Study Stopped
rate of inclusion too low
Swallowing, Speech and Quality of Life of Patients With Carcinoma of the Oropharynx
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
2 other identifiers
observational
12
1 country
1
Brief 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. 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2013
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 25, 2013
CompletedFirst Submitted
Initial submission to the registry
September 11, 2015
CompletedFirst Posted
Study publicly available on registry
September 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 20, 2016
CompletedJune 4, 2018
June 1, 2018
3.2 years
September 11, 2015
June 1, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change from swallowing disorder
A swallowing disorder will be determined by conducting a video-endoscopy and voluntary swallowing reflex (composite measure)
between day 0 and 1 year
Secondary Outcomes (2)
Change from phonation disorder
between day 0 and 1 year
Change from quality of life
between day 0 and 1 year
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
Patietn with T3 or T4 stage squamous cell cancer of the oropharynx
You may qualify if:
- 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
You may not qualify if:
- 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)
- nd associated cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHu de SAINT-ETIENNE
Saint-Etienne, 42000, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Michel PRADES, MD PhD
CHU de SAINT-ETIENNE
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2015
First Posted
September 17, 2015
Study Start
July 25, 2013
Primary Completion
September 20, 2016
Study Completion
September 20, 2016
Last Updated
June 4, 2018
Record last verified: 2018-06