Primary Non-operated Squamous Cell Carcinoma of Oral CavityPhase 2C-ART-2NCT01341535
Comparison of Adaptive Dose Painting by Numbers With Standard Radiotherapy for Head and Neck Cancer.
A Phase 2 study testing Adaptive dose-painting-by-numbers and standard intensity-modulated radiotherapy (IMRT) 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
The investigators hypothesize that treatment adaptation to biological and anatomical changes, occurring during treatment, can increase the chance of cure at minimized or equal radiation-induced toxicity in head and neck cancer patients. 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?
- Adaptive dose-painting-by-numbers and standard intensity-modulated radiotherapy (IMRT)
- 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
- Sep 2011to 15 Jul 2021
- 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 oral cavity, oropharynx, hypopharynx or larynx
- Primary unresectable tumor and/or patients that refused surgery
- Stages T1-4; T3-4 N0 or T(any) N1-3 for glottic cancer
- Multidisciplinary decision of curative radiotherapy or radiochemotherapy
- Karnofsky performance status >= 70 %
- Age >= 18 years old
- Informed consent obtained, signed and dated before specific protocol procedures
Who cannot join
- High risk Human Papilloma Virus (HPV)
- Treatment combined with brachytherapy
- Prior irradiation to the head and neck region
- 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 for at least 5 years.
- Distant metastases
- Pregnant or lactating women
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- Creatinine clearance (Cockcroft-Gault) =< 60 mL/min
- 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
Department of Radiotherapy, University Hospital Ghent
Ghent, 9000
Clinique & Materinité Sainte Elisabeth
Namur
About this study
Official title: A Two-arm Phase II Randomized Study, Comparing Adaptive Biological Imaging - Voxel Intensity - Based Radiotherapy (Adaptive Dose Escalation) Versus Standard Radiotherapy for Head and Neck Cancer.
The investigators hypothesize that treatment adaptation to biological and anatomical changes, occurring during treatment, can increase the chance of cure at minimized or equal radiation-induced toxicity in head and neck cancer patients. This trial compares standard intensity-modulated radiotherapy (IMRT), using only pre-treatment planning 18F-2-fluoro-2-deoxy-D-glucose positron emission tomography to adaptive 18F-2-fluoro-2-deoxy-D-glucose positron emission tomography voxel intensity based IMRT or volumetric-modulated arc therapy (VMAT) using repetitive per-treatment planning 18F-2-fluoro-2-deoxy-D-glucose positron emission tomography for head and neck cancer.
- 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
- Adaptive dose-painting-by-numbers, standard intensity-modulated radiotherapy (IMRT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive dose-painting-by-numbersRadiation
Adaptive dose escalation by dose-painting-by-numbers.
standard intensity-modulated radiotherapy (IMRT)Radiation
Standard radiotherapy for head and neck cancer.
| Study group | Role | What they receive |
|---|---|---|
| adaptive DPBN | Experimental | This patient group will be treated by adaptive dose-painting-by-numbers, while patients in the control arm will receive standard treatment.
Patients will have a 50 % chance of being allocated to the experimental arm and a 50 % chance of being allocated to the control arm. Receives: Radiation: Adaptive dose-painting-by-numbers |
| standard IMRT | Active comparator | This patient group will be treated by standard intensity-modulated radiotherapy (IMRT), while patients in the experimental arm will receive adaptive dose-painting-by-numbers.
Patients will have a 50 % chance of being allocated to the experimental arm and a 50 % chance of being allocated to the control arm. Receives: Radiation: standard intensity-modulated radiotherapy (IMRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To obtain 25 % increase in local control at 1 year with adaptive dose escalation comparing to standard treatment.
18F-FDG-PET/CT scans will be performed.
Measured: at 1 year
Secondary outcomes (7)
Regional (elective neck) and distant control.
18F-FDG-PET/CT scans will be performed.
Measured: after 1 year
Topography of local and/or regional relapse.
18F-FDG-PET/CT scans will be performed during the first year post-treatment time point of local and/or regional relapse
Measured: during the first year post-treatment
Tumor response
18F-FDG-PET/CT scans will be performed
Measured: 3 months post-treatment
Acute toxicity
Measured: up to 12 months of follow-up
Overall disease-specific, disease-free survival.
Measured: at 1 year
Late toxicity
Measured: up to 12 months of follow-up
Time point of local and/or regional relapse.
18F-FDG-PET/CT scans will be performed.
Measured: during the first year post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2011 (estimated)
- Study startSep 2011
- Primary completion31 Oct 2017
- Study completion15 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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, Ph.D., M.D., Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01341535
- Sponsor's protocol ID
- 2010/567
- Acronym
- C-ART-2
- Status last verified
- Dec 2022
- First submitted
- 11 Apr 2011
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
De Bruycker A, De Neve W, Daisne JF, Vercauteren T, De Gersem W, Olteanu L, Berwouts D, Deheneffe S, Madani I, Goethals I, Duprez F. Disease Control and Late Toxicity in Adaptive Dose Painting by Numbers Versus Nonadaptive Radiation Therapy for Head and Neck Cancer: A Randomized Controlled Phase 2 Trial. Int J Radiat Oncol Biol Phys. 2024 Oct 1;120(2):516-527. doi: 10.1016/j.ijrobp.2024.01.012. Epub 2024 Feb 21.
PubMed 38387811
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-arm Phase II Randomized Study, Comparing Adaptive Biological Imaging - Voxel Intensity - Based Radiotherapy (Adaptive Dose Escalation) Versus Standard Radiotherapy for Head and Neck Cancer.
- ClinicalTrials.gov ID
- NCT01341535
- Acronym / sponsor ID
- C-ART-2 / 2010/567
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Sep 2011 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 25 Apr 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.
The investigators hypothesize that treatment adaptation to biological and anatomical changes, occurring during treatment, can increase the chance of cure at minimized or equal radiation-induced toxicity in head and neck cancer patients. This trial compares standard intensity-modulated radiotherapy (IMRT), using only pre-treatment planning 18F-2-fluoro-2-deoxy-D-glucose positron emission tomography to adaptive 18F-2-fluoro-2-deoxy-D-glucose positron emission tomography voxel intensity based IMRT or volumetric-modulated arc therapy (VMAT) using repetitive per-treatment planning 18F-2-fluoro-2-deoxy-D-glucose positron emission tomography for head and neck cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| adaptive DPBN | Experimental | Radiation: Adaptive dose-painting-by-numbersThis patient group will be treated by adaptive dose-painting-by-numbers, while patients in the control arm will receive standard treatment. Patients will have a 50 % chance of being allocated to the experimental arm and a 50 % chance of being allocated to the control arm. |
| standard IMRT | Active comparator | Radiation: standard intensity-modulated radiotherapy (IMRT)This patient group will be treated by standard intensity-modulated radiotherapy (IMRT), while patients in the experimental arm will receive adaptive dose-painting-by-numbers. Patients will have a 50 % chance of being allocated to the experimental arm and a 50 % chance of being allocated to the control arm. |
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 oral cavity, oropharynx, hypopharynx or larynx
- Primary unresectable tumor and/or patients that refused surgery
- Stages T1-4; T3-4 N0 or T(any) N1-3 for glottic cancer
- Multidisciplinary decision of curative radiotherapy or radiochemotherapy
- Karnofsky performance status >= 70 %
Key exclusion criteria (9 listed)
- High risk Human Papilloma Virus (HPV)
- Treatment combined with brachytherapy
- Prior irradiation to the head and neck region
- 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 for at least 5 years.
- Distant metastases
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 |
|---|---|---|
| Adaptive dose-painting-by-numbersAdaptive dose escalation by dose-painting-by-numbers. | Radiation | adaptive DPBN |
| standard intensity-modulated radiotherapy (IMRT)Standard radiotherapy for head and neck cancer. | Radiation | standard IMRT |
Primary outcome
To obtain 25 % increase in local control at 1 year with adaptive dose escalation comparing to standard treatment.
Time frame: at 1 year
18F-FDG-PET/CT scans will be performed.
7 secondary outcomes
Regional (elective neck) and distant control.
Time frame: after 1 year
Topography of local and/or regional relapse.
Time frame: during the first year post-treatment
Tumor response
Time frame: 3 months post-treatment
Acute toxicity
Time frame: up to 12 months of follow-up
Overall disease-specific, disease-free survival.
Time frame: at 1 year
Late toxicity
Time frame: up to 12 months of follow-up
Time point of local and/or regional relapse.
Time frame: during the first year post-treatment
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 14 Dec 2022.
- Derived from this study: PubMed 38387811De Bruycker A, De Neve W, Daisne JF, Vercauteren T, De Gersem W, Olteanu L, Berwouts D, Deheneffe S, Madani I, Goethals I, Duprez F. Disease Control and Late Toxicity in Adaptive Dose Painting by Numbers Versus Nonadaptive Radiation Therapy for Head and Neck Cancer: A Randomized Controlled Phase 2 Trial. Int J Radiat Oncol Biol Phys. 2024 Oct 1;120(2):516-527. doi: 10.1016/j.ijrobp.2024.01.012. Epub 2024 Feb 21.
- 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, Ph.D., M.D. 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 Adaptive dose-painting-by-numbers and standard intensity-modulated radiotherapy (IMRT) 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 9 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 14 Dec 2022. 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?
To obtain 25 % increase in local control at 1 year with adaptive dose escalation comparing to standard treatment. (time frame: at 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01341535, which also lists 1 linked publication.
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 14 Dec 2022.