Randomized Phase II Trial of Individualized Adaptive Radiotherapy Using During-Treatment FDG-PET/CT and Modern Technology in Locally Advanced Non-small Cell Lung Cancer (NSCLC)

This randomized phase II trial studies how well positron emission tomography (PET)/computed tomography (CT)-guided radiation therapy works compared to standard radiation therapy in treating patients with stage III non-small cell lung cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Using imaging procedures, such as PET and CT scans, to guide the radiation therapy, may help doctors deliver higher doses directly to the tumor and cause less damage to healthy tissue.

Stanford is now accepting new patients for this trial. Please contact Laura Gable at 6507360798 for more information.

Investigator(s):

Intervention(s):

  • drug : carboplatin
  • drug : paclitaxel
  • other : laboratory biomarker analysis
  • procedure : positron emission tomography
  • procedure : computed tomography
  • radiation : Fludeoxyglucose F-18
  • radiation : image-guided adaptive radiation therapy
  • radiation : external beam radiation therapy

Phase: Phase 2

Eligibility

Ages Eligible For Study:

18 Years - N/A

Inclusion Criteria

- Patients must have FDG-avid (maximum SUV >= 4.0) (from PET scan of any date, any scanner) and histologically or cytologically proven non-small cell lung cancer - Patients must be clinical American Joint Committee on Cancer (AJCC) stage IIIA or IIIB (AJCC, 7th ed.) with non-operable disease; non-operable disease will be determined by a multi-disciplinary treatment team, involving evaluation by at least 1 thoracic surgeon within 8 weeks prior to registration; Note: For patients who are clearly nonresectable, the case can be determined by the treating radiation oncologist and a medical oncologist, or pulmonologist - Patients with multiple, ipsilateral pulmonary nodules (T3 or T4) are eligible if a definitive course of daily fractionated radiation therapy (RT) is planned - History/physical examination, including documentation of weight, within 2 weeks prior to registration - FDG-PET/CT scan for staging and RT plan within 4 weeks prior to registration - CT scan or sim CT of chest and upper abdomen (IV contrast is recommended unless medically contraindicated) within 6 weeks prior to registration - CT scan of the brain (contrast is recommended unless medically contraindicated) or MRI of the brain within 6 weeks prior to registration - Pulmonary function tests, including diffusion capacity of carbon monoxide (DLCO), within 6 weeks prior to registration; patients must have forced expiratory volume in 1 second (FEV1) >= 1.2 Liter or >= 50% predicted without bronchodilator - Zubrod performance status 0-1 - Able to tolerate PET/CT imaging required to be performed at an American College of Radiology (ACR) Imaging Core Laboratory (Lab) qualified facility - Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 - Platelets >= 100,000 cells/mm^3 - Hemoglobin (Hgb) >= 10.0 g/dL (note: the use of transfusion or other intervention to achieve Hgb >= 10.0 g/dL is acceptable) - Serum creatinine within normal institutional limits or a creatinine clearance >= 60 ml/min within 2 weeks prior to registration - Negative serum or urine pregnancy test within 3 days prior to registration for women of childbearing potential - Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study - The patient must provide study-specific informed consent prior to study entry

External Links

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Contact information

Primary Contact:

Laura Gable 6507360798

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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