Squamous Cell Carcinoma of the OropharynxNCT02552550
Swallowing, Speech and Quality of Life of Patients With Carcinoma of the Oropharynx
An observational study of Squamous Cell Carcinoma of the Oropharynx, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
The curative treatment and organ preservation in advanced squamous cell carcinoma of the oropharynx is multimodal. It involves induction chemotherapy and depending on the response radio-chemotherapy or surgery. The combination of these methods has important functional consequences. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Squamous Cell Carcinoma of the Oropharynx
- What is being tested?
- Ability to swallow, speak and quality of life
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jul 2013to 20 Sep 2016
- Phase
- Observational
- 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
Study population: Patietn with T3 or T4 stage squamous cell cancer of the oropharynx
Who may be able to join
- Patient with stage T3 or T4 squamous cell carcinoma of the oropharynx previously untreated.
- Performance status 0 or 1
- Tumor histology proving squamous cell carcinoma
Who cannot join
- Visceral metastases at initial assessment
- Contraindication to surgery and / or chemotherapy such as:
- A history of other cancer (except basal cell carcinoma skin or cervical cancer in situ)
- 2nd associated cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Swallowing, Speech and Quality of Life of Patients With Stage T3-T4 Squamous Cell Carcinoma of the Oropharynx Before and After Multimodal Treatment With Curative Intent
The curative treatment and organ preservation in advanced squamous cell carcinoma of the oropharynx is multimodal. It involves induction chemotherapy and depending on the response radio-chemotherapy or surgery. The combination of these methods has important functional consequences.
The aim of this prospective pilot study is to describe swallowing, speech, but also patients' quality of life before and after therapeutic management (existing studies measuring these functions after treatment but not before).
Read the detailed description
This study will not change the patient's treatment. This will just be an evaluation, before any treatment, his ability to swallow, speak then, as in normal practice, after 3, 6 and 12 months after treatment.
- Being tested
- Ability to swallow, speak and quality of life
- Keywords
- squamous cell carcinoma of the oropharynx, swallowing, speech, quality of life
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ability to swallow, speak and quality of lifeProcedure or surgery
This study will not change the patient's treatment. This will just be an evaluation, before any treatment, his ability to swallow, speak, then his quality of life, as in normal practice, after 3, 6 and 12 months after treatment.
| Study group | Role | What they receive |
|---|---|---|
| Ability to swallow, speak and quality of life | This will just be an evaluation, before any treatment, his ability to swallow, speak and quality of life then, as in normal practice, after 3, 6 and 12 months after treatment. Receives: Procedure: Ability to swallow, speak and quality of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from swallowing disorder
A swallowing disorder will be determined by conducting a video-endoscopy and voluntary swallowing reflex (composite measure)
Measured: between day 0 and 1 year
Secondary outcomes (2)
Change from phonation disorder
Phonation disorders will be evaluated by the scale "Voice Handicap Index" (composite measure)
Measured: between day 0 and 1 year
Change from quality of life
The quality of life will be assessed by the Quality of Life scale EORTC QLQ-C30 and QLC-HN35 (composite measure)
Measured: between day 0 and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study start25 Jul 2013
- Primary completion20 Sep 2016
- Study completion20 Sep 2016
Why it stopped: rate of inclusion too low
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 the OropharynxStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Michel PRADES, MD PhD, Principal investigator, CHU de SAINT-ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02552550
- Sponsor's protocol ID
- 1208112
- Other IDs
- 2012-A00904-39
- Status last verified
- Jun 2018
- First submitted
- 11 Sep 2015
- Last updated
- 4 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Swallowing, Speech and Quality of Life of Patients With Stage T3-T4 Squamous Cell Carcinoma of the Oropharynx Before and After Multimodal Treatment With Curative Intent
- ClinicalTrials.gov ID
- NCT02552550
- Acronym / sponsor ID
- 1208112
- Keywords
- squamous cell carcinoma of the oropharynx, swallowing, speech, quality of life
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: rate of inclusion too low
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 25 Jul 2013 (actual)
- Primary completion
- 20 Sep 2016 (actual)
- Study completion
- 20 Sep 2016 (actual)
- First posted
- 17 Sep 2015 (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 curative treatment and organ preservation in advanced squamous cell carcinoma of the oropharynx is multimodal. It involves induction chemotherapy and depending on the response radio-chemotherapy or surgery. The combination of these methods has important functional consequences.
The aim of this prospective pilot study is to describe swallowing, speech, but also patients' quality of life before and after therapeutic management (existing studies measuring these functions after treatment but not before).
Detailed description
This study will not change the patient's treatment. This will just be an evaluation, before any treatment, his ability to swallow, speak then, as in normal practice, after 3, 6 and 12 months after treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ability to swallow, speak and quality of life | – | Procedure: Ability to swallow, speak and quality of lifeThis will just be an evaluation, before any treatment, his ability to swallow, speak and quality of life then, as in normal practice, after 3, 6 and 12 months after treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patietn with T3 or T4 stage squamous cell cancer of the oropharynx
Key inclusion criteria (3 listed)
- Patient with stage T3 or T4 squamous cell carcinoma of the oropharynx previously untreated.
- Performance status 0 or 1
- Tumor histology proving squamous cell carcinoma
Key exclusion criteria (4 listed)
- Visceral metastases at initial assessment
- Contraindication to surgery and / or chemotherapy such as:
- A history of other cancer (except basal cell carcinoma skin or cervical cancer in situ)
- 2nd associated cancer
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 |
|---|---|---|
| Ability to swallow, speak and quality of lifeThis study will not change the patient's treatment. This will just be an evaluation, before any treatment, his ability to swallow, speak, then his quality of life, as in normal practice, after 3, 6 and 12 months after treatment. | Procedure or surgery | Ability to swallow, speak and quality of life |
Primary outcome
change from swallowing disorder
Time frame: between day 0 and 1 year
A swallowing disorder will be determined by conducting a video-endoscopy and voluntary swallowing reflex (composite measure)
2 secondary outcomes
Change from phonation disorder
Time frame: between day 0 and 1 year
Change from quality of life
Time frame: between day 0 and 1 year
Results and safety
The study was stopped early (reason given: rate of inclusion too low). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2018.
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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.
Jean-Michel PRADES, MD PhD principal investigator
CHU de SAINT-ETIENNE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Squamous Cell Carcinoma of the Oropharynx, run by Centre Hospitalier Universitaire de Saint Etienne 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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 4 Jun 2018. 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.
Are results available for this study?
The study was stopped early (reason given: rate of inclusion too low). Results are not available in the source record.
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?
change from swallowing disorder (time frame: between day 0 and 1 year). 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 4 Jun 2018.