Status:

UNKNOWN

Fludeoxyglucose F18 Positron Emission Tomography Imaging In Assessing Patients Before and After Treatment for Locally Advanced Non-Small Cell Lung Cancer

Lead Sponsor:

American College of Radiology Imaging Network

Collaborating Sponsors:

National Cancer Institute (NCI)

Radiation Therapy Oncology Group

Conditions:

Lung Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

RATIONALE: Imaging procedures, such as fludeoxyglucose F18 positron emission tomography (\^18FDG-PET), may improve the ability to detect disease progression and help doctors predict a patient's respon...

Detailed Description

OBJECTIVES: Primary * Determine whether peak standardized uptake value (SUV) for fludeoxyglucose F 18 positron emission tomography (FDG-PET) shortly after definitive chemoradiotherapy is predictive ...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed non-small cell lung cancer (NSCLC)
  • Clinical stage IIB or III disease
  • No small cell carcinoma
  • No stage IV disease\*
  • No diffuse bronchoalveolar subtype
  • No planned definitive surgical resection NOTE: \*Patients with evidence of stage IV disease by positron emission tomography are eligible if the evidence cannot be confirmed by other means AND the physician still plans to proceed with definitive chemoradiation
  • Planning treatment with definitive chemoradiotherapy
  • May be treated on another Radiation Therapy Oncology Group protocol (except phase I studies) OR with conventional concurrent NSCLC chemoradiotherapy
  • Radiotherapy ≥ 60 Gy AND chemotherapy to include concurrent platinum-based therapy
  • No brain metastases by head CT scan or MRI
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • Zubrod 0-1
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Not specified
  • Hepatic
  • Not specified
  • Renal
  • Not specified
  • Other
  • Medically suitable for early concurrent chemoradiotherapy (radiotherapy dose ≥ 60 Gy)
  • Able to tolerate positron emission tomography imaging
  • No poorly controlled diabetes (defined as fasting glucose level \> 200 mg/dL)
  • No other malignancy within the past 3 years except basal cell or squamous cell skin cancer or carcinoma in situ
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • No anticipated use of adjuvant biologic therapy beyond 14 weeks after the completion of radiotherapy
  • Chemotherapy
  • See Disease Characteristics
  • No anticipated use of adjuvant chemotherapy beyond 14 weeks after the completion of radiotherapy
  • Endocrine therapy
  • Not specified
  • Radiotherapy
  • See Disease Characteristics
  • No prior thoracic radiotherapy
  • No concurrent intensity-modulated radiotherapy
  • Surgery
  • See Disease Characteristics

Exclusion

    Key Trial Info

    Start Date :

    March 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    250 Patients enrolled

    Trial Details

    Trial ID

    NCT00083083

    Start Date

    March 1 2005

    Last Update

    March 1 2011

    Active Locations (49)

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    Page 1 of 13 (49 locations)

    1

    Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham

    Birmingham, Alabama, United States, 35294

    2

    Scottsdale Medical Imaging, Limited

    Scottsdale, Arizona, United States, 85262

    3

    USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, United States, 90089-9181

    4

    Radiological Associates of Sacramento Medical Group at Sutter Cancer Center

    Sacramento, California, United States, 95816