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Positron Emission Tomography Scan and CT Scan in Planning Radiation Therapy for Patients With Stage II or Stage III Non-Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
computed tomography
positron emission tomography
Sponsored by
Radiation Therapy Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Cancer focused on measuring stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, recurrent non-small cell lung cancer

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) Stage IIA/IIB or stage IIIA/IIIB disease Planning to undergo radiotherapy Local or regional nodal recurrence after surgery allowed No malignant pleural effusion PATIENT CHARACTERISTICS: Zubrod performance status 0-2 Negative pregnancy test Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: See Disease Characteristics Concurrent neoadjuvant and/or concurrent chemotherapy allowed No concurrent intensity-modulated radiotherapy

Sites / Locations

  • Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint Louis
  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
  • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
  • McGill Cancer Centre at McGill University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Two radiation oncologists are randomly assigned to develop either a 3DCRT plan using CT only, or a 3DCRT plan using fused PET/CT

Outcomes

Primary Outcome Measures

The impact of positron emission tomography (PET)/CT fusion planning on GTV (cm³) vs. planning with CT scan alone
The impact of positron emission tomography (PET)/CT fusion planning on number of contoured lymph nodes vs. planning with CT scan alone
The impact of positron emission tomography (PET)/CT fusion planning on location of involved lymph nodes vs planning with CT scan alone
The impact of positron emission tomography (PET)/CT fusion planning on lung V20 vs planning with CT scan alone
The impact of positron emission tomography (PET)/CT fusion planning vs planning with CT scan alone on mean esophagus dose

Secondary Outcome Measures

Rate of elective nodal failures as assessed by failure in previously uninvolved regional lymph nodes at 2 years

Full Information

First Posted
March 29, 2006
Last Updated
January 23, 2014
Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00310219
Brief Title
Positron Emission Tomography Scan and CT Scan in Planning Radiation Therapy for Patients With Stage II or Stage III Non-Small Cell Lung Cancer
Official Title
Comparative Study of Gross Tumor Volume Definition With or Without PET Fusion for Patients With Non-Small Cell Lung Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Imaging procedures, such as positron emission tomography (PET) scan and CT scan, may help doctors plan radiation therapy for patients with non-small cell lung cancer. PURPOSE: This clinical trial is studying how well a combined PET scan and CT scan works compared to a CT scan alone in planning radiation therapy for patients with stage II or stage III non-small cell lung cancer.
Detailed Description
OBJECTIVES: Primary Determine the impact of positron emission tomography (PET)/CT fusion scan and CT scan alone, by comparing gross tumor volume (GTV) contours and three-dimensional conformal radiotherapy treatment plans using 2 separate data sets (PET/CT fusion scan and CT scan only), in patients with stage II or III non-small cell lung cancer who are planning to undergo radiotherapy. Determine the impact of PET on GTV (cm^3), number of involved nodes, location of involved nodes, and dosimetric measures of normal tissue toxicity (mean lung dose, V20, and mean esophageal dose). Secondary Determine the rate of elective nodal failures (nodal failures in regions that are not intentionally irradiated to definitive doses [i.e., ipsilateral hilum, mediastinum, or ipsilateral supraclavicular fossa]). OUTLINE: This is a multicenter study. Patients are stratified according to neoadjuvant chemotherapy (yes vs no). Patients undergo a combined positron emission tomography (PET)/CT scan. Patients also undergo a CT scan alone. A single three-dimensional conformal radiotherapy (3DCRT) plan is generated from the combined PET/CT scan results. A single 3DCRT plan using the planning target volume is derived from the CT scan only. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, recurrent non-small cell lung cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Two radiation oncologists are randomly assigned to develop either a 3DCRT plan using CT only, or a 3DCRT plan using fused PET/CT
Intervention Type
Procedure
Intervention Name(s)
computed tomography
Intervention Type
Procedure
Intervention Name(s)
positron emission tomography
Primary Outcome Measure Information:
Title
The impact of positron emission tomography (PET)/CT fusion planning on GTV (cm³) vs. planning with CT scan alone
Time Frame
Two treatment plans are centrally reviewed to determine the difference in gross tumor volume between the plans
Title
The impact of positron emission tomography (PET)/CT fusion planning on number of contoured lymph nodes vs. planning with CT scan alone
Time Frame
Two treatment plans are centrally reviewed to determine the difference in number of contoured lymph nodes between the plans
Title
The impact of positron emission tomography (PET)/CT fusion planning on location of involved lymph nodes vs planning with CT scan alone
Time Frame
Two treatment plans are centrally reviewed to determine the difference in location of involved lymph nodes between the plans
Title
The impact of positron emission tomography (PET)/CT fusion planning on lung V20 vs planning with CT scan alone
Time Frame
Two treatment plans are centrally reviewed to determine the difference in lung V20 between the plans
Title
The impact of positron emission tomography (PET)/CT fusion planning vs planning with CT scan alone on mean esophagus dose
Time Frame
Two treatment plans are centrally reviewed to determine the difference in mean esophagus dose between the plans
Secondary Outcome Measure Information:
Title
Rate of elective nodal failures as assessed by failure in previously uninvolved regional lymph nodes at 2 years
Time Frame
From registration to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) Stage IIA/IIB or stage IIIA/IIIB disease Planning to undergo radiotherapy Local or regional nodal recurrence after surgery allowed No malignant pleural effusion PATIENT CHARACTERISTICS: Zubrod performance status 0-2 Negative pregnancy test Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: See Disease Characteristics Concurrent neoadjuvant and/or concurrent chemotherapy allowed No concurrent intensity-modulated radiotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Bradley, MD
Organizational Affiliation
Mallinckrodt Institute of Radiology at Washington University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jacqueline Brunetti, MD
Organizational Affiliation
Sister Patricia Lynch Regional Cancer Center at Holy Name Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint Louis
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-6164
Country
United States
Facility Name
McGill Cancer Centre at McGill University
City
Montreal
ZIP/Postal Code
H2W 1S6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
21075551
Citation
Bradley J, Bae K, Choi N, Forster K, Siegel BA, Brunetti J, Purdy J, Faria S, Vu T, Thorstad W, Choy H. A phase II comparative study of gross tumor volume definition with or without PET/CT fusion in dosimetric planning for non-small-cell lung cancer (NSCLC): primary analysis of Radiation Therapy Oncology Group (RTOG) 0515. Int J Radiat Oncol Biol Phys. 2012 Jan 1;82(1):435-41.e1. doi: 10.1016/j.ijrobp.2010.09.033. Epub 2010 Nov 13.
Results Reference
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Positron Emission Tomography Scan and CT Scan in Planning Radiation Therapy for Patients With Stage II or Stage III Non-Small Cell Lung Cancer

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