NCT01993810Active, not recruitingPhase 3
Comparing Photon Therapy To Proton Therapy To Treat Patients With Lung Cancer
Phase III Randomized Trial Comparing Overall Survival After Photon Versus Proton Chemoradiotherapy for Inoperable Stage II-IIIB NSCLC
Source: ClinicalTrials.gov · Last updated 8 Jun 2026
Brief summary (registry, in English)
This randomized phase III trial studies proton chemoradiotherapy to see how well it works compared to photon chemoradiotherapy in treating patients with stage II-IIIB non-small cell lung cancer that cannot be removed by surgery. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor, such as photon or proton beam radiation therapy, may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as paclitaxel, carboplatin, etoposide, and cisplatin, 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. It is not yet known whether proton chemoradiotherapy is more effective than photon chemoradiotherapy in treating non-small cell lung cancer.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 330 (actual)
- First submitted
- 12 Nov 2013
- Start date
- 3 Jan 2014
- Primary completion date
- 30 Nov 2028
- Lead sponsor
- Radiation Therapy Oncology Group
- Diseases
- Lung cancer
- NCT number
- NCT01993810
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 330
- From 3 Jan 2014 to the primary completion date, 30 Nov 2028
- 30 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
- 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
Other illness
- 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
Other
- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (30)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Maryland/Greenebaum Cancer Center Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Maryland Proton Treatment Center Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Memorial Sloan Kettering Basking Ridge Coordinator of this site? Confirm its status | Basking Ridge | United States | Unknown status |
| Upper Chesapeake Medical Center Coordinator of this site? Confirm its status | Bel Air | United States | Unknown status |
| Massachusetts General Hospital Cancer Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University of Cincinnati Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Central Maryland Radiation Oncology in Howard County Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
| Memorial Sloan Kettering Commack Coordinator of this site? Confirm its status | Commack | United States | Unknown status |
| Siteman Cancer Center at West County Hospital Coordinator of this site? Confirm its status | Creve Coeur | United States | Unknown status |
| Mass General/North Shore Cancer Center Coordinator of this site? Confirm its status | Danvers | United States | Unknown status |
| Tate Cancer Center Coordinator of this site? Confirm its status | Glen Burnie | United States | Unknown status |
| Memorial Sloan Kettering Westchester Coordinator of this site? Confirm its status | Harrison | United States | Unknown status |
| MD Anderson Regional Care Center-Katy Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| M D Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| University of Florida Health Science Center - Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Tennessee Cancer Specialists-Dowell Springs Coordinator of this site? Confirm its status | Knoxville | United States | Unknown status |
| MD Anderson Regional Care Center-Bay Area Coordinator of this site? Confirm its status | Nassau Bay | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University of Pennsylvania/Abramson Cancer Center Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Thomas Jefferson University Hospital Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Memorial Sloan Kettering Rockville Centre Coordinator of this site? Confirm its status | Rockville Centre | United States | Unknown status |
| ProCure Proton Therapy Center-Seattle Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| University of Washington Medical Center Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Memorial Sloan Kettering Sleepy Hollow Coordinator of this site? Confirm its status | Sleepy Hollow | United States | Unknown status |
| ProCure Proton Therapy Center-Somerset Coordinator of this site? Confirm its status | Somerset | United States | Unknown status |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| MD Anderson Regional Care Center-Sugar Land Coordinator of this site? Confirm its status | Sugar Land | United States | Unknown status |
| MD Anderson Regional Care Center-The Woodlands Coordinator of this site? Confirm its status | The Woodlands | United States | Unknown status |
| Northwestern Medicine Cancer Center Warrenville Coordinator of this site? Confirm its status | Warrenville | United States | Unknown status |
| West Chester Hospital Coordinator of this site? Confirm its status | West Chester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.