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
5 other identifiers
interventional
330
1 country
30
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2014
Longer than P75 for phase_3
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 12, 2013
CompletedFirst Posted
Study publicly available on registry
November 25, 2013
CompletedStudy Start
First participant enrolled
February 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2028
December 18, 2024
December 1, 2024
13.8 years
November 12, 2013
December 13, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival
The time from study registration until death or last follow-up
From registration until death or last follow-up; analysis occurs after 390 deaths have been reported
Secondary Outcomes (2)
Progression-free survival
From registration to date of local failure, regional failure, distant failure, death from any cause, or until last follow-up. Analysis occurs after 390 deaths have been reported.
Adverse events
From start of treatment to end of follow-up
Study Arms (2)
Arm I (photon beam radiation therapy and chemotherapy)
ACTIVE COMPARATORPatients undergo photon beam radiation therapy 5 days per week for a total of 35 fractions and receive either paclitaxel\* IV over 1 hour and carboplatin\* IV weekly during radiation therapy or etoposide IV on days 1-5 and 29-33 and cisplatin IV on days 1, 8, 29, and 36. Patients with non-squamous cell cancer may receive pemetrexed IV and carboplatin IV on every 21 days. Patients who receive paclitaxel and carboplatin must complete 2 courses of consolidation therapy. CONSOLIDATION THERAPY: Beginning 3-6 weeks after chemoradiotherapy, patients receive either paclitaxel IV over 3 hours and carboplatin IV on day 1 or durvalumab IV every 2 weeks. Treatment repeats every 21 days for 2 courses or every 2 weeks for up to 12 months for durvalumab in the absence of disease progression or unacceptable toxicity. Patients with non-squamous cell carcinoma may receive durvalumab or pemetrexed IV and carboplatin IV on day 1 every 21 days for up to 4 courses.
Arm II (proton beam radiation therapy and chemotherapy)
EXPERIMENTALPatients undergo proton beam radiation therapy 5 days per week for a total of 35 fractions and receive either paclitaxel\* and carboplatin\*, etoposide and cisplatin, or pemetrexed and carboplatin (for non-squamous cell cancer patients only) as in Arm I. Patients who receive paclitaxel and carboplatin must complete 2 courses of consolidation therapy. CONSOLIDATION THERAPY: Beginning 3-6 weeks after chemoradiotherapy, patients receive either paclitaxel IV over 3 hours and carboplatin IV on day 1 or durvalumab IV every 2 weeks. Treatment repeats every 21 days for 2 courses or every 2 weeks for up to 12 months for durvalumab in the absence of disease progression or unacceptable toxicity. Patients with non-squamous cell carcinoma may receive durvalumab or pemetrexed IV and carboplatin IV on day 1 every 21 days for up to 4 courses.
Interventions
Given IV
Given IV
Given IV
Given IV
Given IV
Given IV
Undergo photon beam radiation therapy
Undergo proton beam radiation therapy
Ancillary studies
Ancillary studies
Eligibility Criteria
You may qualify if:
- 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
- +16 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Radiation Therapy Oncology Grouplead
- National Cancer Institute (NCI)collaborator
- NRG Oncologycollaborator
Study Sites (30)
University of Florida Health Science Center - Jacksonville
Jacksonville, Florida, 32209, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555, United States
Maryland Proton Treatment Center
Baltimore, Maryland, 21201, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Upper Chesapeake Medical Center
Bel Air, Maryland, 21014, United States
Central Maryland Radiation Oncology in Howard County
Columbia, Maryland, 21044, United States
Tate Cancer Center
Glen Burnie, Maryland, 21061, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Mass General/North Shore Cancer Center
Danvers, Massachusetts, 01923, United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
ProCure Proton Therapy Center-Somerset
Somerset, New Jersey, 08873, United States
Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Rockville Centre
Rockville Centre, New York, 11570, United States
Memorial Sloan Kettering Sleepy Hollow
Sleepy Hollow, New York, 10591, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267, United States
West Chester Hospital
West Chester, Ohio, 45069, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Tennessee Cancer Specialists-Dowell Springs
Knoxville, Tennessee, 37909, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
MD Anderson Regional Care Center-Katy
Houston, Texas, 77094, United States
MD Anderson Regional Care Center-Bay Area
Nassau Bay, Texas, 77058, United States
MD Anderson Regional Care Center-Sugar Land
Sugar Land, Texas, 77478, United States
MD Anderson Regional Care Center-The Woodlands
The Woodlands, Texas, 77384, United States
ProCure Proton Therapy Center-Seattle
Seattle, Washington, 98133, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Related Publications (1)
Ramella S, D'Angelillo RM. Proton beam or photon beam radiotherapy in the treatment of non-small-cell lung cancer. Lancet Oncol. 2020 Jul;21(7):873-875. doi: 10.1016/S1470-2045(20)30246-1. No abstract available.
PMID: 32615102DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhongxing Liao
NRG Oncology
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2013
First Posted
November 25, 2013
Study Start
February 3, 2014
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
October 1, 2028
Last Updated
December 18, 2024
Record last verified: 2024-12