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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00310219
First received: March 29, 2006
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Lung Cancer
Procedure: computed tomography
Procedure: positron emission tomography

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Comparative Study of Gross Tumor Volume Definition With or Without PET Fusion for Patients With Non-Small Cell Lung Carcinoma

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: February 2006
Study Completion Date: November 2013
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Two radiation oncologists are randomly assigned to develop either a 3DCRT plan using CT only, or a 3DCRT plan using fused PET/CT
Procedure: computed tomography Procedure: positron emission tomography

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00310219

Locations
United States, Missouri
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint Louis
St Louis, Missouri, United States, 63110
United States, Texas
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
United States, Wisconsin
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Canada
McGill Cancer Centre at McGill University
Montreal, Canada, H2W 1S6
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Principal Investigator: Jeffrey Bradley, MD Mallinckrodt Institute of Radiology at Washington University Medical Center
Study Chair: Jacqueline Brunetti, MD Sister Patricia Lynch Regional Cancer Center at Holy Name Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00310219     History of Changes
Other Study ID Numbers: RTOG-0515, CDR0000465501
Study First Received: March 29, 2006
Last Updated: January 23, 2014
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 15, 2014