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

NCT00310219 | Completed DMC

• 2 other identifiers: RTOG-0515CDR0000465501
• Study Type: interventional
• Target: 52
• Locations: 2 countries
• Sites: 4

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Secondary Outcomes (1)

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

  From registration to 2 years

Study Arms (1)

Arm 1

EXPERIMENTAL

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

Interventions

computed tomography PROCEDURE

Arm 1

positron emission tomography PROCEDURE

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Radiation Therapy Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint Louis

St Louis, Missouri, 63110, United States

Location

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390, United States

Location

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Madison, Wisconsin, 53792-6164, United States

Location

McGill Cancer Centre at McGill University

Montreal, H2W 1S6, Canada

Location

Related 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 (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.

  PMID: 21075551 RESULT

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Jeffrey Bradley, MD

  Mallinckrodt Institute of Radiology at Washington University Medical Center

  PRINCIPAL INVESTIGATOR

• Jacqueline Brunetti, MD

  Sister Patricia Lynch Regional Cancer Center at Holy Name Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2006
• First Posted: April 3, 2006
• Study Start: February 1, 2006
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2013
• Last Updated: January 24, 2014

Record last verified: 2014-01

Locations

CA (1); US (3)