Study of Positron Emission Tomography and Computed Tomography in Guiding Radiation Therapy in Patients With Stage III Non-small Cell Lung Cancer

Not Recruiting

Trial ID: NCT01507428


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.

Official Title

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)

Stanford Investigator(s)

Maximilian Diehn, MD, PhD
Maximilian Diehn, MD, PhD

Jack, Lulu, and Sam Willson Professor and Professor of Radiation Oncology (Radiation Therapy)

Kavitha Ramchandran
Kavitha Ramchandran

Clinical Professor, Medicine - Oncology

Heather Wakelee
Heather Wakelee

Professor of Medicine (Oncology)


Professor of Radiation Oncology (Radiation Therapy)

Joel Neal, MD, PhD
Joel Neal, MD, PhD

Associate Professor of Medicine (Oncology)


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 (within 2 weeks prior to
   registration on study)

   - Platelets >= 100,000 cells/mm^3 (within 2 weeks prior to registration on study)

   - Hemoglobin (Hgb) >= 10.0 g/dL (note: the use of transfusion or other intervention to
   achieve Hgb >= 10.0 g/dL is acceptable) (within 2 weeks prior to registration on

   - 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

Exclusion Criteria:

   - Patients with any component of small cell lung carcinoma are excluded

   - Patients with evidence of a malignant pleural or pericardial effusion are excluded

   - Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free
   for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity,
   or cervix are all permissible)

   - Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a
   different cancer is allowable

   - Prior radiotherapy to the region of the study cancer that would result in overlap of
   radiation therapy fields

   - Severe, active co-morbidity, defined as follows:

      - Unstable angina and/or congestive heart failure requiring hospitalization within
      the last 6 months

      - Transmural myocardial infarction within the last 6 months

      - Acute bacterial or fungal infection requiring intravenous antibiotics at the time
      of registration

      - Chronic obstructive pulmonary disease exacerbation or other respiratory illness
      requiring hospitalization or precluding study therapy at the time of registration

      - Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects;
      note, however, that laboratory tests for liver function and coagulation
      parameters are not required for entry into this protocol

      - Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease
      Control (CDC) definition; note, however, that human immunodeficiency virus (HIV)
      testing is not required for entry into this protocol

   - Pregnancy or women of childbearing potential and men who are sexually active and not
   willing/able to use medically acceptable forms of contraception

   - Poorly controlled diabetes (defined as fasting glucose level > 200 mg/dL) despite
   attempts to improve glucose control by fasting duration and adjustment of medications;
   patients with diabetes will preferably be scheduled in the morning and instructions
   for fasting and use of medications will be provided in consultation with the patients'
   primary physicians

   - Patients with T4 disease with radiographic evidence of massive invasion of a large
   pulmonary artery and tumor causing significant narrowing and destruction of that
   artery are excluded


radiation: external beam radiation therapy

radiation: image-guided adaptive radiation therapy

drug: paclitaxel

drug: carboplatin

procedure: positron emission tomography

procedure: computed tomography

other: laboratory biomarker analysis

drug: 18F-Fluoromisonidazole

drug: Fludeoxyglucose F-18

Not Recruiting

Contact Information

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

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