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


N/A
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Diagnostic

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

Jeffrey Bradley, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mallinckrodt Institute of Radiology at Washington University Medical Center

Authority:

United States: Federal Government

Study ID:

CDR0000465501

NCT ID:

NCT00310219

Start Date:

February 2006

Completion Date:

Related Keywords:

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

Name

Location

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Madison, Wisconsin  53792-6164
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas, Texas  75390
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint Louis St Louis, Missouri  63110