Proton therapy breakthrough: fewer radiation sessions could boost lung cancer survival
NCT ID NCT01770418
First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study tests a new way to deliver proton radiation for stage II-III non-small cell lung cancer. Instead of standard daily doses over many weeks, patients receive higher doses per session (hypofractionation) over a shorter time, combined with chemotherapy. The goal is to find the safest highest dose and see if it helps patients live at least 12 months. About 32 people are taking part.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Proton radiotherapy with chemotherapy (paclitaxel/carboplatin or cisplatin/etoposide)
- What this could lead to
- If successful, this could lead to a shorter, more effective radiation schedule for lung cancer, potentially improving survival and reducing side effects.
- What could go wrong
- This is an early-phase trial with only 32 participants, so results may not apply to all patients. Higher radiation doses also carry increased risk of lung or heart damage.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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32 people
The number who actually took part.
- Start date
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Mar 2013
- 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: * Pathologically confirmed invasive non-small cell lung cancer within 12 weeks prior to study registration. OR Pathologically confirmed invasive non-small cell lung cancer within 6 months prior to study registration if the patient received induction chemotherapy. * AJCC (American Joint Committee on Cancer) 7th Ed. clinical stage II-III. * ECOG Performance status 0-1 within 8 weeks prior to study registration. * Patient must give study-specific informed consent on an IRB-approved consent prior to any research-related procedures or study treatment. * Patient must be at least 18 years old at the time of consent. * Patient must complete all required tests in section 4. * Lab results per the following within 4 weeks prior to study registration: * Absolute neutrophil count (ANC) \>1,800 cells/mm3. * Platelets \> = 100,000 cells/mm3. * Hemoglobin \> =10 g/dl. The use of transfusion or other intervention to achieve Hgb ≥10.0 g/dl is acceptable. * AST/SGOT and ALT/SGPT \< 2.5 x the institutional upper limit of normal (IULN). * Post exploratory thoracotomy must be done \> 3 weeks prior to study registration or patient did not have post exploratory thoracotomy. * PFT (pulmonary function test) with a FEV1 \> 0.75 liters/second within 16 weeks prior to study registration. * Patients must be evaluated by a thoracic surgeon, pulmonologist or medical oncologist and deemed medically or surgically unacceptable for resection. Exclusion Criteria: * Evidence of distant metastasis (M1) involvement. * Prior radiotherapy to thoracic area. * Unintentional weight loss \>10% within 4 weeks prior to study registration. * Pregnant and/or breast-feeding women, or patients (men and women) of child-producing potential not willing to use medically acceptable forms of contraception while on study treatment and for at least 12 months after study treatment. Pregnancy testing is not necessary for women who have had a hysterectomy or have not had a menstrual period for at least 24 consecutive months.
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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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Hampton University Proton Therapy Institute
Hampton, Virginia, 23666, United States
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Maryland Proton Treatment Center
Baltimore, Maryland, 21201, United States
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Northwestern Medicine Chicago Proton Center
Warrenville, Illinois, 60555, United States
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Oklahoma Proton Center
Oklahoma City, Oklahoma, 73142, United States
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Princeton ProCure Management LLC
Somerset, New Jersey, 08873, United States
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University of Florida Proton Therapy Institute
Jacksonville, Florida, 32206, United States
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