Primary Non-operated Squamous Cell Carcinoma of Oral CavityPhase 2NCT01287390
Adaptive, Image-guided, Intensity-modulated Radiotherapy for Head and Neck Cancer in the Reduced Volumes of Elective Neck
A Phase 2 study testing video fluoroscopy, extra imaging and scoring acute toxicity in people with Primary Non-operated Squamous Cell Carcinoma of Oral Cavity and Primary Non-operated Squamous Cell Carcinoma of Oropharynx, run by University Hospital, Ghent at 2 sites in Belgium.
Trial summary
Severe acute and late dysphagia is now considered as a dose-limiting toxicity of radio(chemo)therapy for head and neck cancer that significantly affects patients' quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Non-operated Squamous Cell Carcinoma of Oral Cavity, Primary Non-operated Squamous Cell Carcinoma of Oropharynx, Primary Non-operated Squamous Cell Carcinoma of Hypopharynx
- What is being tested?
- video fluoroscopy, extra imaging and scoring acute toxicity
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesBelgium
- Study dates
- Oct 2011to May 2015
- 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
- Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx and larynx.
- Primary non-resected tumor and/or patients refused surgery
- Stage T1-4, N0-3; for cancer of the glottis T3-4 or T any N1-3
- Decision of curative radiotherapy or radiochemotherapy made by a Multidisciplinary Group of Head and Neck Tumors at UZ Gent and UZ Gasthuisberg Leuven
- Karnofsky performance status >= 70 %
- Age >= 18 years old
- Informed consent obtained, signed and dated before specific protocol procedures
Who cannot join
- Treatment combined with brachytherapy
- Prior irradiation to the head and neck region
- Surgery of the primary tumor except lymph node dissection prior to radiotherapy
- induction chemotherapy
- history of prior malignancies, except for cured non-melanoma skin cancer, curatively treated in-situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease at least 5 years
- Distant metastases
Show all 11Show fewer
- Creatinine clearance (Cockroft-Gault) =< 60 milliliter/minute before treatment or creatinine value > 1,3 milligram/deciliter
- Known allergy to the CT-contrast agents
- Pregnant or lactating women
- Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
- Patient unlikely to comply with protocol, i.e. uncooperative attitude, inability to return for follow-up visits and unlikely to complete the study
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
University Hospital Ghent
Ghent, 9000
University Hospital Leuven
Leuven, 3000
About this study
Official title: Adaptive, Image-guided, Intensity-modulated Radiotherapy for Head and Neck Cancer in the Reduced Volumes of Elective Neck: a Multicenter, Two-arm, Randomized Phase II Trial.
Severe acute and late dysphagia is now considered as a dose-limiting toxicity of radio(chemo)therapy for head and neck cancer that significantly affects patients' quality of life. We propose to preserve swallowing function by:
- adapting (individualizing) treatment (intensity-modulated radiotherapy: IMRT) to per-treatment changes occurring in the tumor and surrounding organs and tissues;
- reducing the volumes of elective neck, that may result in significant decrease of severe acute and late dysphagia.
- Conditions
- Primary Non-operated Squamous Cell Carcinoma of Oral Cavity, Primary Non-operated Squamous Cell Carcinoma of Oropharynx, Primary Non-operated Squamous Cell Carcinoma of Hypopharynx, Primary Non-operated Squamous Cell Carcinoma of Larynx
- Being tested
- video fluoroscopy, extra imaging, scoring acute toxicity, scoring of late toxicity, scoring quality of life (QOL)
- Keywords
- squamous cell carcinoma, oral cavity, oropharynx, hypopharynx, larynx
- Medical subject headings
- Carcinoma, Squamous Cell, Laryngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video fluoroscopyProcedure or surgery
video fluoroscopy of swallowing function at baseline, 6 months and 12 months follow-up
extra imagingProcedure or surgery
For tumor response, 2 extra CT or Fludeoxyglucose (18F)-Positron Emission Tomography (PET)/Computed Tomography (CT), and/or Magnetic Resonance Imaging (MRI) will be performed.
scoring acute toxicityOther
Acute toxicity scoring, based on Common Toxicity criteria (CTC) version 2.
scoring of late toxicityOther
Scoring of late toxicity with the 'late effects in normal tissues subjective, objective, management and analytic'(LENT-SOMA) scale.
scoring quality of life (QOL)Other
Quality of life is scored with the Quality of Life Questionnaire of the 'European Organisation for Research and Treatment of Cancer' (EORTC QOL-C30) and the Head and Neck Cancer Specific Quality of Life Questionnaire (QLQ-H\&N 35).
| Study group | Role | What they receive |
|---|---|---|
| standard radiotherapy treatment | Active comparator | These patients receive the normal standard treatment. Receives: Procedure: video fluoroscopy; Other: scoring acute toxicity; Other: scoring of late toxicity; Other: scoring quality of life (QOL) |
| adaptive radiotherapy | Experimental | These patients receive the adaptive image-guided intensity-modulated radiotherapy (IMRT) for head and neck cancer. Receives: Procedure: video fluoroscopy; Procedure: extra imaging; Other: scoring acute toxicity; Other: scoring of late toxicity; Other: scoring quality of life (QOL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of acute and late treatment-induced dysphagia
Reduction of the rates of acute and late treatment-induced dysphagia with experimental treatment as compared to standard treatment.
Measured: after 1 year
Secondary outcomes (7)
acute treatment-induced toxicity
Measured: weekly during treatment
late treatment-induced toxicity
Measured: after 1, 3, 6, 9 and 12 months
tumor response: imaging
Measured: after 3 months
tumor response: clinical examination
Measured: after 1, 3, 6, 9 and 12 months
local, regional and distant control: imaging
Measured: after 3 months
local, regional and distant control: clinical examination
Measured: after 1,3, 6, 9 and 12 months
local, regional and distant control: biopsy
Measured: from 3 months on
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2011 (estimated)
- Study startOct 2011
- Primary completionMay 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Non-operated Squamous Cell Carcinoma of Oral CavityStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wilfried De Neve, PhD, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01287390
- Sponsor's protocol ID
- 2011/012
- Status last verified
- Jan 2016
- First submitted
- 26 Jan 2011
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive, Image-guided, Intensity-modulated Radiotherapy for Head and Neck Cancer in the Reduced Volumes of Elective Neck: a Multicenter, Two-arm, Randomized Phase II Trial.
- ClinicalTrials.gov ID
- NCT01287390
- Acronym / sponsor ID
- 2011/012
- Conditions
- Primary Non-operated Squamous Cell Carcinoma of Oral Cavity, Primary Non-operated Squamous Cell Carcinoma of Oropharynx, Primary Non-operated Squamous Cell Carcinoma of Hypopharynx, Primary Non-operated Squamous Cell Carcinoma of Larynx
- Keywords
- squamous cell carcinoma, oral cavity, oropharynx, hypopharynx, larynx
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- May 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 1 Feb 2011 (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.
Severe acute and late dysphagia is now considered as a dose-limiting toxicity of radio(chemo)therapy for head and neck cancer that significantly affects patients' quality of life. We propose to preserve swallowing function by:
- adapting (individualizing) treatment (intensity-modulated radiotherapy: IMRT) to per-treatment changes occurring in the tumor and surrounding organs and tissues;
- reducing the volumes of elective neck, that may result in significant decrease of severe acute and late dysphagia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard radiotherapy treatment | Active comparator | Procedure: video fluoroscopy, Other: scoring acute toxicity, Other: scoring of late toxicity, Other: scoring quality of life (QOL)These patients receive the normal standard treatment. |
| adaptive radiotherapy | Experimental | Procedure: video fluoroscopy, Procedure: extra imaging, Other: scoring acute toxicity, Other: scoring of late toxicity, Other: scoring quality of life (QOL)These patients receive the adaptive image-guided intensity-modulated radiotherapy (IMRT) for head and neck cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx and larynx.
- Primary non-resected tumor and/or patients refused surgery
- Stage T1-4, N0-3; for cancer of the glottis T3-4 or T any N1-3
- Decision of curative radiotherapy or radiochemotherapy made by a Multidisciplinary Group of Head and Neck Tumors at UZ Gent and UZ Gasthuisberg Leuven
- Karnofsky performance status >= 70 %
Key exclusion criteria (11 listed)
- Treatment combined with brachytherapy
- Prior irradiation to the head and neck region
- Surgery of the primary tumor except lymph node dissection prior to radiotherapy
- induction chemotherapy
- history of prior malignancies, except for cured non-melanoma skin cancer, curatively treated in-situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease at least 5 years
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 |
|---|---|---|
| video fluoroscopyvideo fluoroscopy of swallowing function at baseline, 6 months and 12 months follow-up | Procedure or surgery | adaptive radiotherapy, standard radiotherapy treatment |
| extra imagingFor tumor response, 2 extra CT or Fludeoxyglucose (18F)-Positron Emission Tomography (PET)/Computed Tomography (CT), and/or Magnetic Resonance Imaging (MRI) will be performed. | Procedure or surgery | adaptive radiotherapy |
| scoring acute toxicityAcute toxicity scoring, based on Common Toxicity criteria (CTC) version 2. | Other | adaptive radiotherapy, standard radiotherapy treatment |
| scoring of late toxicityScoring of late toxicity with the 'late effects in normal tissues subjective, objective, management and analytic'(LENT-SOMA) scale. | Other | adaptive radiotherapy, standard radiotherapy treatment |
| scoring quality of life (QOL)Quality of life is scored with the Quality of Life Questionnaire of the 'European Organisation for Research and Treatment of Cancer' (EORTC QOL-C30) and the Head and Neck Cancer Specific Quality of Life Questionnaire (QLQ-H\&N 35). | Other | adaptive radiotherapy, standard radiotherapy treatment |
Primary outcome
Reduction of acute and late treatment-induced dysphagia
Time frame: after 1 year
Reduction of the rates of acute and late treatment-induced dysphagia with experimental treatment as compared to standard treatment.
7 secondary outcomes
acute treatment-induced toxicity
Time frame: weekly during treatment
late treatment-induced toxicity
Time frame: after 1, 3, 6, 9 and 12 months
tumor response: imaging
Time frame: after 3 months
tumor response: clinical examination
Time frame: after 1, 3, 6, 9 and 12 months
local, regional and distant control: imaging
Time frame: after 3 months
local, regional and distant control: clinical examination
Time frame: after 1,3, 6, 9 and 12 months
local, regional and distant control: biopsy
Time frame: from 3 months on
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 27 Jan 2016.
- Related InfoLink provided by the sponsor.
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.
Wilfried De Neve, PhD, MD principal investigator
University Hospital, Ghent
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing video fluoroscopy, extra imaging and scoring acute toxicity in people with Primary Non-operated Squamous Cell Carcinoma of Oral Cavity and Primary Non-operated Squamous Cell Carcinoma of Oropharynx, run by University Hospital, Ghent at 2 sites in Belgium.
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 11 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 27 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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 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?
Reduction of acute and late treatment-induced dysphagia (time frame: after 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 27 Jan 2016.