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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00136864
Recruitment Status : Completed
First Posted : August 29, 2005
Last Update Posted : November 18, 2011
Ontario Ministry of Health and Long Term Care
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)

Brief Summary:

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 or disease Intervention/treatment Phase
Non-Small-Cell Lung Carcinoma Procedure: PET Diagnostic Imaging Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 310 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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)
Study Start Date : August 2004
Actual Primary Completion Date : November 2009
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
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

No Intervention: 2
Standard Imaging

Primary Outcome Measures :
  1. Stage III NSCLC patients upstaged by PET [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 2 years ]
  2. Impact of PET on radiation treatment planning [ Time Frame: 2 years ]
  3. Prognostic ability of PET standard uptake value [ Time Frame: 2 years ]
  4. Number of patients downstaged by PET [ Time Frame: 2 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00136864

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Canada, Ontario
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 1C4
Toronto-Sunnybrook Odette Regional Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
Ontario Clinical Oncology Group (OCOG)
Ontario Ministry of Health and Long Term Care
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Study Chair: Yee C Ung, MD Toronto Sunnybrook Regional Cancer Centre
Principal Investigator: Mark N Levine, MD Ontario Clinical Oncology Group (OCOG)
Principal Investigator: William Evans, MD Juravinski Cancer Centre
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Responsible Party: Ontario Clinical Oncology Group (OCOG) Identifier: NCT00136864    
Other Study ID Numbers: CTA-Control-087276
First Posted: August 29, 2005    Key Record Dates
Last Update Posted: November 18, 2011
Last Verified: November 2011
Keywords provided by Ontario Clinical Oncology Group (OCOG):
Positron-Emission Tomography
PET Scan
Non-Small-Cell Lung Carcinoma
Radiation Oncology
Lung Cancer
Randomized Controlled Trial
Radiation Planning
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms