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

Further Study Details: 

Primary Outcomes: Stage III NSCLC patients upstaged by PET
Secondary Outcomes: Overall survival; Impact of PET on radiation treatment planning; Prognostic ability of PET Standard Uptake Value; Number of patients downstaged by PET
Expected Total Enrollment:  400

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Stage IV NSCLC (by conventional staging).
2. Small cell lung cancer.
3. Poor performance status ECOG 3-4.
4. Poor pulmonary function precluding radical radiation therapy (Adequate pulmonary reserve for radical radiation therapy. Pulmonary function tests should have FEV1 > 1.0 liter or > 40% predicted, DLCO > 45 % and/or predicted contralateral FEV1 > 800 cc based on quantitative ventilation perfusion lung scan).
5. Significant concurrent medical problems (e.g. Uncontrolled diabetes, active cardiac problems, significant chronic obstructive pulmonary disease).
6. Insulin dependent diabetic where requirements for PET imaging may be problematic.
7. Unable to lie supine for at least 30 minutes in radiation treatment position for imaging with PET.
8. Failure to provide informed consent.
9. Previous PET scan relating to recent cancer diagnosis prior to entry into study.
10. Pregnant or lactating females.
11. Prior thoracic radiation.
12. Prior malignancy within 3 years from randomization (except nonmelanotic skin cancer or carcinoma in situ of the cervix).
13. 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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00136864

Andrea Ling, B.Sc.      905-527-2299  Ext. 42650    linga@mcmaster.ca
Laura Bonilla, M.Sc.      905-527-2299  Ext. 42610    bonilla@mcmaster.ca

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

Study chairs or principal investigators

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

Study ID Numbers:  CTA-Control-087276
Last Updated:  August 26, 2005
Record first received:  August 25, 2005
ClinicalTrials.gov Identifier:  NCT00136864
Health Authority: Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-08-30