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

NCT00136864 | Completed Phase 3 DMC

• 1 other identifier: CTA-Control-087276
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 5

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

Outcome Measures

Primary Outcomes (1)

• Stage III NSCLC patients upstaged by PET

  2 years

Secondary Outcomes (4)

• Overall survival

  2 years

• Impact of PET on radiation treatment planning

  2 years

• Prognostic ability of PET standard uptake value

  2 years

• Number of patients downstaged by PET

  2 years

Study Arms (2)

1

EXPERIMENTAL

PET Imaging

Procedure: PET Diagnostic Imaging

2

NO INTERVENTION

Standard Imaging

Interventions

PET Diagnostic Imaging PROCEDURE

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ontario Clinical Oncology Group (OCOG): lead
• Ontario Ministry of Health and Long Term Care: collaborator

Study Sites (5)

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

Ottawa Hospital Regional Cancer Centre

Ottawa, Ontario, K1H 1C4, Canada

Location

Toronto-Sunnybrook Odette Regional Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Disease; Lung Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yee C Ung, MD

  Toronto Sunnybrook Regional Cancer Centre

  STUDY CHAIR

• Mark N Levine, MD

  Ontario Clinical Oncology Group (OCOG)

  PRINCIPAL INVESTIGATOR

• William Evans, MD

  Juravinski Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2005
• First Posted: August 29, 2005
• Study Start: August 1, 2004
• Primary Completion: November 1, 2009
• Study Completion: September 1, 2011
• Last Updated: November 18, 2011

Record last verified: 2011-11

Locations

CA (5)