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

Primary Purpose

Non-Small-Cell Lung Carcinoma

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
PET Diagnostic Imaging
Sponsored by
Ontario Clinical Oncology Group (OCOG)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Non-Small-Cell Lung Carcinoma focused on measuring Positron-Emission Tomography, PET Scan, Non-Small-Cell Lung Carcinoma, Diagnosis, Radiation Oncology, Lung Cancer, Randomized Controlled Trial, Oncology, Radiation Planning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Juravinski Cancer Centre
  • London Regional Cancer Centre
  • Ottawa Hospital Regional Cancer Centre
  • Toronto-Sunnybrook Odette Regional Cancer Centre
  • Princess Margaret Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

PET Imaging

Standard Imaging

Outcomes

Primary Outcome Measures

Stage III NSCLC patients upstaged by PET

Secondary Outcome Measures

Overall survival
Impact of PET on radiation treatment planning
Prognostic ability of PET standard uptake value
Number of patients downstaged by PET

Full Information

First Posted
August 25, 2005
Last Updated
November 17, 2011
Sponsor
Ontario Clinical Oncology Group (OCOG)
Collaborators
Ontario Ministry of Health and Long Term Care
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1. Study Identification

Unique Protocol Identification Number
NCT00136864
Brief Title
Positron Emission Tomography (PET) Imaging in Stage III Non-small Cell Lung Cancer (PET START Trial)
Official Title
The Impact of Positron Emission Tomography (PET) Imaging in Stage III Non-small Cell Lung Cancer: A Prospective Randomized Clinical Trial (PET START Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ontario Clinical Oncology Group (OCOG)
Collaborators
Ontario Ministry of Health and Long Term Care

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
310 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
PET Imaging
Arm Title
2
Arm Type
No Intervention
Arm Description
Standard Imaging
Intervention Type
Procedure
Intervention Name(s)
PET Diagnostic Imaging
Intervention Description
Patients in the PET group will undergo the standard diagnostic tests plus PET to determine those suitable for combined modality therapy
Primary Outcome Measure Information:
Title
Stage III NSCLC patients upstaged by PET
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
2 years
Title
Impact of PET on radiation treatment planning
Time Frame
2 years
Title
Prognostic ability of PET standard uptake value
Time Frame
2 years
Title
Number of patients downstaged by PET
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yee C Ung, MD
Organizational Affiliation
Toronto Sunnybrook Regional Cancer Centre
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mark N Levine, MD
Organizational Affiliation
Ontario Clinical Oncology Group (OCOG)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William Evans, MD
Organizational Affiliation
Juravinski Cancer Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
London Regional Cancer Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Ottawa Hospital Regional Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1C4
Country
Canada
Facility Name
Toronto-Sunnybrook Odette Regional Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

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

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