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

NCT ID: NCT00136864

Last Updated: 2011-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 310 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-31
• Study Completion Date: 2011-09-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

1

PET Imaging

Group Type: EXPERIMENTAL

PET Diagnostic Imaging

Intervention Type: PROCEDURE

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

2

Standard Imaging

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PET Diagnostic Imaging

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ontario Ministry of Health and Long Term Care

OTHER_GOV

Sponsor Role: collaborator

Ontario Clinical Oncology Group (OCOG)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yee C Ung, MD

Role: STUDY_CHAIR

Toronto Sunnybrook Regional Cancer Centre

Mark N Levine, MD

Role: PRINCIPAL_INVESTIGATOR

Ontario Clinical Oncology Group (OCOG)

William Evans, MD

Role: PRINCIPAL_INVESTIGATOR

Juravinski Cancer Centre

Locations

Juravinski Cancer Centre

Hamilton, Ontario, Canada

London Regional Cancer Centre

London, Ontario, Canada

Ottawa Hospital Regional Cancer Centre

Ottawa, Ontario, Canada

Toronto-Sunnybrook Odette Regional Cancer Centre

Toronto, Ontario, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

CTA-Control-087276

Identifier Type: -

Identifier Source: org_study_id