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
Cancer of the Head and Neck	Procedure: PET scan	Phase III

Further Study Details: 

Primary Outcomes: Ability of PET compared to CT in identifying the presence of tumour in neck nodes
Secondary Outcomes: - Tumour at the primary site 8-10 weeks following radiation; - The change in PET signal (standard uptake value); - Local recurrence, distant metastases and survival
Expected Total Enrollment:  400

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   -   80 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

All of the following criteria must be satisfied:

1. Histological evidence of squamous cell carcinoma of the head & neck (T1-T4 arising in either the oral cavity, larynx & pharynx – except Nasopharyngeal carcinoma).
2. Presence of advanced N2 or N3 neck disease.

3. Planned for primary curative radiation therapy (± chemotherapy) followed by neck dissection eight to twelve weeks after completion of treatment.

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Exclusion Criteria:

1. Age > 80 years
2. Presence of distant metastasis
3. Recurrent tumour
4. Prior neo-adjuvant chemotherapy
5. Previous radiation therapy to intended treatment volumes
6. Other active malignancy
7. Surgically inoperable neck disease
8. Unable to remain supine for 60 minutes
9. Unfit to undergo general anesthetic or neck dissection for medical reasons
10. Known hypersensitivity to CT contrast
11. Pregnancy

Please refer to this study by ClinicalTrials.gov identifier  NCT00147472

Laura R Bonilla, M.Sc., MCPM      905 544 5426  Ext. 42610    bonilla@mcmaster.ca
Andrea Ling, B.Sc.      905 544 5426  Ext. 42650    linga@mcmaster.ca

Canada, Ontario
      Princess Margaret Hospital, Toronto,  Ontario,  M5G 2M9,  Canada; Recruiting
      London Regional Cancer Centre, London,  Ontario,  N6A 4L6,  Canada; Recruiting
      Juravinski Cancer Centre, Hamilton,  Ontario,  L8V 5C2,  Canada; Recruiting
      Ottawa Regional Cancer Centre, Ottawa,  Ontario,  K1H 1C4,  Canada; Recruiting

Study chairs or principal investigators

John Waldron, MD,  Study Chair,  Princess Margaret Hospital   
Ralph Gilbert, MD,  Principal Investigator,  Princess Margaret Hospital   
Libni Eapen, MD,  Principal Investigator,  Ottawa Regional Cancer Centre   
Anne Keller, MD,  Principal Investigator,  Princess Margaret Hospital   
Mark N Levine, MD,  Principal Investigator,  Ontario Clinical Oncology Group   
Bayardo Perez-Ordonez, MD,  Principal Investigator,  Princess Margaret Hospital   
Robin Roberts, M.Mat,  Principal Investigator,  McMaster University   

Study ID Numbers:  CTA-Control-088421
Last Updated:  September 9, 2005
Record first received:  September 1, 2005
ClinicalTrials.gov Identifier:  NCT00147472
Health Authority: Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-09-13