Clinical trial NCT00147472: Positronic Emission Tomography (PET) Imaging in Post Radiation Evaluation of Head and Neck Tumours (PET PREVENT Trial)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cancer of the Head and Neck
Keywords: Head and neck
Cancer
Diagnosis
Fluorodeoxyglucose
Positron-Emission Tomography
PET
Oncology
Lead sponsor: Ontario Clinical Oncology Group (OCOG)
Sponsor class: OTHER
Collaborators: name: Ontario Ministry of Health and Long Term Care
First posted: 2005-09-07
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 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.

Eligibility 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);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.
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.

Exclusion Criteria:

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

Primary outcomes:
measure: Ability of PET compared to CT in identifying the presence of tumour in neck nodes
timeFrame: 2 years
Secondary outcomes:
measure: Tumour at the primary site 8-10 weeks following radiation;
timeFrame: 2 years
measure: The change in PET signal (standard uptake value;
timeFrame: 2 years
measure: Local recurrence, distant metastases and survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Regional Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: Princess Margaret Hospital, Canada
name: John Waldron, MD
role: STUDY_CHAIR
affiliation: Princess Margaret Hospital, Canada
name: Ralph Gilbert, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ottawa Regional Cancer Centre
name: Libni Eapen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Princess Margaret Hospital, Canada
name: Anne Keller, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ontario Clinical Oncology Group (OCOG)
name: Mark N Levine, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Princess Margaret Hospital, Canada
name: Bayardo Perez-Ordonez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ontario Clinical Oncology Group (OCOG)
name: Chu-Shu Gu, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References: