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

Lung Cancer Clinical Trial

Official title:

Comparative Study of Gross Tumor Volume Definition With or Without PET Fusion for Patients With Non-Small Cell Lung Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00310219
• Other study ID #: RTOG-0515
• Secondary ID: CDR0000465501
• Status: Completed
• Phase: N/A
• First received: March 29, 2006
• Last updated: January 23, 2014
• Start date: February 2006
• Est. completion date: November 2013

Study information

• Verified date: January 2014
• Source: Radiation Therapy Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: November 2013
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Procedure:
• computed tomography

• positron emission tomography

Locations

Country	Name	City	State
Canada	McGill Cancer Centre at McGill University	Montreal
United States	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Dallas	Texas
United States	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center	Madison	Wisconsin
United States	Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint Louis	St Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Radiation Therapy Oncology Group	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

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 (NSCL — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The impact of positron emission tomography (PET)/CT fusion planning on GTV (cm³) vs. planning with CT scan alone		Two treatment plans are centrally reviewed to determine the difference in gross tumor volume between the plans	No
Primary	The impact of positron emission tomography (PET)/CT fusion planning on number of contoured lymph nodes vs. planning with CT scan alone		Two treatment plans are centrally reviewed to determine the difference in number of contoured lymph nodes between the plans	No
Primary	The impact of positron emission tomography (PET)/CT fusion planning on location of involved lymph nodes vs planning with CT scan alone		Two treatment plans are centrally reviewed to determine the difference in location of involved lymph nodes between the plans	No
Primary	The impact of positron emission tomography (PET)/CT fusion planning on lung V20 vs planning with CT scan alone		Two treatment plans are centrally reviewed to determine the difference in lung V20 between the plans	No
Primary	The impact of positron emission tomography (PET)/CT fusion planning vs planning with CT scan alone on mean esophagus dose		Two treatment plans are centrally reviewed to determine the difference in mean esophagus dose between the plans	No
Secondary	Rate of elective nodal failures as assessed by failure in previously uninvolved regional lymph nodes at 2 years		From registration to 2 years	No