Specialized Radiation Therapy and Chemotherapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

Overview

  • Study type

    Interventional
  • Study phase

    I
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Scottsdale/Phoenix, Arizona: 12-006280
    • Rochester, Minnesota: 12-006280
    NCT ID: NCT01486602
    Sponsor Protocol Number: CALGB 31102

About this study

The purpose of this study is to test the safety of radiation therapy given at increased doses in a shorter period of time in order to find out what effects, good and/or bad, it has on the patient and the lung cancer. The standard way of giving the radiation therapy is to give it once daily for 6 to 7 weeks. The study is currently testing if a higher amount of radiation therapy per treatment can be given as well as shorten the total number of treatments to 4 or 5 weeks. The goal is that a higher dose of radiation therapy per treatment will be more effective than current standard treatments. In addition to the radiation treatment, patients will receive chemotherapy with carboplatin and paclitaxel, which are standard drugs for treating lung cancer.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  1. Documentation of Disease (American Joint Committee on Cancer Version 7)
    • Histologically or cytologically documented non-small cell lung cancer (NSCLC)
    • Stage: IIIA or IIIB NSCLC. Patients who present with N2 or N3 disease and an undetectable primary tumor are also eligible.
    • Tumor Site: Thoracic disease without supraclavicular or contralateral hilar involvement
    • Pleural Effusion: When pleural fluid is visible on both CT scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative.

    Exudative pleural effusions are excluded regardless of cytology. Patients with effusions that are minimal (i.e. not visible on chest x-ray) too small to safely tap are eligible.

  2. Prior Treatment
    • No prior radiotherapy or chemotherapy for NSCLC
    • No prior mediastinal or thoracic radiotherapy
    • Patients with complete surgical resection of disease are not eligible, however, patients with surgical resection and measurable gross residual disease present on imaging are considered eligible.
  3. Patients must have Measurable Disease
    • Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 2 cm with conventional techniques or as ≥ 1 cm with spiral CT scan.
    • Patients with non-measurable disease are not eligible
    • All other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan) and truly non-measurable lesions.
    • Lesions that are considered non-measurable include the following:
      • Bone lesions
      • Leptomeningeal disease
      • Ascites
      • Pleural/pericardial effusion
      • Inflammatory breast disease
      • Lymphangitis cutis/pulmonis
      • Abdominal masses that are not confirmed and followed by imaging techniques
      • Cystic lesions
  4. Age ≥ 18 years
  5. ECOG Performance Status 0-1
  6. No patients that are known to be pregnant or nursing.
  7. Required Initial Laboratory Values:
    • Granulocytes ≥ 1,500/μl
    • Platelet count ≥ 100,000/μl
    • Bilirubin ≤ 1.5 x ULN
    • AST (SGOT) ≤ 2.0 x ULN
    • Serum Creatinine ≤ 1.5 x ULN or
    • Calculated Creatinine Clearance ≥ 70 ml/min
    • FEV-1 ≥ 1.2 liters/second or 50% predicted

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Steven Schild, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Steven Schild, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

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CLS-20112247

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