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Completed

NCT Number: 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

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.

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Key information

Conditions

Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McGill Cancer Centre at McGill University, Montreal, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computed Tomography

Procedure

Positron Emission Tomography

Procedure

Primary outcomes

  1. The impact of positron emission tomography (PET)/CT fusion planning on GTV (cm³) vs. planning with CT scan alone

    Time frame: Two treatment plans are centrally reviewed to determine the difference in gross tumor volume between the plans

  2. The impact of positron emission tomography (PET)/CT fusion planning on number of contoured lymph nodes vs. planning with CT scan alone

    Time frame: Two treatment plans are centrally reviewed to determine the difference in number of contoured lymph nodes between the plans

  3. The impact of positron emission tomography (PET)/CT fusion planning on location of involved lymph nodes vs planning with CT scan alone

    Time frame: Two treatment plans are centrally reviewed to determine the difference in location of involved lymph nodes between the plans

  4. The impact of positron emission tomography (PET)/CT fusion planning on lung V20 vs planning with CT scan alone

    Time frame: Two treatment plans are centrally reviewed to determine the difference in lung V20 between the plans

  5. The impact of positron emission tomography (PET)/CT fusion planning vs planning with CT scan alone on mean esophagus dose

    Time frame: 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

    Time frame: From registration to 2 years

Sponsors and collaborators

Lead sponsor

Radiation Therapy Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2010
Study completion
2013
First posted
Apr 3, 2006
Registry last updated
Jan 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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