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CompletedNCT00136864Updated Nov 18, 2011

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

A Phase 3 interventional study of PET Diagnostic Imaging in Non-Small-Cell Lung Carcinoma, sponsored by Ontario Clinical Oncology Group (OCOG). Completed at 5 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-11-18.

Sponsored by Ontario Clinical Oncology Group (OCOG) · Phase 3, Interventional, and Diagnostic

Phase
Phase 3
Study type
Interventional
Enrollment
310
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Non-Small-Cell Lung Carcinoma

Keywords

  • Positron-Emission Tomography
  • PET Scan
  • Non-Small-Cell Lung Carcinoma
  • Diagnosis
  • Radiation Oncology
  • Lung Cancer
  • Randomized Controlled Trial
  • Oncology
  • Radiation Planning
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 310 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Ontario Clinical Oncology Group (OCOG) is the lead sponsor of 56 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
05

Study design

Phase
Phase 3
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
310 participants (actual)

Study arms

  • Experimental
    1

    PET Imaging

    Procedure: PET Diagnostic Imaging

  • No intervention
    2

    Standard Imaging

Interventions

  • ProcedurePET Diagnostic Imaging

    Patients in the PET group will undergo the standard diagnostic tests plus PET to determine those suitable for combined modality therapy

06

What researchers measure

Primary outcomes

  1. Stage III NSCLC patients upstaged by PET

    Time frame: 2 years

Secondary outcomes

  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

07

Study locations

5 sites
  • Juravinski Cancer Centre
    Hamilton, Ontario L8V 5C2, Canada
  • London Regional Cancer Centre
    London, Ontario N6A 4L6, Canada
  • Ottawa Hospital Regional Cancer Centre
    Ottawa, Ontario K1H 1C4, Canada
  • Toronto-Sunnybrook Odette Regional Cancer Centre
    Toronto, Ontario M4N 3M5, Canada
  • Princess Margaret Hospital
    Toronto, Ontario M5G 2M9, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00136864
Lead sponsor
Ontario Clinical Oncology Group (OCOG)
Collaborators
Ontario Ministry of Health and Long Term Care
Responsible party
Sponsor
First posted
Aug 29, 2005
Start date
Aug 2004
Primary completion
Nov 2009
Completion
Sep 2011
Last update
Nov 18, 2011

Study contacts

Yee C Ung, MD
study chair · Toronto Sunnybrook Regional Cancer Centre
Mark N Levine, MD
principal investigator · Ontario Clinical Oncology Group (OCOG)
William Evans, MD
principal investigator · Juravinski Cancer Centre

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.

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