Status:
COMPLETED
Positronic Emission Tomography (PET) Imaging in Post Radiation Evaluation of Head and Neck Tumours (PET PREVENT Trial)
Lead Sponsor:
Ontario Clinical Oncology Group (OCOG)
Collaborating Sponsors:
Ontario Ministry of Health and Long Term Care
Conditions:
Cancer of the Head and Neck
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 therap...
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 coho...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Presence of distant metastasis
- Recurrent tumour
- Prior neo-adjuvant chemotherapy
- Previous radiation therapy to intended treatment volumes
- Other active malignancy
- Surgically inoperable neck disease
- Unable to remain supine for 60 minutes
- Unfit to undergo general anesthetic or neck dissection for medical reasons
- Known hypersensitivity to CT contrast
- Pregnancy
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00147472
Start Date
May 1 2004
End Date
May 1 2011
Last Update
June 22 2012
Active Locations (4)
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1
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
2
London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
3
Ottawa Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 1C4
4
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9