Squamous Cell CarcinomaPhase 1NCT01208883
A Feasibility Study On Continuous Adaptive [18f]Fdg-Pet-Guided Radiotherapy For Head and Neck Cancer
A Phase 1 study testing repetitive per-treatment [18F]FDG-PET for treatment adaptation in people with Squamous Cell Carcinoma, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Treatment adaptation to biological and anatomical changes occurring during treatment can increase the chance of cure at minimized 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
- Squamous Cell Carcinoma
- What is being tested?
- repetitive per-treatment [18F]FDG-PET for treatment adaptation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2010to Mar 2012
- Phase
- Phase 1
- 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 or larynx.
- Primary unresectable tumor and/or patients refused surgery.
- Stage T1-4; T3-4 N0 or Tany N1-3 for cancer of the glottis.
- 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
- Treatment combined with brachytherapy.
- Prior irradiation to the head and neck region.
- Distant metastases.
- Second primary tumors that are not under control
- Pregnant or lactating women.
- Creatinine clearance (Cockcroft-Gault) ≤ 60 mL/min before treatment.
Show all 9Show fewer
- Allergy to the CT-contrast agents.
- 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
1 site in 1 country.
About this study
Official title: A FEASIBILITY STUDY ON CONTINUOUS ADAPTIVE [18F]FDG-PET-GUIDED RADIOTHERAPY FOR HEAD AND NECK CANCER
Treatment adaptation to biological and anatomical changes occurring during treatment can increase the chance of cure at minimized radiation-induced toxicity in head and neck cancer patients. This trial investigates the feasibility of using repetitive per-treatment [18F]FDG-PET acquired during treatment in adaptive [18F]FDG-PET-voxel intensity-based intensity-modulated radiotherapy (IMRT) or volumetric-modulated arc therapy (VMAT) for head and neck cancer.
- Conditions
- Squamous Cell Carcinoma
- Being tested
- repetitive per-treatment [18F]FDG-PET for treatment adaptation
- Keywords
- Primary non-operated squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx and 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.
repetitive per-treatment [18F]FDG-PET for treatment adaptationOther
repetitive per-treatment [18F]FDG-PET for treatment adaptation
| Study group | Role | What they receive |
|---|---|---|
| repetitive per-treatment [18F]FDG-PET for treatment adaptation | Experimental | Not described Receives: Other: repetitive per-treatment [18F]FDG-PET for treatment adaptation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess volume changes of the targets and organs at risk as detected by repetitive per-treatment [18F]FDG-PET/CT.
Measured: at time of per-treatment [18F]FDG-PET/CT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionOct 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell CarcinomaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wilfried De Neve, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01208883
- Sponsor's protocol ID
- 2010/510
- Status last verified
- Jan 2014
- First submitted
- 23 Sep 2010
- Last updated
- 24 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A FEASIBILITY STUDY ON CONTINUOUS ADAPTIVE [18F]FDG-PET-GUIDED RADIOTHERAPY FOR HEAD AND NECK CANCER
- ClinicalTrials.gov ID
- NCT01208883
- Acronym / sponsor ID
- 2010/510
- Conditions
- Squamous Cell Carcinoma
- Keywords
- Primary non-operated squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx and larynx.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 24 Sep 2010 (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.
Treatment adaptation to biological and anatomical changes occurring during treatment can increase the chance of cure at minimized radiation-induced toxicity in head and neck cancer patients. This trial investigates the feasibility of using repetitive per-treatment [18F]FDG-PET acquired during treatment in adaptive [18F]FDG-PET-voxel intensity-based intensity-modulated radiotherapy (IMRT) or volumetric-modulated arc therapy (VMAT) for head and neck cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| repetitive per-treatment [18F]FDG-PET for treatment adaptation | Experimental | Other: repetitive per-treatment [18F]FDG-PET for treatment adaptation |
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 or larynx.
- Primary unresectable tumor and/or patients refused surgery.
- Stage T1-4; T3-4 N0 or Tany N1-3 for cancer of the glottis.
- Multidisciplinary decision of curative radiotherapy or radiochemotherapy.
- Karnofsky performance status ≥70%.
Key exclusion criteria (9 listed)
- Treatment combined with brachytherapy.
- Prior irradiation to the head and neck region.
- Distant metastases.
- Second primary tumors that are not under control
- Pregnant or lactating women.
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 |
|---|---|---|
| repetitive per-treatment [18F]FDG-PET for treatment adaptationrepetitive per-treatment [18F]FDG-PET for treatment adaptation | Other | repetitive per-treatment [18F]FDG-PET for treatment adaptation |
Primary outcome
To assess volume changes of the targets and organs at risk as detected by repetitive per-treatment [18F]FDG-PET/CT.
Time frame: at time of per-treatment [18F]FDG-PET/CT
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 24 Jan 2014.
- website University Hospital Ghent, BelgiumLink provided by the sponsor.
Related trials for Squamous Cell Carcinoma
RecruitingPhase 2
Adebrelimab ±Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Unresectable Locally Advanced ESCC
Esophageal Squamous Cell Carcinoma, Immunotherapy
Active, not recruitingPhase 3
A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer
Non-small Cell Lung Cancer Stage IV
Active, not recruitingPhase 3
Testing the Timing of Pembrolizumab Alone or With Chemotherapy as First Line Treatment and Maintenance in Non-small Cell Lung Cancer
Lung Non-Squamous Non-Small Cell Carcinoma, Stage IIIB Lung Cancer AJCC v8
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2
Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer
Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
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, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing repetitive per-treatment [18F]FDG-PET for treatment adaptation in people with Squamous Cell Carcinoma, run by University Hospital, Ghent at 1 site 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 24 Jan 2014. 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 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 assess volume changes of the targets and organs at risk as detected by repetitive per-treatment [18F]FDG-PET/CT. (time frame: at time of per-treatment [18F]FDG-PET/CT). 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 24 Jan 2014.