Cancer of the Head and NeckPhase 3NCT00147472
Positronic Emission Tomography (PET) Imaging in Post Radiation Evaluation of Head and Neck Tumours (PET PREVENT Trial)
A Phase 3 study testing PET scan in addition to conventional CT imaging in people with Cancer of the Head and Neck, run by Ontario Clinical Oncology Group (OCOG) at 4 sites in Canada.
Trial summary
The purpose of this trial is to determine the ability of positron emission tomography (PET) to detect residual cancer in neck lymph nodes of patients following curative treatment with radiation therapy for squamous cell cancer arising in the head and neck. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of the Head and Neck
- What is being tested?
- PET scan in addition to conventional CT imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 4 sitesCanada
- Study dates
- May 2004to May 2011
- Phase
- Phase 3
- 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
- All of the following criteria must be satisfied:
- Histological evidence of squamous cell carcinoma of the head \& neck (T1-T4 arising in either the oral cavity, larynx \& pharynx, except Nasopharyngeal carcinoma);OR patients with histological evidence of squamous cell carcinoma metastatic to the neck and an unknown primary site after conventional workup without any of the following: i). Clinically suspected skin primary or previous diagnosis of skin cancer arising in the head and neck area; ii). Patients of Asian or African decent -possible nasopharynx primary; iii). Patients whose malignant adenopathy is confined to zone V -possible nasopharynx primary; and iv). Patients whose malignant adenopathy is confined to zone IV (supraclavicular)-possible lung primary.
- Presence of advanced N2 or N3 neck disease.
- Planned for primary curative radiation therapy (± chemotherapy) followed by neck dissection eight to twelve weeks after completion of treatment.
Who cannot join
- Presence of distant metastasis
- Recurrent tumour
- Prior neo-adjuvant chemotherapy
- Previous radiation therapy to intended treatment volumes
- Other active malignancy
- Surgically inoperable neck disease
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- Unable to remain supine for 60 minutes
- Unfit to undergo general anesthetic or neck dissection for medical reasons
- Known hypersensitivity to CT contrast
- Pregnancy
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
London Regional Cancer Centre
London, Ontario, N6A 4L6
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 1C4
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
About this study
Official title: A Prospective Cohort Study to Determine the Sensitivity of Positron Emission Tomography (PET) in Detecting Metastatic Cancer in Neck Lymph Nodes in Patients With Squamous Cell Head & Neck Cancer Managed With Primary Radiation Therapy
The purpose of this trial is to determine the ability of positron emission tomography (PET) to detect residual cancer in neck lymph nodes of patients following curative treatment with radiation therapy for squamous cell cancer arising in the head and neck.
Patients with head and neck cancer (HNC) undergo treatment of curative intent; patients who are node positive (N2 N3 stages) undergo standard management which includes post-radiation planned neck dissection but two thirds of patients end up not having evidence of residual disease in neck dissection specimens; these patients could have avoided surgery. However, currently used standard tests, like computed tomography (CT) and/or magnetic resonance imaging (MRI) cannot reliably predict who is post-radiation disease free.
Read the detailed description
PET-Fluorodeoxyglucose scanning is an imaging test based on the increased uptake of radiolabelled glucose by tumour cells. PET might detect neck tumours better than other imaging tests. This is a cohort study in which patients with N2 N3 squamous cell carcinoma of the head and neck undergo a PET and a CT scan at baseline and then post-radiation therapy and chemotherapy. Then, they undergo neck dissection surgery. The PET and CT results are compared with the presence or absence of tumours in the neck nodes. If PET is sufficiently accurate in predicting the presence or absence of tumours in the neck nodes, then a neck dissection could be avoided.
- Conditions
- Cancer of the Head and Neck
- Being tested
- PET scan in addition to conventional CT imaging
- Keywords
- Head and neck, Cancer, Diagnosis, Fluorodeoxyglucose, Positron-Emission Tomography, PET, Oncology
- Medical subject headings
- Head and Neck Neoplasms, Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET scan in addition to conventional CT imagingOther
Also called FDG PET
PET scans, Pre and post radiation treatment
| Study group | Role | What they receive |
|---|---|---|
| PET | Other | All patients receive PET scan and conventional CT imaging. Receives: Other: PET scan in addition to conventional CT imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of PET compared to CT in identifying the presence of tumour in neck nodes
Measured: 2 years
Secondary outcomes (3)
Tumour at the primary site 8-10 weeks following radiation;
Measured: 2 years
The change in PET signal (standard uptake value;
Measured: 2 years
Local recurrence, distant metastases and survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startMay 2004
- Primary completionAug 2009
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of the Head and NeckStudies 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 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care
- Responsible party
- Sponsor
- Investigators
- John Waldron, MD, Study chair, Princess Margaret Hospital, CanadaRalph Gilbert, MD, Principal investigator, Princess Margaret Hospital, CanadaLibni Eapen, MD, Principal investigator, Ottawa Regional Cancer CentreAnne Keller, MD, Principal investigator, Princess Margaret Hospital, CanadaMark N Levine, MD, Principal investigator, Ontario Clinical Oncology Group (OCOG)Bayardo Perez-Ordonez, MD, Principal investigator, Princess Margaret Hospital, CanadaChu-Shu Gu, M.Sc., Principal investigator, Ontario Clinical Oncology Group (OCOG)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00147472
- Sponsor's protocol ID
- CTA-Control-088421
- Status last verified
- Jun 2012
- First submitted
- 1 Sep 2005
- Last updated
- 22 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study to Determine the Sensitivity of Positron Emission Tomography (PET) in Detecting Metastatic Cancer in Neck Lymph Nodes in Patients With Squamous Cell Head & Neck Cancer Managed With Primary Radiation Therapy
- ClinicalTrials.gov ID
- NCT00147472
- Acronym / sponsor ID
- CTA-Control-088421
- Conditions
- Cancer of the Head and Neck
- Keywords
- Head and neck, Cancer, Diagnosis, Fluorodeoxyglucose, Positron-Emission Tomography, PET, Oncology
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)University, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care
- Study start
- May 2004
- Primary completion
- Aug 2009 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 7 Sep 2005 (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 purpose of this trial is to determine the ability of positron emission tomography (PET) to detect residual cancer in neck lymph nodes of patients following curative treatment with radiation therapy for squamous cell cancer arising in the head and neck.
Patients with head and neck cancer (HNC) undergo treatment of curative intent; patients who are node positive (N2 N3 stages) undergo standard management which includes post-radiation planned neck dissection but two thirds of patients end up not having evidence of residual disease in neck dissection specimens; these patients could have avoided surgery. However, currently used standard tests, like computed tomography (CT) and/or magnetic resonance imaging (MRI) cannot reliably predict who is post-radiation disease free.
Detailed description
PET-Fluorodeoxyglucose scanning is an imaging test based on the increased uptake of radiolabelled glucose by tumour cells. PET might detect neck tumours better than other imaging tests. This is a cohort study in which patients with N2 N3 squamous cell carcinoma of the head and neck undergo a PET and a CT scan at baseline and then post-radiation therapy and chemotherapy. Then, they undergo neck dissection surgery. The PET and CT results are compared with the presence or absence of tumours in the neck nodes. If PET is sufficiently accurate in predicting the presence or absence of tumours in the neck nodes, then a neck dissection could be avoided.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET | Other | Other: PET scan in addition to conventional CT imagingAll patients receive PET scan and conventional CT imaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histological evidence of squamous cell carcinoma of the head \& neck (T1-T4 arising in either the oral cavity, larynx \& pharynx, except Nasopharyngeal carcinoma);OR patients with histological evidence of squamous cell carcinoma metastatic to the neck and an unknown primary site after conventional workup without any of the following: i). Clinically suspected skin primary or previous diagnosis of skin cancer arising in the head and neck area; ii). Patients of Asian or African decent -possible nasopharynx primary; iii). Patients whose malignant adenopathy is confined to zone V -possible nasopharynx primary; and iv). Patients whose malignant adenopathy is confined to zone IV (supraclavicular)-possible lung primary.
- Presence of advanced N2 or N3 neck disease.
- Planned for primary curative radiation therapy (± chemotherapy) followed by neck dissection eight to twelve weeks after completion of treatment.
Key exclusion criteria (10 listed)
- Presence of distant metastasis
- Recurrent tumour
- Prior neo-adjuvant chemotherapy
- Previous radiation therapy to intended treatment volumes
- Other active malignancy
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 |
|---|---|---|
| PET scan in addition to conventional CT imagingAlso: FDG PETPET scans, Pre and post radiation treatment | Other | PET |
Primary outcome
Ability of PET compared to CT in identifying the presence of tumour in neck nodes
Time frame: 2 years
3 secondary outcomes
Tumour at the primary site 8-10 weeks following radiation;
Time frame: 2 years
The change in PET signal (standard uptake value;
Time frame: 2 years
Local recurrence, distant metastases and survival
Time frame: 2 years
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 22 Jun 2012.
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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.
John Waldron, MD study chair
Princess Margaret Hospital, Canada
Ralph Gilbert, MD principal investigator
Princess Margaret Hospital, Canada
Libni Eapen, MD principal investigator
Ottawa Regional Cancer Centre
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PET scan in addition to conventional CT imaging in people with Cancer of the Head and Neck, run by Ontario Clinical Oncology Group (OCOG) at 4 sites in Canada.
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 4 inclusion and 10 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 22 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Ability of PET compared to CT in identifying the presence of tumour in neck nodes (time frame: 2 years). 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 22 Jun 2012.