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RTOG 1106   |   081201C
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)

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  1. RTOG: To determine whether tumor dose can be escalated to improve the LRPF rate at 2 years when an individualized adaptive radiation treatment (RT) plan is applied by the use of a FDG-PET/CT scan acquired at 40-46 Gy initial dose of RT in patients with inoperable or unresectable stage III NSCLC;
  2. ACRIN: To determine whether the relative change in SUVpeak from the baseline to the during-treatment FDG-PET/CT, defined as (during-treatment SUVpeak - baseline SUVpeak)/baseline SUVpeak x 100%, can predict the LRPF with a 2-year follow up.

Inclusion Criteria
  1. 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.
  2. Patients must be clinical 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.
  3. Patients with multiple, ipsilateral pulmonary nodules (T3, or T4) are eligible if a definitive course of daily fractionated RT is planned.
  4. Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup:
    1. History/physical examination, including documentation of weight, within 2 weeks prior to registration;
    2. FDG-PET/CT scan for staging and RT plan within 4 weeks prior to registration;
    3. CT scan of chest and upper abdomen with IV contrast within 6 weeks prior to registration;
    4. CT scan of the brain with contrast or MRI of the brain within 6 weeks prior to registration;
    5. Pulmonary function tests, including DLCO, within 6 weeks prior to registration; patients must have FEV1 ≥ 1.2 Liter or ≥ 50% predicted without bronchodilator;
    6. Zubrod Performance Status 0-1 within 2 weeks prior to registration;
    7. Age ≥ 18;
    8. Able to tolerate PET/CT imaging required to be performed at an ACRIN qualified facility;
    9. CBC/differential obtained within 2 weeks prior to registration on study, with adequate bone marrow function defined as follows:
    10. Absolute neutrophil count (ANC) ≥ 1,500 cells/mm^3;
    11. Platelets ≥ 100,000 cells/mm^3;
    12. Hemoglobin ≥ 10.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 10.0 g/dl is acceptable.);
  5. Serum creatinine within normal institutional limits or a creatinine clearance ≥ 60 ml/min within 2 weeks prior to registration;
  6. Negative serum or urine pregnancy test within 3 days prior to registration for women of childbearing potential;
  7. 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.
  8. The patient must provide study-specific informed consent prior to study entry.

Exclusion Criteria
  1. Patients with any component of small cell lung carcinoma are excluded.
  2. Patients with evidence of a malignant pleural or pericardial effusion are excluded.
  3. 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);
  4. Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable.
  5. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
  6. Severe, active co-morbidity, defined as follows:
    1. Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;
    2. Transmural myocardial infarction within the last 6 months;
    3. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
    4. Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration;
    5. 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.
    6. Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.
  7. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
  8. 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;
  9. For FMISO-PET/CT: patient is unable to undergo this imaging;
  10. Patients with T4 disease with radiographic evidence of massage invasion of a large pulmonary artery and tumor causing significant narrowing and destruction of that artery are excluded.

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