Proton beam doses put to the test for tough lung cancers
NCT ID NCT03132532
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This trial tested different doses of proton beam therapy combined with standard chemotherapy for people with stage 2-3 non-small cell lung cancer that cannot be surgically removed. The goal was to find the best radiation dose to control the cancer. Twenty participants received treatment, and researchers tracked how long the cancer stayed under control and overall survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- proton beam therapy and platinum doublet chemotherapy (carboplatin, cisplatin, paclitaxel, etoposide, pemetrexed)
- What this could lead to
- If successful, this could help determine the best proton beam dose to improve outcomes for people with inoperable lung cancer.
- What could go wrong
- This is a small, early-phase trial with only 20 participants, so results may not apply to everyone. The optimal dose may not clearly improve survival.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
20 people
The number who actually took part.
- Started
-
Jul 2017
- Finished
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Dec 2023
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 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 3 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 * Active second malignancy * 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 that would overlap with the proton field
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
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Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
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