Head and Neck CancerPhase 2TOQUALNCT01548846
Impact of Tomotherapy on Xerostomia and Quality of Life of Patients With Cancer of the Upper Aero-digestive Tract
A Phase 2 study testing Tomotherapy in people with Head and Neck Cancer and Radiotherapy by Tomotherapy Exclusive, run by Centre Francois Baclesse at 1 site in France.
Trial summary
This is a study whose main objective is to evaluate prospectively the proportion of patients with severe xerostomia one year after treatment with tomotherapy for head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Radiotherapy by Tomotherapy Exclusive, With or Without Concurrent Chemotherapy
- What is being tested?
- Tomotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- May 2012to Dec 2014
- Phase
- Phase 2
- 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
- Patient (e) old (e) over 18 years
- Patients with squamous cell carcinoma of head and neck (oral cavity, oropharynx, lymphadenopathy without gateway) histologically proven.
- Patient targeted for head and neck radiotherapy by Tomotherapy exclusive with or without concurrent chemotherapy (containing platinum)
- Indication of head and neck radiotherapy bilateral
- All of the TNM stage except metastatic
- Patient has signed informed consent for participation in the study
- Mastery of the French language
Who cannot join
- History of head and neck radiotherapy
- Indication of head and neck radiotherapy unilateral
- Personal history of malignant tumors uncontrolled over the past 5 years
- History of oral sicca syndrome
- Surgical removal of one or more salivary glands (parotid, submandibular gland, sublingual gland)
- Concomitant treatment with amifostine
Show all 14Show fewer
- Concomitant treatment with cetuximab
- Primary tumor of the salivary glands
- Head and neck hyperfractionated radiotherapy and / or accelerated
- Head and neck radiotherapy hypofractionated
- Metastatic disease
- Patient deprived of liberty, under guardianship
- Any medical condition or psychological associate that could compromise the patient's ability to participate in the study
- Refusal of the patient.
Trial locations and contacts
1 site in 1 country.
About this study
This is a study whose main objective is to evaluate prospectively the proportion of patients with severe xerostomia one year after treatment with tomotherapy for head and neck cancer.
- Conditions
- Head and Neck Cancer, Radiotherapy by Tomotherapy Exclusive, With or Without Concurrent Chemotherapy
- Being tested
- Tomotherapy
- Keywords
- tomotherapy, xerostomy, head and neck squamous cell carcinoma
- Medical subject headings
- Head and Neck Neoplasms, 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.
TomotherapyRadiation
Patients receive radiotherapy by Tomotherapy for 7 weeks at the ENT
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportion of patients with xerostomia
Estimate the proportion of patients with xerostomia of grade greater than or equal to 2 assessed by the scale of late toxicity RTOG / EORTC 12 months after completion of radiotherapy.
Measured: 12 months after completion of radiotherapy.
Secondary outcomes (6)
Evaluation of acute and late xerostomia
Evaluation of acute xerostomia
Measured: after 3, 6 and 12 months after radiotherapy
Measurement of salivary flow with and without stimulation
Measurement of salivary flow with and without stimulation
Measured: at 3, 6 and 12 months after end of radiotherapy
Evaluation of the incidence of acute side effects of radiotherapy
Evaluation of the incidence of acute and late side effects of radiotherapy
Measured: Weekly during radiotherapy
Evaluation of the incidence of late side effects of radiotherapy
Evaluation of the incidence of late side effects of radiotherapy
Measured: At 3, 6 and 12 months after radiotherapy
Evaluation of quality of life and fatigue
Evaluation of quality of life and fatigue
Measured: At 3, 6 and 12 months after radiotherapy
Evaluation of overall survival and progression-free survival
Evaluation of overall survival and progression-free survival
Measured: at 3, 6 and 12 months after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: lack of recrutment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies 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 2
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- bernard GERY, MD, Principal investigator, Centre François Baclesse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01548846
- Sponsor's protocol ID
- TOQUAL
- Acronym
- TOQUAL
- Status last verified
- Mar 2014
- First submitted
- 6 Mar 2012
- Last updated
- 13 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Tomotherapy on Xerostomia and Quality of Life of Patients With Cancer of the Upper Aero-digestive Tract
- ClinicalTrials.gov ID
- NCT01548846
- Acronym / sponsor ID
- TOQUAL / TOQUAL
- Conditions
- Head and Neck Cancer, Radiotherapy by Tomotherapy Exclusive, With or Without Concurrent Chemotherapy
- Keywords
- tomotherapy, xerostomy, head and neck squamous cell carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of recrutment
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 8 Mar 2012 (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.
This is a study whose main objective is to evaluate prospectively the proportion of patients with severe xerostomia one year after treatment with tomotherapy for head and neck cancer.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient (e) old (e) over 18 years
- Patients with squamous cell carcinoma of head and neck (oral cavity, oropharynx, lymphadenopathy without gateway) histologically proven.
- Patient targeted for head and neck radiotherapy by Tomotherapy exclusive with or without concurrent chemotherapy (containing platinum)
- Indication of head and neck radiotherapy bilateral
- All of the TNM stage except metastatic
Key exclusion criteria (14 listed)
- History of head and neck radiotherapy
- Indication of head and neck radiotherapy unilateral
- Personal history of malignant tumors uncontrolled over the past 5 years
- History of oral sicca syndrome
- Surgical removal of one or more salivary glands (parotid, submandibular gland, sublingual gland)
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 |
|---|---|---|
| TomotherapyPatients receive radiotherapy by Tomotherapy for 7 weeks at the ENT | Radiation | – |
Primary outcome
the proportion of patients with xerostomia
Time frame: 12 months after completion of radiotherapy.
Estimate the proportion of patients with xerostomia of grade greater than or equal to 2 assessed by the scale of late toxicity RTOG / EORTC 12 months after completion of radiotherapy.
6 secondary outcomes
Evaluation of acute and late xerostomia
Time frame: after 3, 6 and 12 months after radiotherapy
Measurement of salivary flow with and without stimulation
Time frame: at 3, 6 and 12 months after end of radiotherapy
Evaluation of the incidence of acute side effects of radiotherapy
Time frame: Weekly during radiotherapy
Evaluation of the incidence of late side effects of radiotherapy
Time frame: At 3, 6 and 12 months after radiotherapy
Evaluation of quality of life and fatigue
Time frame: At 3, 6 and 12 months after radiotherapy
Evaluation of overall survival and progression-free survival
Time frame: at 3, 6 and 12 months after radiotherapy
Results and safety
The study was stopped early (reason given: lack of recrutment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 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.
bernard GERY, MD principal investigator
Centre François Baclesse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tomotherapy in people with Head and Neck Cancer and Radiotherapy by Tomotherapy Exclusive, run by Centre Francois Baclesse 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 7 inclusion and 14 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 13 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: lack of recrutment). 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?
the proportion of patients with xerostomia (time frame: 12 months after completion of radiotherapy.). 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 13 Mar 2015.