Lung Cancer Clinical Trial

Comparing Photon Therapy To Proton Therapy To Treat Patients With Lung Cancer

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.

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Full Description

PRIMARY OBJECTIVES:

I. To compare the overall survival (OS) in patients with stage II-IIIB non-small cell lung cancer (NSCLC) after image guided, motion-managed photon radiotherapy (Arm 1) or after image guided, motion-managed proton radiotherapy (Arm 2) both given with concurrent platinum- based chemotherapy.

II. To compare the cardiac toxicity and lymphocyte reduction (lymphopenia) definitely, probably, or possibly related to treatment between the 2 arms.

SECONDARY OBJECTIVES:

I. To compare 2-year progression-free survival (PFS) between the 2 arms. II. To compare the development of grade 3 or higher adverse events not included above that are definitely, probably, or possibly related to treatment.

III. To compare differences between the two arms in quality of life (QOL) based primarily on the development of shortness of breath at 6 months and secondarily on the development of sore throat at the end of chemoradiotherapy (chemoRT) (as measured by the lung cancer module of the MD Anderson Symptom Inventory [MDASI-Lung]), as well as breathing related functioning impairments as measured by the Shortness Breath Questionnaire [SOBQ].

IV. To compare cost-effectiveness outcomes between the 2 arms. V. To compare pulmonary function changes by treatment arms and response. VI. To explore the most appropriate and clinically relevant technological parameters to ensure quality and effectiveness throughout radiation therapy processes, including imaging, simulation, patient immobilization, target and critical structure definition, treatment planning, image guidance and delivery.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo photon beam radiation therapy 5 days per week for a total of 35 fractions and receive either paclitaxel* intravenously (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 cancera may receive pemetrexed IV and carboplatin IV on every 21 days.

ARM II: Patients 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.

*In both arms, 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.

After completion of study treatment, patients are followed up at 4-8 weeks, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

330

Study ID:

NCT01993810

Recruitment Status:

Recruiting

Sponsor:

Radiation Therapy Oncology Group

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There are 29 Locations for this study

See Locations Near You

University of Florida Health Science Center - Jacksonville
Jacksonville Florida, 32209, United States More Info
Site Public Contact
Contact
412-339-5294
[email protected]
Bradford S. Hoppe
Principal Investigator
Northwestern Medicine Cancer Center Warrenville
Warrenville Illinois, 60555, United States
Maryland Proton Treatment Center
Baltimore Maryland, 21201, United States More Info
Site Public Contact
Contact
410-369-5226
[email protected]
Charles B. Simone
Principal Investigator
University of Maryland/Greenebaum Cancer Center
Baltimore Maryland, 21201, United States More Info
Site Public Contact
Contact
800-888-8823
Charles B. Simone
Principal Investigator
Upper Chesapeake Medical Center
Bel Air Maryland, 21014, United States More Info
Site Public Contact
Contact
443-643-3010
Jack J. Hong
Principal Investigator
Central Maryland Radiation Oncology in Howard County
Columbia Maryland, 21044, United States More Info
Site Public Contact
Contact
443-546-1300
Charles B. Simone
Principal Investigator
Tate Cancer Center
Glen Burnie Maryland, 21061, United States More Info
Site Public Contact
Contact
410-553-8100
Charles B. Simone
Principal Investigator
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 More Info
Site Public Contact
Contact
800-600-3606
[email protected]
Jeffrey D. Bradley
Principal Investigator
Washington University School of Medicine
Saint Louis Missouri, 63110, United States More Info
Site Public Contact
Contact
800-600-3606
[email protected]
Jeffrey D. Bradley
Principal Investigator
Memorial Sloan Kettering Basking Ridge
Basking Ridge New Jersey, 07920, United States More Info
Site Public Contact
Contact
212-639-7592
Abraham J. Wu
Principal Investigator
ProCure Proton Therapy Center-Somerset
Somerset New Jersey, 08873, United States
Memorial Sloan Kettering Commack
Commack New York, 11725, United States More Info
Site Public Contact
Contact
212-639-7592
Abraham J. Wu
Principal Investigator
Memorial Sloan Kettering Westchester
Harrison New York, 10604, United States More Info
Site Public Contact
Contact
212-639-7592
Abraham J. Wu
Principal Investigator
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Site Public Contact
Contact
212-639-7592
Abraham J. Wu
Principal Investigator
Memorial Sloan Kettering Rockville Centre
Rockville Centre New York, 11570, United States More Info
Site Public Contact
Contact
212-639-7592
Abraham J. Wu
Principal Investigator
Memorial Sloan Kettering Sleepy Hollow
Sleepy Hollow New York, 10591, United States
University of Cincinnati Medical Center
Cincinnati Ohio, 45267, United States More Info
Emily Daugherty, MD
Principal Investigator
West Chester Hospital
West Chester Ohio, 45069, United States More Info
Emily Daugherty, MD
Principal Investigator
University of Pennsylvania/Abramson Cancer Center
Philadelphia Pennsylvania, 19104, United States More Info
Site Public Contact
Contact
800-474-9892
Samuel Swisher-McClure
Principal Investigator
Thomas Jefferson University Hospital
Philadelphia Pennsylvania, 19107, United States
Tennessee Cancer Specialists-Dowell Springs
Knoxville Tennessee, 37909, United States More Info
Site Public Contact
Contact
865-244-3209
J. B. Wilkinson
Principal Investigator
M D Anderson Cancer Center
Houston Texas, 77030, United States More Info
Site Public Contact
Contact
877-312-3961
Quynh-Nhu Nguyen
Principal Investigator
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 More Info
Site Public Contact
Contact
412-339-5294
[email protected]
Ramesh Rengan
Principal Investigator
University of Washington Medical Center
Seattle Washington, 98195, United States More Info
Site Public Contact
Contact
800-804-8824
Ramesh Rengan
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

330

Study ID:

NCT01993810

Recruitment Status:

Recruiting

Sponsor:


Radiation Therapy Oncology Group

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