To Evaluate the Impact of PET/CT on Radiation Treatment Planning in Relation to Changes in GTV in Stage 3 NSCLC

June 25, 2013 updated by: University of Manitoba

A Prospective Observational Study to Evaluate the Impact of PET/CT Simulation on Radiation Treatment Planning in Relation to Changes in GTV in Locally Advanced Non-small Cell Lung Cancer

Acknowledging that level I evidence already exists regarding the general beneficial impact on FDG PET in the staging and subsequent management of lung cancer the investigators postulate that fusing PET/CT data sets with RT CT simulation data sets for adult patients with conventionally/clinically assessed stage III non-small cell lung cancer will have a significant impact on GTV as well as normal tissue irradiation. This research will also estimate inter and intra-observer variability of treatment planning, relative to GTV, between and amongst radiation oncologists.

Study Overview

Status

Terminated

Conditions

Lung Cancer

Detailed Description

Primary objectives of the study:

1.To determine the impact of PET/CT fusion on gross tumor volume ( GTV ) for primary(GTVP) and nodal (GTVN) disease for each patient by comparing GTV contours using two separate data sets.

(A) GTVP CT+ ve and GTVN CT+ ve

(B) GTVP PET+ve and GTVN PET +ve

GTV will be measured and recorded in cubic centimeters for each volume.

Secondary Endpoints:

1.Normal tissue toxicity:3D conformal Computerized radiation plans will be generated for the data sets GTVP and GTVN A and B .Dose Volume Histogram (DVH) will be determined and compared for the following normal tissue toxicity parameters.

I. V 20 Both lungs (Combined total lung volumes including PTV): Volume of both lungs receiving ≥ 20 G y, including planning target volume.

II. Mean lung dose: Mean radiation dose received by both lungs in a given radiation plan, calculated by the planning computer.

III. V 55 Esophagus: Volume of esophagus receiving≥ 55Gy.

IV. Mean esophageal dose : Mean radiation dose received by whole esophagus in a given radiation plan, calculated by the planning computer

V. Spinal cord dose: Maximum dose received by the spinal cord in a given radiation plan.

V1.. V40 Whole heart: Volume of heart receiving ≥ 40Gy

2A Inter observer variation: This will be determined for the data sets GTV A and B only delineated by 4 radiation oncologists blinded to each other, for first 20 patients. The resident involved in this project will be responsible to co-ordinate this part of the project. GTV will be measured and recorded in cubic centimeters for each volume.

2B Intra observer variation: This will be determined for the data sets GTV A and B only delineated by the same radiation oncologist (treating physician) at two different occasions, for first 20 patients. Minimum time interval between the two contours will be one month .The resident involved in this project will be responsible to co-ordinate this part of the project. GTV will be measured and recorded in cubic centimeters for each volume.

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Manitoba
  - Winnipeg, Manitoba, Canada, R3E0V9
    - Cancer Care Manitoba

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pathologically proven NSCLC Clinical stage III A (inoperable) or stage IIIB where there is intent to pursue radical curative RT/chemo, staged with conventional imaging as outlined in standard work up section

Description

Inclusion Criteria:

Patients must be eligible for the Oncology FDG PET Winnipeg PET Program/Edmonton Cross Cancer Institute Extended Phase III Clinical Trial - Protocol 001, and in addition;
Pathologically proven NSCLC
Clinical stage III A (inoperable) or stage IIIB where there is intent to pursue radical curative RT/chemo, staged with conventional imaging as outlined in standard work up section.
ECOG Performance status 0-2
Age ≥ 18 years
FEV1 ≥ 1.0 L
No prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for one year or more for non primary bronchogenic cancers and two years for primary bronchogencic cancers;
No prior RT to thorax.
Must be able to start RT within 4 weeks after PET/CT simulation
Participants may be treated with radical radiation only or without concurrent chemotherapy, adjuvant chemotherapy or neo-adjuvant therapy.

Exclusion Criteria:

As per Oncology FDG PET Winnipeg PET Program/Edmonton Cross Cancer Institute Extended Phase III Clinical Trial - Protocol 001 and more specifically:
Unable/unwilling to give informed consent.
Uncontrolled hyperglycemia ( Blood sugar> 12 mmol/L)
Pregnant or lactating females

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Impact of PET/CT fusion on gross tumor volume for primary and nodal disease for each patient by comparing GTV contours using three separate data sets. Time Frame: From April 2007 -upto two years	From April 2007 -upto two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Investigators

Study Director: Naseer Ahmed, MD, CancerCare Manitoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

June 18, 2013

First Submitted That Met QC Criteria

June 25, 2013

First Posted (Estimate)

June 28, 2013

Study Record Updates

Last Update Posted (Estimate)