Active Not RecruitingPhase 1 / Phase 2NCT01770418

A Phase I/II Study of Hypofractionated Proton Therapy for Stage II-III Non-Small Cell Lung Cancer

The purpose of this research study is to compare the effects (good and bad) on subjects and their cancer using standard chemotherapy in combination with hypofractionated proton radiation therapy. Hypofractionation is a technique that delivers higher daily doses of radiation over a shorter period of time.

Checked against the public recordLast updated Sep 9, 2025 · Source: ClinicalTrials.gov

StatusActive Not Recruiting
PhasePhase 1 / Phase 2
U.S. locations6
SponsorProton Collaborative Group
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Proton Collaborative Group
Interventions being studied
Radiation: Radiation with Concurrent Chemotherapy
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of Florida Proton Therapy InstituteJacksonville, Florida
  • Northwestern Medicine Chicago Proton CenterWarrenville, Illinois
  • Maryland Proton Treatment CenterBaltimore, Maryland
  • Princeton ProCure Management LLCSomerset, New Jersey
  • Oklahoma Proton CenterOklahoma City, Oklahoma
  • Hampton University Proton Therapy InstituteHampton, Virginia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 9, 2025. Always confirm current availability with the study team.

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