Phase II Trial of Standard Chemotherapy (Carboplatin & Paclitaxel) +Various Proton Beam Therapy (PBT) Doses

Overview

  • Study type

    Interventional
  • Study phase

    II
  • 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: 16-008343
    • Rochester, Minnesota: 16-008343
    NCT ID: NCT03132532
    Sponsor Protocol Number: MC1623

About this study

This study is being done to study which dose of proton beam therapy (PBT) for unresectable stage 2/3 Non-Small Cell 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:

  • Histological confirmation of non-small cell lung cancer
  • Forced Expiratory volume in 1 second (FEV1)>1.0 L
  • Unresectable stage 2-3 Non-small cell lung cancer (based on CT/positron emission tomography (PET), MRI or CT of brain, and Physical exam). • Eligible if recurrence after surgery and now has the equivalent stage 2-3 NSCLC OR had sub totally resected stage 2-3 NSCLC.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1
  • Negative pregnancy test done ≤7 days prior to registration, for women of childbearing potential only.
  • The following laboratory values in specified ranges:
    • White blood cell count (WBC) ≥3.0 x 109/L,
    • Absolute neutrophil count (ANC) ≥1.5 x 109/L,
    • Hgb ≥9g/dl
    • Plts >100 x 109/L
    • Serum creatinine<1.5 times upper limit of normal (ULN)
    • Serum bilirubin <1.5 times upper limit of normal (ULN)
  • Provide informed written consent.
  • Willing to return to enrolling institution for follow-up for a minimum of 1 year.
  • Ability to undergo potentially curative chemotherapy plus radiotherapy

Exclusion Criteria:

  • Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
    • Pregnant women
    • Nursing women
    • Men or women of childbearing potential who are unwilling to employ adequate contraception
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
  • Weight loss of >10% in the past 6 months
  • Distant metastases (M1 disease)
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, lupus, Usual interstitial pneumonitis (UIP), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Receiving any investigational agent, that would be considered as a treatment for the primary neoplasm.
  • Other active malignancy ≤3 years prior to registration. EXCEPTIONS: treated non-melanotic skin cancer, carcinoma-in-situ of the cervix, treated Stage 1-2, Gleason 7 or less, prostate cancer with a stable or undetectable prostate specific antigen (PSA) level, treated stage 1 breast cancer which is controlled and for which the patient received no thoracic radiotherapy (RT).
  • History of myocardial infarction ≤6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.
  • Received chemotherapy for lung cancer within 6 months of registration.
  • Previous chest radiotherapy.

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.

Open 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-20338647

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