Study of Positron Emission Tomography and Computed Tomography in Guiding Radiation Therapy in Patients With Stage III Non-small Cell Lung Cancer
NCT ID: NCT01507428
Last Updated: 2021-04-29
Study Results
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Basic Information
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UNKNOWN
PHASE2
138 participants
INTERVENTIONAL
2012-02-22
2021-08-01
Brief Summary
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Detailed Description
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I. To determine whether tumor dose can be escalated to improve the freedom from local-regional progression-free (LRPF) rate at 2 years when an individualized adaptive radiation treatment (RT) plan is applied by the use of a fludeoxyglucose F 18 (FDG)-positron emission tomography (PET)/computed tomography (CT) scan acquired during the course of fractionated RT in patients with inoperable stage III non-small cell lung cancer (NSCLC). (National Surgical Adjuvant Breast and Bowel Project \[NSABP\], Radiation Therapy Oncology Group \[RTOG\], Gynecologic Oncology Group \[GOG\] \[NRG\] Oncology) II. To determine whether the relative change in standard uptake value (SUV) peak from the baseline to the during-treatment FDG-PET/CT, defined as (during-treatment SUVpeak - baseline SUVpeak)/baseline SUV peak x 100%, can predict the LRPF rate with a 2-year follow up. (Eastern Cooperative Oncology Group \[ECOG\]-American College of Radiology Imaging Network \[ACRIN\])
SECONDARY OBJECTIVES:
I. To determine whether an individualized dose escalation improves overall survival (OS), progression-free survival (PFS), lung cancer cause-specific survival, and delays time to local-regional progression compared to a conventional RT plan. (NRG Oncology) II. To compare the rate of severe (grade 3+ Common Terminology Criteria for Adverse Events \[CTCAE\], v. 4) radiation-induced lung toxicity (RILT) defined as severe RILT pneumonitis or clinical fibrosis. (NRG Oncology) III. To compare other severe adverse events, including grade 3+ (CTCAE, v. 4) esophagitis or grade 2 pericardial effusions, or any grade cardiac adverse events related to chemoradiation between a PET/CT-guided adaptive approach and a conventional RT plan. (NRG Oncology) IV. To evaluate the association of baseline 18F-fluoromisonidazole (FMISO), a PET/CT imaging agent uptake (tumor-to-blood pool ratio) with LRPF (i.e., the assessment of using baseline FMISO-PET uptake as a prognostic marker). (ECOG-ACRIN) V. To determine if the relative change in SUVpeak from baseline to during-treatment FDG-PET/CT and/or baseline FMISO uptake (tumor-to-blood pool ratio) predicts the differential benefit of the adaptive therapy, i.e., the association of uptake parameters with LRPF rate depending on the assigned treatment thus, assessing if these uptake parameters can be useful in guiding therapies, i.e., predictive markers. (ECOG-ACRIN) VI. To determine if other PET-imaging uptake parameters (SUV peak during-treatment for FDG-PET, maximum SUV, or relative change of maximum SUVs from pre- to during-treatment FDG-PET/CT, change in metabolic tumor volume, FMISO total hypoxic volume, FMISO tumor to mediastinum ratio, EORTC or University of Michigan/Kong's response criteria) will predict OS, LRPF rate, and lung cancer cause-specific (LCS) survival as well as to explore the optimal threshold for differentiating responders from non-responders. (ECOG-ACRIN)
CORRELATIVE SCIENCE OBJECTIVES:
I. To study whether a model of combining current clinical and/or imaging factors with blood markers, including osteopontin (OPN) \[for hypoxia marker\], carcinoembryonic antigen (CEA) and cytokeratin fragment (CYFRA) 21-1 (for tumor burden), and interleukin (IL)-6 (inflammation) will predict the 2-year LRPF rate and survival better than a current model using clinical factors and radiation dose as well as imaging factors.
II. To determine/validate whether a model of combining mean lung dose (MLD), transforming growth factor beta1 (TGF beta1) and IL-8 will improve the predictive accuracy for clinical significant RILT better comparing to the current model of using MLD alone.
III. To explore, in a preliminary manner, whether proteomic and genomic markers in the blood prior to and during the early course of treatment are associated with tumor response after completion of treatment, LRPF rate, PFS, OS, and pattern of failure and treatment-related adverse events, such as radiation pneumonitis, esophagitis, and pericardial effusion. (exploratory)
OUTLINE:
Prior to treatment, patients undergo fludeoxyglucose F 18 (FDG) positron emission tomography (PET) and computed tomography (CT) scans at baseline and periodically during study. A subset of patients also undergo 18F-fluoromisonidazole PET/CT scan at baseline. Patients are randomized to 1 of 2 treatment arms:
ARM I (standard chemoradiotherapy): Patients undergo radiotherapy once daily (QD) 5 days a week for 30 fractions. Patients also receive paclitaxel intravenously (IV) over 1 hour and carboplatin IV over 30 minutes once weekly for 6 weeks. Patients undergo FDG-PET/CT imaging between fractions 18 and 19.
ARM II (experimental chemoradiotherapy): Patients undergo an individualized dose of image-guided radiotherapy QD 5 days a week for 30 fractions and undergo 18 F FDG-PET/CT between fractions 18 and 19. Based on the scan results, patients undergo individualized adaptive radiotherapy for the final 9 fractions. Patients also receive paclitaxel and carboplatin as in Arm I.
CONSOLIDATION CHEMOTHERAPY: Beginning 4-6 weeks after chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 1 month, every 3 months for 1 year, every 6 months for 2 years, and then annually for 2 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm I (standard chemoradiotherapy)
Patients undergo radiotherapy QD 5 days a week for 30 fractions. Patients also receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes once weekly for 6 weeks. Patients undergo FDG-PET/CT imaging between fractions 18 and 19.
18F-Fluoromisonidazole
Undergo FMISO PET/CT (Correlative studies)
Carboplatin
Given IV
Computed Tomography
Undergo FDG PET/CT
Computed Tomography
Undergo FMISO PET/CT (Correlative studies)
External Beam Radiation Therapy
Undergo radiotherapy
Fludeoxyglucose F-18
Undergo FDG PET/CT
Laboratory Biomarker Analysis
Correlative studies
Paclitaxel
Given IV
Positron Emission Tomography
Undergo FDG PET/CT
Positron Emission Tomography
Undergo FMISO PET/CT (Correlative studies)
Arm II (experimental chemoradiotherapy)
Patients undergo an individualized dose of image-guided radiotherapy QD 5 days a week for 30 fractions and undergo 18 F FDG-PET/CT between fractions 18 and 19. Based on the scan results, patients undergo individualized adaptive radiotherapy for the final 9 fractions. Patients also receive paclitaxel and carboplatin as in Arm I.
18F-Fluoromisonidazole
Undergo FMISO PET/CT (Correlative studies)
Carboplatin
Given IV
Computed Tomography
Undergo FDG PET/CT
Computed Tomography
Undergo FMISO PET/CT (Correlative studies)
Fludeoxyglucose F-18
Undergo FDG PET/CT
Image-Guided Adaptive Radiation Therapy
Undergo individualized adaptive radiotherapy
Laboratory Biomarker Analysis
Correlative studies
Paclitaxel
Given IV
Positron Emission Tomography
Undergo FDG PET/CT
Positron Emission Tomography
Undergo FMISO PET/CT (Correlative studies)
Interventions
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18F-Fluoromisonidazole
Undergo FMISO PET/CT (Correlative studies)
Carboplatin
Given IV
Computed Tomography
Undergo FDG PET/CT
Computed Tomography
Undergo FMISO PET/CT (Correlative studies)
External Beam Radiation Therapy
Undergo radiotherapy
Fludeoxyglucose F-18
Undergo FDG PET/CT
Image-Guided Adaptive Radiation Therapy
Undergo individualized adaptive radiotherapy
Laboratory Biomarker Analysis
Correlative studies
Paclitaxel
Given IV
Positron Emission Tomography
Undergo FDG PET/CT
Positron Emission Tomography
Undergo FMISO PET/CT (Correlative studies)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must be clinical American Joint Committee on Cancer (AJCC) stage IIIA or IIIB (AJCC, 7th ed.) with non-operable disease; non-operable disease will be determined by a multi-disciplinary treatment team, involving evaluation by at least 1 thoracic surgeon within 8 weeks prior to registration; Note: For patients who are clearly nonresectable, the case can be determined by the treating radiation oncologist and a medical oncologist, or pulmonologist
* Patients with multiple, ipsilateral pulmonary nodules (T3 or T4) are eligible if a definitive course of daily fractionated radiation therapy (RT) is planned
* History/physical examination, including documentation of weight, within 2 weeks prior to registration
* FDG-PET/CT scan for staging and RT plan within 4 weeks prior to registration
* CT scan or sim CT of chest and upper abdomen (IV contrast is recommended unless medically contraindicated) within 6 weeks prior to registration
* CT scan of the brain (contrast is recommended unless medically contraindicated) or MRI of the brain within 6 weeks prior to registration
* Pulmonary function tests, including diffusion capacity of carbon monoxide (DLCO), within 6 weeks prior to registration; patients must have forced expiratory volume in 1 second (FEV1) \>= 1.2 Liter or \>= 50% predicted without bronchodilator
* Zubrod performance status 0-1
* Able to tolerate PET/CT imaging required to be performed at an American College of Radiology (ACR) Imaging Core Laboratory (Lab) qualified facility
* Absolute neutrophil count (ANC) \>= 1,500 cells/mm\^3 (within 2 weeks prior to registration on study)
* Platelets \>= 100,000 cells/mm\^3 (within 2 weeks prior to registration on study)
* Hemoglobin (Hgb) \>= 10.0 g/dL (note: the use of transfusion or other intervention to achieve Hgb \>= 10.0 g/dL is acceptable) (within 2 weeks prior to registration on study)
* Serum creatinine within normal institutional limits or a creatinine clearance \>= 60 ml/min within 2 weeks prior to registration
* Negative serum or urine pregnancy test within 3 days prior to registration for women of childbearing potential
* Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study
* The patient must provide study-specific informed consent prior to study entry
Exclusion Criteria
* Patients with evidence of a malignant pleural or pericardial effusion are excluded
* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
* Prior systemic chemotherapy for the study cancer; 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
* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol
* Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol
* Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
* Poorly controlled diabetes (defined as fasting glucose level \> 200 mg/dL) despite attempts to improve glucose control by fasting duration and adjustment of medications; patients with diabetes will preferably be scheduled in the morning and instructions for fasting and use of medications will be provided in consultation with the patients' primary physicians
* Patients with T4 disease with radiographic evidence of massive invasion of a large pulmonary artery and tumor causing significant narrowing and destruction of that artery are excluded
18 Years
ALL
No
Sponsors
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NRG Oncology
OTHER
National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Feng-Ming (Spring) P Kong
Role: PRINCIPAL_INVESTIGATOR
NRG Oncology
Locations
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Cleveland Clinic Foundation
Cleveland, Ohio, United States
Stanford Cancer Institute Palo Alto
Palo Alto, California, United States
Augusta University Medical Center
Augusta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Commack
Commack, New York, United States
Memorial Sloan Kettering Westchester
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Memorial Sloan Kettering Sleepy Hollow
Sleepy Hollow, New York, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, United States
Case Western Reserve University
Cleveland, Ohio, United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, United States
Cleveland Clinic Cancer Center Independence
Independence, Ohio, United States
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, United States
Cleveland Clinic Cancer Center Strongsville
Strongsville, Ohio, United States
Cleveland Clinic Wooster Family Health and Surgery Center
Wooster, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Reading Hospital
West Reading, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
McGill University Department of Oncology
Montreal, Quebec, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
Countries
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References
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Kong FS, Hu C, Pryma DA, Duan F, Matuszak M, Xiao Y, Ten Haken R, Siegel MJ, Hanna L, Curran WJ, Dunphy M, Gelblum D, Piert M, Jolly S, Robinson CG, Quon A, Loo BW, Srinivas S, Videtic GM, Faria SL, Ferguson C, Dunlap NE, Kundapur V, Paulus R, Siegel BA, Bradley JD, Machtay M. Primary Results of NRG-RTOG1106/ECOG-ACRIN 6697: A Randomized Phase II Trial of Individualized Adaptive (chemo)Radiotherapy Using Midtreatment 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in Stage III Non-Small Cell Lung Cancer. J Clin Oncol. 2024 Nov 20;42(33):3935-3946. doi: 10.1200/JCO.24.00022. Epub 2024 Oct 4.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NCI-2012-00107
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000721619
Identifier Type: -
Identifier Source: secondary_id
RTOG-1106/ACRIN-6697
Identifier Type: -
Identifier Source: secondary_id
RTOG-1106
Identifier Type: OTHER
Identifier Source: secondary_id
RTOG-1106
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2012-00107
Identifier Type: -
Identifier Source: org_study_id
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