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

NCT00136864 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2011-11-18

No results posted yet for this 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.

Conditions

  • Non-Small-Cell Lung Carcinoma

Interventions

PROCEDURE

PET Diagnostic Imaging

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

Sponsors & Collaborators

  • Ontario Ministry of Health and Long Term Care

    collaborator OTHER_GOV
  • Ontario Clinical Oncology Group (OCOG)

    lead OTHER

Principal Investigators

  • Yee C Ung, MD · Toronto Sunnybrook Regional Cancer Centre

  • Mark N Levine, MD · Ontario Clinical Oncology Group (OCOG)

  • William Evans, MD · Juravinski Cancer Centre

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-08-31
Primary Completion
2009-11-30
Completion
2011-09-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00136864 on ClinicalTrials.gov