Head and Neck CancerNCT02336711
Molecular Imaging-based Dose Escalation in HPV Negative Patients With Locally Advanced SCC of the Oropharynx
A study testing dose escalation in people with Head and Neck Cancer, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 2 sites in Belgium.
Trial summary
Phase I study to assess the feasibility (i.e. early toxicity) of Molecular Imaging-based Dose Escalation in HPV Negative Patients With Locally Advanced SCC of the Oropharynx. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- dose escalation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesBelgium
- Study dates
- Nov 2014to Sep 2016
- Phase
- Interventional
- 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
- Patients older than 18 years
- Patients with squamous cell carcinoma of the oropharynx, HPV-negative (p16 assay)
- T size of 3 cm or more in greatest dimension with the exclusion of tumor with bone infiltration
- N0, N1, N2a, N2b node (AJCC/UICC 7th edition)
- No distant metastasis
- No contra-indication to concomitant chemotherapy
- World Health Organization (WHO) Performance Status of 0 or 1 or Karnofsky performance status ≥ 80.
- Provision of written informed consent
Who cannot join
- Patients with induction chemotherapy will not be eligible
- Previous or concurrent history of cancer, except basal cell skin carcinoma
- Second primary tumor at the time of diagnosis
- Previous treatment with surgery, radiotherapy or chemotherapy for head and neck malignancy
- Any evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, cardiac, hepatic or renal disease), or psychological disorder
- Pregnant or lactating women
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites, 2 recruiting
- Recruiting
Cliniques Universitaires Saint Luc
Brussels, 1200
Vincent Grégoire, MD, PhD
- Not yet recruiting
U.Z. Leuven - Campus Gasthuisberg
Leuven, 3000
Sandra Nuyts, MD, PhD
About this study
Official title: Molecular Imaging-based Dose Escalation in HPV Negative Patients With Locally Advanced Squamous Cell Carcinoma of the Oropharynx: a Phase-I Study.
Phase I study to assess the feasibility (i.e. early toxicity) of Molecular Imaging-based Dose Escalation in HPV Negative Patients With Locally Advanced SCC of the Oropharynx.
Read the detailed description
The objective is to assess the feasibility (i.e. early toxicity) of an adaptive dose escalation through 18F-FDG-PET-based dose painting by numbers in 10 HPV negative patients with locally advanced squamous cell carcinoma of the oropharynx. Treatment will be delivered with Helical Tomotherapy® or volumetric-modulated arc therapy (VMAT). Dose adaptation will be performed at 2 time-points with per-treatment 18F-FDG-PET/CT scans.
- Conditions
- Head and Neck Cancer
- Being tested
- dose escalation
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dose escalationRadiation
molecular imaging based radiotherapy dose escalation
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation | Experimental | Dose escalation Receives: Radiation: dose escalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute toxicity
Measured: up to 3 months following the completion of radiotherapy
Secondary outcomes (4)
Primary tumor control probability
Measured: at 1 and 2 years
Late toxicity
Measured: at 1 and 2 years
Progression-free survival
Measured: at 1 and 2 years
Overall survival
Measured: at 1 and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study startNov 2014
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
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.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Grégoire, MD, PhD, Principal investigator, Department of Radiation Oncology, and Center for Molecular Imaging, Radiotherapy and Oncology (MIRO), Institut de Recherche Expérimentale et Clinique (IREC), Université catholique de Louvain, St-Luc University Hospital, Brussels, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02336711
- Sponsor's protocol ID
- 2013/13MAR/117
- Status last verified
- Jun 2016
- First submitted
- 8 Jan 2015
- Last updated
- 3 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Imaging-based Dose Escalation in HPV Negative Patients With Locally Advanced Squamous Cell Carcinoma of the Oropharynx: a Phase-I Study.
- ClinicalTrials.gov ID
- NCT02336711
- Acronym / sponsor ID
- 2013/13MAR/117
- Conditions
- Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 13 Jan 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.
Phase I study to assess the feasibility (i.e. early toxicity) of Molecular Imaging-based Dose Escalation in HPV Negative Patients With Locally Advanced SCC of the Oropharynx.
Detailed description
The objective is to assess the feasibility (i.e. early toxicity) of an adaptive dose escalation through 18F-FDG-PET-based dose painting by numbers in 10 HPV negative patients with locally advanced squamous cell carcinoma of the oropharynx. Treatment will be delivered with Helical Tomotherapy® or volumetric-modulated arc therapy (VMAT). Dose adaptation will be performed at 2 time-points with per-treatment 18F-FDG-PET/CT scans.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose escalation | Experimental | Radiation: dose escalationDose escalation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients older than 18 years
- Patients with squamous cell carcinoma of the oropharynx, HPV-negative (p16 assay)
- T size of 3 cm or more in greatest dimension with the exclusion of tumor with bone infiltration
- N0, N1, N2a, N2b node (AJCC/UICC 7th edition)
- No distant metastasis
Key exclusion criteria (6 listed)
- Patients with induction chemotherapy will not be eligible
- Previous or concurrent history of cancer, except basal cell skin carcinoma
- Second primary tumor at the time of diagnosis
- Previous treatment with surgery, radiotherapy or chemotherapy for head and neck malignancy
- Any evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, cardiac, hepatic or renal disease), or psychological disorder
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 |
|---|---|---|
| dose escalationmolecular imaging based radiotherapy dose escalation | Radiation | Dose escalation |
Primary outcome
Acute toxicity
Time frame: up to 3 months following the completion of radiotherapy
4 secondary outcomes
Primary tumor control probability
Time frame: at 1 and 2 years
Late toxicity
Time frame: at 1 and 2 years
Progression-free survival
Time frame: at 1 and 2 years
Overall survival
Time frame: at 1 and 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2016.
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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.
Vincent Grégoire, MD, PhD principal investigator
Department of Radiation Oncology, and Center for Molecular Imaging, Radiotherapy and Oncology (MIRO), Institut de Recherche Expérimentale et Clinique (IREC), Université catholique de Louvain, St-Luc University Hospital, Brussels, Belgium
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dose escalation in people with Head and Neck Cancer, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain 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 8 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 3 Jun 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincent Grégoire, MD, PhD (+ 32-2-7645431, vincent.gregoire@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute toxicity (time frame: up to 3 months following the 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 3 Jun 2016.