Positron Emission Tomography (PET) Imaging in Stage III Non-small Cell Lung Cancer (PET START Trial) - Full Text View

Sponsors and Collaborators:	Ontario Clinical Oncology Group (OCOG) Ontario Ministry of Health and Long Term Care
Information provided by:	Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier:	NCT00136864

Purpose

Locally advanced non-small cell lung cancer, NSCLC, (Stage III) is potentially curable with aggressive combined modality therapy (chemotherapy and radiation). Conventional imaging can only evaluate gross anatomic abnormalities but functional imaging with positron emission tomography (PET) may more accurately identify patients who will benefit from aggressive combined modality therapy.

This prospective randomized clinical trial will enroll 400 patients that have undergone conventional staging for lung cancer and have been found to have Stage III NSCLC. The patients will then be randomized to either standard combined modality therapy for Stage III NSCLC or to PET imaging prior to combined modality therapy with curative intent. Based on the PET findings, patients will either be suitable for combined modality therapy with curative intent or not.

Condition	Intervention	Phase
Non-Small-Cell Lung Carcinoma	Procedure: PET Diagnostic Imaging	Phase III

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	The Impact of Positron Emission Tomography (PET) Imaging in Stage III Non-small Cell Lung Cancer: A Prospective Randomized Clinical Trial (PET START Trial)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer Radiation Therapy

U.S. FDA Resources

Further study details as provided by Ontario Clinical Oncology Group (OCOG):

Primary Outcome Measures:

Stage III NSCLC patients upstaged by PET [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Impact of PET on radiation treatment planning [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Prognostic ability of PET standard uptake value [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Number of patients downstaged by PET [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	August 2004
Estimated Study Completion Date:	May 2011
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental PET Imaging	Procedure: PET Diagnostic Imaging Patients in the PET group will undergo the standard diagnostic tests plus PET to determine those suitable for combined modality therapy
2: No Intervention Standard Imaging

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histological or cytological evidence of NSCLC. Must have documented pathology report with histology indicated (e.g. squamous, adenocarcinoma, large cell, NSCLC not otherwise specified).
Stage III (mediastinal node positive) NSCLC based on conventional staging (e.g. computed tomography [CT] scan of chest and upper abdomen, CT or magnetic resonance imaging [MRI] of brain, bone scan).
Suitable for combined modality (chemotherapy and radiation) therapy or radical radiation therapy or trimodality therapy (chemotherapy, radiation and surgery).

Exclusion Criteria:

Stage IV NSCLC (by conventional staging).
Small cell lung cancer.
Poor performance status Eastern Cooperative Oncology Group (ECOG) 3-4.
Poor pulmonary function precluding radical radiation therapy (Adequate pulmonary reserve for radical radiation therapy. Pulmonary function tests should have forced expiratory volume in 1 second (FEV1) > 1.0 liter or > 40% predicted, diffusing capacity of the lung for carbon monoxide (DLCO) > 45% and/or predicted contralateral FEV1 > 800 cc based on quantitative ventilation perfusion lung scan).
Significant concurrent medical problems (e.g. uncontrolled diabetes, active cardiac problems, significant chronic obstructive pulmonary disease).
Insulin dependent diabetic where requirements for PET imaging may be problematic.
Unable to lie supine for at least 30 minutes in radiation treatment position for imaging with PET.
Failure to provide informed consent.
Previous PET scan relating to recent cancer diagnosis prior to entry into study.
Pregnant or lactating females.
Prior thoracic radiation.
Prior malignancy within 3 years from randomization (except nonmelanotic skin cancer or carcinoma in situ of the cervix).
Administered more than two cycles of chemotherapy prior to radical radiation therapy or concurrent chemoradiation (as part of induction or sequential chemotherapy prior to randomization) for the current malignancy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00136864

Locations

Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Toronto-Sunnybrook Odette Regional Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 1C4

Sponsors and Collaborators

Ontario Clinical Oncology Group (OCOG)

Ontario Ministry of Health and Long Term Care

Investigators

Study Chair:	Yee C Ung, MD	Toronto Sunnybrook Regional Cancer Centre
Principal Investigator:	Mark N Levine, MD	Ontario Clinical Oncology Group
Principal Investigator:	William Evans, MD	Juravinski Cancer Centre

More Information

No publications provided

Responsible Party:	Ontario Clinical Oncology Group ( Dr. Mark Levine )
Study ID Numbers:	CTA-Control-087276
Study First Received:	August 25, 2005
Last Updated:	July 23, 2009
ClinicalTrials.gov Identifier:	NCT00136864 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Ontario Clinical Oncology Group (OCOG):

Positron-Emission Tomography
PET Scan
Non-Small-Cell Lung Carcinoma
Diagnosis
Radiation Oncology

Lung Cancer
Randomized Controlled Trial
Oncology
Radiation Planning

Study placed in the following topic categories:

Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

Non-small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Respiratory Tract Diseases

Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on September 11, 2009