Status:
COMPLETED
Positron Emission Tomography (PET) Imaging in Stage III Non-small Cell Lung Cancer (PET START Trial)
Lead Sponsor:
Ontario Clinical Oncology Group (OCOG)
Collaborating Sponsors:
Ontario Ministry of Health and Long Term Care
Conditions:
Non-Small-Cell Lung Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 gr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT00136864
Start Date
August 1 2004
End Date
September 1 2011
Last Update
November 18 2011
Active Locations (5)
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1
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
2
London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
3
Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 1C4
4
Toronto-Sunnybrook Odette Regional Cancer Centre
Toronto, Ontario, Canada, M4N 3M5