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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


N/A
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

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.

Outcome Time Frame:

From April 2007 -upto two years

Safety Issue:

No

Principal Investigator

Naseer Ahmed, MD

Investigator Role:

Study Director

Investigator Affiliation:

CancerCare Manitoba

Authority:

Canada: Bannatyne Campus Biomedical research ethics Board

Study ID:

B2006;089

NCT ID:

NCT01888692

Start Date:

April 2007

Completion Date:

December 2010

Related Keywords:

  • Lung Cancer
  • PET/CT
  • Radiotherapy
  • Lung Cancer
  • Lung Neoplasms

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