Proton vs. photon: which radiation beats lung cancer best?
NCT ID NCT01993810
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two types of radiation therapy (proton and photon) combined with chemotherapy for people with stage II-IIIB non-small cell lung cancer that cannot be surgically removed. The goal is to see which approach helps patients live longer and causes fewer side effects. About 330 adults are participating in this phase 3 trial.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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330 people
The number who actually took part.
- Started
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Jan 2014
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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: * Histologically or cytologically proven diagnosis of non-small cell lung cancer * Clinical American Joint Committee on Cancer (AJCC) (AJCC, 7th ed.) II, IIIA or IIIB (with non-operable disease; non-operable disease will be determined by a multi-disciplinary treatment team within 60 days prior to registration; note: for patients who are clearly nonresectable, the case can be determined by the treating radiation oncologist and/or a medical oncologist or pulmonologist * Patients who present with N2 or N3 disease and an undetectable NSCLC primary tumor are eligible * Patients who refuse surgery are eligible * Patients who develop local recurrence after surgery and rendered candidate for definitive concurrent chemoradiation are also eligible * Patients who have received systemic treatment (up to 4 cycles of induction chemotherapy, or up to 6 months of targeted therapy) are eligible * Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup: * History/physical examination within 30 days prior to registration including resting heart rate; * Fludeoxyglucose F 18 (FDG)-positron emission tomography (PET)/computed tomography (CT) scan for staging within 60 days prior to registration * Magnetic resonance imaging (MRI) scan with contrast of the brain (preferred) or CT scan of the brain with contrast within 60 days prior to registration; * Forced expiratory volume in one second (FEV1) \>= 0.8 liter or \>= 35% predicted with or without bronchodilator within 90 days prior to registration; * Patients who meet the criterion above without oxygen (O2), but who need acute (started within 10 days prior to registration) supplemental oxygen due to tumor-caused obstruction/hypoxia are eligible, provided the amount of the O2 needed has been stable * Zubrod performance status 0-1 within 30 days prior to registration * Absolute neutrophil count (ANC) \>= 1,500 cells/mm\^3 obtained within 30 days prior to registration * Platelets \>= 100,000 cells/mm\^3 obtained within 30 days prior to registration * Hemoglobin \>= 9.0 g/dl (note: the use of transfusion or other intervention to achieve hemoglobin \[Hgb\] \>= 9.0 g/dl is acceptable), obtained within 30 days prior to registration * Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) within 30 days prior to registration * It is highly recommended but not required that SGOT or SGPT be =\< 1.5 upper limit of normal * Total bilirubin =\< 1.5 within 30 days prior to registration * It is highly recommended but not required that total bilirubin be =\< 1.5 upper limit of normal * Serum creatinine \< 1.5 mg/dL or calculated creatinine clearance \>= 50 mL/min within 30 days prior to registration estimated by the Cockcroft-Gault formula * Peripheral neuropathy =\< grade 1 at the time of registration * Patients with non-malignant pleural effusion are eligible * If a pleural effusion is present, the following criteria must be met to exclude malignant involvement: * When pleural fluid is visible on both the 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 * Effusions that are minimal (i.e, not visible on chest x-ray) that are too small to safely tap are eligible * Patients must have measurable or evaluable disease * Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to registration * Women of childbearing potential and male participants must practice adequate contraception * Patient must provide study-specific informed consent prior to study entry Exclusion Criteria: * Prior invasive malignancy unless disease free for a minimum of 3 years; however, skin cancer and in situ carcinomas of the breast, oral cavity, cervix, and other organs and are permissible * Patients with prior history of either small cell lung cancer or NSCLC regardless of the treatment received, other than patients who have recurrent disease following resection * Prior systemic chemotherapy for the study cancer, if more than 4 cycles of induction chemotherapy or more than 6 months of targeted therapy; note that prior chemotherapy for a different cancer is allowable * Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields * Severe, active co-morbidity, defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months; * Transmural myocardial infarction within the last 6 months; * Chronic obstructive pulmonary disease exacerbation or other respiratory illness other than the diagnosed lung cancer requiring hospitalization or precluding study therapy within 30 days before registration; * Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol * Unintentional weight loss \> 10% within 30 days prior to registration * Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
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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
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Central Maryland Radiation Oncology in Howard County
Columbia, Maryland, 21044, United States
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M D Anderson Cancer Center
Houston, Texas, 77030, United States
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MD Anderson Regional Care Center-Bay Area
Nassau Bay, Texas, 77058, United States
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MD Anderson Regional Care Center-Katy
Houston, Texas, 77094, United States
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MD Anderson Regional Care Center-Sugar Land
Sugar Land, Texas, 77478, United States
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MD Anderson Regional Care Center-The Woodlands
The Woodlands, Texas, 77384, United States
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Maryland Proton Treatment Center
Baltimore, Maryland, 21201, United States
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Mass General/North Shore Cancer Center
Danvers, Massachusetts, 01923, United States
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Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
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Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
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Memorial Sloan Kettering Rockville Centre
Rockville Centre, New York, 11570, United States
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Memorial Sloan Kettering Sleepy Hollow
Sleepy Hollow, New York, 10591, United States
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Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
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Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555, United States
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ProCure Proton Therapy Center-Seattle
Seattle, Washington, 98133, United States
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ProCure Proton Therapy Center-Somerset
Somerset, New Jersey, 08873, United States
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Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141, United States
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Tate Cancer Center
Glen Burnie, Maryland, 21061, United States
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Tennessee Cancer Specialists-Dowell Springs
Knoxville, Tennessee, 37909, United States
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Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
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University of Cincinnati Medical Center
Cincinnati, Ohio, 45267, United States
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University of Florida Health Science Center - Jacksonville
Jacksonville, Florida, 32209, United States
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University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
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University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
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University of Washington Medical Center
Seattle, Washington, 98195, United States
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Upper Chesapeake Medical Center
Bel Air, Maryland, 21014, United States
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Washington University School of Medicine
St Louis, Missouri, 63110, United States
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West Chester Hospital
West Chester, Ohio, 45069, United States
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