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Sponsors and Collaborators: |
Ontario Clinical Oncology Group (OCOG) Ontario Ministry of Health and Long Term Care |
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Information provided by: | Ontario Clinical Oncology Group (OCOG) |
ClinicalTrials.gov Identifier: | NCT00147472 |
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.
Condition | Intervention | Phase |
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Cancer of the Head and Neck |
Other: PET scan in addition to conventional CT imaging |
Phase III |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy 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 |
Estimated Enrollment: | 400 |
Study Start Date: | May 2004 |
Estimated Study Completion Date: | May 2011 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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PET
All patients receive PET scan and conventional CT imaging.
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Other: PET scan in addition to conventional CT imaging
PET scans, Pre and post radiation treatment
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
All of the following criteria must be satisfied:
Exclusion Criteria:
Canada, Ontario | |
Princess Margaret Hospital | |
Toronto, Ontario, Canada, M5G 2M9 | |
London Regional Cancer Centre | |
London, Ontario, Canada, N6A 4L6 | |
Juravinski Cancer Centre | |
Hamilton, Ontario, Canada, L8V 5C2 | |
Ottawa Regional Cancer Centre | |
Ottawa, Ontario, Canada, K1H 1C4 |
Study Chair: | John Waldron, MD | Princess Margaret Hospital, Canada |
Principal Investigator: | Ralph Gilbert, MD | Princess Margaret Hospital, Canada |
Principal Investigator: | Libni Eapen, MD | Ottawa Regional Cancer Centre |
Principal Investigator: | Anne Keller, MD | Princess Margaret Hospital, Canada |
Principal Investigator: | Mark N Levine, MD | Ontario Clinical Oncology Group |
Principal Investigator: | Bayardo Perez-Ordonez, MD | Princess Margaret Hospital, Canada |
Principal Investigator: | Chu-Shu Gu, M.Sc. | Ontario Clinical Oncology Group |
Responsible Party: | Ontario Clinical Oncology Group ( Dr Mark Levine ) |
Study ID Numbers: | CTA-Control-088421 |
Study First Received: | September 1, 2005 |
Last Updated: | April 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00147472 History of Changes |
Health Authority: | Canada: Health Canada |
Head and neck Cancer Diagnosis Fluorodeoxyglucose |
Positron-Emission Tomography PET Oncology |
Head and Neck Neoplasms Neoplasm Metastasis |
Neoplasms Neoplasms by Site Head and Neck Neoplasms |