) in patients receiving radiotherapy+Erbitux+placebo versus in patients receiving radiotherapy+Erbitux+OTD70DERM® for the treatment of head and neck carcinoma.
- Conditions
- Head and Neck Carcinoma
- Being tested
- Radiotherapy + Erbitux® + placebo, Radiotherapy+Erbitux+OTD70DERM
- Keywords
- Head and neck carcinoma treated by radiotherapy plus erbitux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiotherapy + Erbitux® + placeboOther
3D radiotherapy 70 Gy / 7 weeks (no IRMT); Erbitux once a week, 1 week before radiotherapy and during radiotherapy ; Placebo local application, once a day, every day during the radiotherapy
Radiotherapy+Erbitux+OTD70DERMOther
3D radiotherapy 70 Gy / 7 weeks (no IRMT); Erbitux once a week, 1 week before radiotherapy and during radiotherapy ; OTD70DERM local application, once a day, every day during the radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Radiotherapy+Erbitux+Placebo Receives: Other: Radiotherapy + Erbitux® + placebo |
| OTD70DERM | Experimental | Radiotherapy+Erbitux+OTD70DERM® Receives: Other: Radiotherapy+Erbitux+OTD70DERM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radio-dermatitis grade 2, 3, 4 (NCI-CTC V3)
Radio-dermatitis grade 2, 3, 4 (according to the NCI-CTC V3. Radio-dermatitis will be evaluated twice a week during radiotherapy and at M1, M2 and M3 after end of treatment.
Measured: 3 months
Secondary outcomes (1)
Quality of life
Quality of life by the Dermatology Life Quality Index (DLQI)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2010 (estimated)
- Study startAug 2010
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Oncologie Radiotherapie Tete et Cou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01228565
- Sponsor's protocol ID
- GORTEC 2009-01
- Acronym
- GORTEC 2009-01
- Status last verified
- Mar 2015
- First submitted
- 25 Oct 2010
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo Controlled Randomized Trial of OTD70DERM® in Radio-dermatitis Induced by Radiotherapy-Erbitux®
- ClinicalTrials.gov ID
- NCT01228565
- Acronym / sponsor ID
- GORTEC 2009-01 / GORTEC 2009-01
- Conditions
- Head and Neck Carcinoma
- Keywords
- Head and neck carcinoma treated by radiotherapy plus erbitux
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Groupe Oncologie Radiotherapie Tete et CouUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 26 Oct 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 aim of this randomized trial is to compare the rate of radio-dermatitis grade 2+ (NCI-CTC V3.0) in patients receiving radiotherapy+Erbitux+placebo versus in patients receiving radiotherapy+Erbitux+OTD70DERM® for the treatment of head and neck carcinoma.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Radiotherapy + Erbitux® + placeboRadiotherapy+Erbitux+Placebo |
| OTD70DERM | Experimental | Other: Radiotherapy+Erbitux+OTD70DERMRadiotherapy+Erbitux+OTD70DERM® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Head and neck carcinoma treated by radiotherapy (70Gy) plus Erbitux
Key exclusion criteria (1 listed)
- IMRT; Concomitant chemotherapy
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 |
|---|---|---|
| Radiotherapy + Erbitux® + placebo3D radiotherapy 70 Gy / 7 weeks (no IRMT); Erbitux once a week, 1 week before radiotherapy and during radiotherapy ; Placebo local application, once a day, every day during the radiotherapy | Other | Placebo |
| Radiotherapy+Erbitux+OTD70DERM3D radiotherapy 70 Gy / 7 weeks (no IRMT); Erbitux once a week, 1 week before radiotherapy and during radiotherapy ; OTD70DERM local application, once a day, every day during the radiotherapy | Other | OTD70DERM |
Primary outcome
Radio-dermatitis grade 2, 3, 4 (NCI-CTC V3)
Time frame: 3 months
Radio-dermatitis grade 2, 3, 4 (according to the NCI-CTC V3. Radio-dermatitis will be evaluated twice a week during radiotherapy and at M1, M2 and M3 after end of treatment.
1 secondary outcome
Quality of life
Time frame: 3 months
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 24 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Radiotherapy+Erbitux+OTD70DERM in people with Head and Neck Carcinoma, 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 1 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 24 Mar 2015. 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. Some participants in this study may receive a placebo. 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?
Radio-dermatitis grade 2, 3, 4 (NCI-CTC V3) (time frame: 3 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 24 Mar 2015.