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

Sponsors and Collaborators:	Radiation Therapy Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00310219

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

MedlinePlus related topics: CT Scans Cancer Lung Cancer Nuclear Scans

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic
Official Title:	Comparative Study of Gross Tumor Volume Definition With or Without PET Fusion for Patients With Non-Small Cell Lung Carcinoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Compare the impact of positron emission tomography (PET) or CT scan on contoured gross tumor volume vs CT scan alone by GTV (cm³) after completion of study treatment [ Designated as safety issue: No ]
Compare the impact of positron emission tomography (PET) or CT scan on contoured gross tumor volume vs CT scan alone by number of contoured lymph nodes after completion of study treatment [ Designated as safety issue: No ]
Compare the impact of positron emission tomography (PET) or CT scan on contoured gross tumor volume vs CT scan alone by location of involved lymph nodes after completion of study treatment [ Designated as safety issue: No ]
Compare the impact of positron emission tomography (PET) or CT scan on contoured gross tumor volume vs CT scan alone by V20 after completion of study treatment [ Designated as safety issue: No ]
Compare the impact of positron emission tomography (PET) or CT scan on contoured gross tumor volume vs CT scan alone by mean esophagus dose after completion of study treatment [ 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 [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	February 2006
Estimated Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

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

National Cancer Institute (NCI)

Investigators

Study Chair:	Jeffrey Bradley, MD	Mallinckrodt Institute of Radiology at Washington University Medical Center
Investigator:	Jacqueline Brunetti, MD	Sister Patricia Lynch Regional Cancer Center at Holy Name Hospital

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000465501, RTOG-0515
Study First Received:	March 29, 2006
Last Updated:	October 18, 2008
ClinicalTrials.gov Identifier:	NCT00310219
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

Carcinoma, Non-Small-Cell Lung
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 15, 2009