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NCT03132532CompletedPhase 2

Platinum Doublet Chemotherapy and Proton Beam Radiation Therapy in Treating Patients With Stage II-III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery

Phase II Trial of Standard Platinum Doublet Chemotherapy + Various Proton Beam Therapy (PBT) Doses in Order to Determine the Optimal Dose of PBT for Unresectable Stage 2/3 Non-Small Cell Lung Cancer

Source: ClinicalTrials.gov · Last updated 25 Nov 2025

Brief summary (registry, in English)

This randomized phase II trial studies how well platinum doublet chemotherapy and proton beam radiation therapy work in treating patients with stage II-III non-small cell lung cancer that cannot be removed by surgery (unresectable). Drugs used in chemotherapy, such as carboplatin, paclitaxel, etoposide, cisplatin, and pemetrexed work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy protons to kill tumor cells and shrink tumors. Giving platinum doublet chemotherapy and proton beam radiation therapy may work better in treating patients with non-small cell lung cancer.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
20 (actual)
First submitted
25 Apr 2017
Start date
31 Jul 2017
Primary completion date
23 Dec 2023
Lead sponsor
Mayo Clinic
Diseases
Lung cancer
NCT number
NCT03132532

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 20
  • From 31 Jul 2017 to the primary completion date, 23 Dec 2023
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • Receiving any investigational agent, that would be considered as a treatment for the primary neoplasm
  • Received chemotherapy for lung cancer within 6 months of registration
  • Previous chest radiotherapy that would overlap with the proton field

Other illness

  • 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
  • Active second malignancy
  • History of myocardial infarction =\< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias

Other

  • 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
  • Weight loss of \> 10% in the past 3 months

Who the study is looking for

  • Age \>= 18 years
  • Histological confirmation of non-small cell lung cancer
  • Forced expiratory volume in 1 second (FEV1) \> 1.0 L
  • Unresectable or medically inoperable stage 2-3 non-small cell lung cancer (based on computed tomography/positron emission tomography \[CT/PET\], magnetic resonance imaging \[MRI\] or CT of brain, and physical exam);
    • Eligible if recurrence after surgery and now has the equivalent stage 2-3 non-small cell lung cancer (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
  • White blood cell (WBC) \>= 3.0 x 10\^9/L
  • Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L
  • Hemoglobin (Hgb) \>= 9 g/dl
  • Platelets (plts) \> 100 x 10\^9/L
  • Serum creatinine \< 1.5 x upper limits of normal (ULN)
  • Serum bilirubin \< 1.5 x 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Mayo Clinic in Rochester
Coordinator of this site? Confirm its status
RochesterUnited StatesUnknown status
Mayo Clinic in Arizona
Coordinator of this site? Confirm its status
ScottsdaleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.