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The Impact of Positron Emission Tomography (PET) Imaging in Stage III Non-small Cell Lung Cancer: A Prospective Randomized Clinical Trial (PET START Trial)

Phase 3
18 Years
Not Enrolling
Non-Small-Cell Lung Carcinoma

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Trial Information

The Impact of Positron Emission Tomography (PET) Imaging in Stage III Non-small Cell Lung Cancer: A Prospective Randomized Clinical Trial (PET START Trial)

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Stage III NSCLC patients upstaged by PET

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Yee C Ung, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Toronto Sunnybrook Regional Cancer Centre


Canada: Health Canada

Study ID:




Start Date:

August 2004

Completion Date:

September 2011

Related Keywords:

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