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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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014