Clinical trial NCT00310219: Positron Emission Tomography Scan and CT Scan in Planning Radiation Therapy for Patients With Stage II or Stage III Non-Small Cell Lung Cancer
Official title: Comparative Study of Gross Tumor Volume Definition With or Without PET Fusion for Patients With Non-Small Cell Lung Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Radiation Therapy Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-04-03
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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 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

Primary outcomes:
measure: The impact of positron emission tomography (PET)/CT fusion planning on GTV (cm³) vs. planning with CT scan alone
timeFrame: Two treatment plans are centrally reviewed to determine the difference in gross tumor volume between the plans
measure: The impact of positron emission tomography (PET)/CT fusion planning on number of contoured lymph nodes vs. planning with CT scan alone
timeFrame: Two treatment plans are centrally reviewed to determine the difference in number of contoured lymph nodes between the plans
measure: The impact of positron emission tomography (PET)/CT fusion planning on location of involved lymph nodes vs planning with CT scan alone
timeFrame: Two treatment plans are centrally reviewed to determine the difference in location of involved lymph nodes between the plans
measure: The impact of positron emission tomography (PET)/CT fusion planning on lung V20 vs planning with CT scan alone
timeFrame: Two treatment plans are centrally reviewed to determine the difference in lung V20 between the plans
measure: The impact of positron emission tomography (PET)/CT fusion planning vs planning with CT scan alone on mean esophagus dose
timeFrame: Two treatment plans are centrally reviewed to determine the difference in mean esophagus dose between the plans
Secondary outcomes:
measure: Rate of elective nodal failures as assessed by failure in previously uninvolved regional lymph nodes at 2 years
timeFrame: From registration to 2 years
Other outcomes:
Locations:
city: St Louis
country: United States
facility: Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint Louis
state: Missouri
city: Dallas
country: United States
facility: Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
state: Texas
city: Madison
country: United States
facility: University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
state: Wisconsin
city: Montreal
country: Canada
facility: McGill Cancer Centre at McGill University
Study officials:
affiliation: Mallinckrodt Institute of Radiology at Washington University Medical Center
name: Jeffrey Bradley, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sister Patricia Lynch Regional Cancer Center at Holy Name Hospital
name: Jacqueline Brunetti, MD
role: STUDY_CHAIR
References:
citation: 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.