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FLARE RT for Patients With Stage IIB-IIIB Non-small Cell Lung Cancer: Personalizing Radiation Therapy Using PET/CT and SPECT/CT Imaging

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ClinicalTrials.gov Identifier: NCT02773238
Recruitment Status : Recruiting
First Posted : May 16, 2016
Last Update Posted : May 8, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington

Tracking Information
First Submitted Date  ICMJE April 28, 2016
First Posted Date  ICMJE May 16, 2016
Last Update Posted Date May 8, 2020
Actual Study Start Date  ICMJE May 20, 2016
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2018)
Overall survival (OS) rate [ Time Frame: At 2 years ]
Will be compared to the 60 Gy cohort of Radiation Therapy Oncology Group 0617 for historical control. A one sample proportionality test using all patients who complete either functional lung avoidance and response-adaptive dose escalation (FLARE) radiation therapy (RT) treatment arm (standard dose arm in responders + dose escalation arm in non-responders) will be performed. Interim and final statistical analyses of OS will consist of Kaplan-Meier estimation and cox proportional hazard regression.
Original Primary Outcome Measures  ICMJE
 (submitted: May 11, 2016)
OS rate [ Time Frame: At 2 years ]
Will be compared to the 60 Gy cohort of RTOG 0617 for historical control. A one sample proportionality test using all patients who complete either FLARE RT treatment arm (standard dose arm in responders + dose escalation arm in non-responders) will be performed. Interim and final statistical analyses of OS will consist of Kaplan-Meier estimation and cox proportional hazard regression.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2018)
  • Incidence of pulmonary toxicity defined as Common Terminology Criteria for Adverse Events version 4 grade 2 or higher pneumonitis [ Time Frame: Up to 3 months ]
    Will be compared between patients receiving FLARE RT and historical rates.
  • Local-regional control as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria [ Time Frame: At 1 year ]
    Intrathoracic control of lung tumors assessed by post-radiotherapy computed tomography. Control will be defined as lack of progressive disease as defined by RECIST criteria. Interim and final statistical analyses of local control will consist of Kaplan-Meier estimation and cox proportional hazard regression.
  • Progression-free survival [ Time Frame: Up to 2 years ]
    Interim and final statistical analyses of local control will consist of Kaplan-Meier estimation and cox proportional hazard regression.
  • Change in pulmonary function-forced expiratory volume in 1 second (FEV1) [ Time Frame: Baseline to 3 months post-radiation therapy ]
    Pulmonary function tests (FEV1, liters) will be performed and change over time will be evaluated.
  • Change in pulmonary function (diffusing capacity of the lungs for carbon monoxide [DLCO]) [ Time Frame: Baseline to 3 months post-radiation therapy ]
    Pulmonary function tests (DLCO, % predicted) will be performed and change over time will be evaluated.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2016)
  • Change in pulmonary function-FEV1 [ Time Frame: Baseline to 3 months post-radiation therapy ]
    Pulmonary function tests (FEV1, liters) will be performed and change over time will be evaluated.
  • Change in pulmonary function-DLCO [ Time Frame: Baseline to 3 months post-radiation therapy ]
    Pulmonary function tests (DLCO, % predicted) will be performed and change over time will be evaluated.
  • Incidence of pulmonary toxicity defined as CTCAE v4 grade 2 or higher pneumonitis [ Time Frame: Up to 3 months ]
    Will be compared between patients receiving FLARE RT and historical rates.
  • Local-regional control as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria [ Time Frame: At 1 year ]
    Intrathoracic control of lung tumors assessed by post-radiotherapy CT. Control will be defined as lack of progressive disease as defined by RECIST criteria. Interim and final statistical analyses of local control will consist of Kaplan-Meier estimation and cox proportional hazard regression.
  • Progression-free survival [ Time Frame: Up to 2 years ]
    Interim and final statistical analyses of local control will consist of Kaplan-Meier estimation and cox proportional hazard regression.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE FLARE RT for Patients With Stage IIB-IIIB Non-small Cell Lung Cancer: Personalizing Radiation Therapy Using PET/CT and SPECT/CT Imaging
Official Title  ICMJE Personalized Radiation Therapy Through Functional Lung Avoidance and Response-Adaptive Dose Escalation: Utilizing Multimodal Molecular Imaging to Improve the Therapeutic Ratio (FLARE RT)
Brief Summary This phase II trial studies how well positron emission tomography (PET)/computed tomography (CT) and single positron emission computed tomography (SPECT)/CT imaging works in improving radiation therapy treatment in patients with stage IIB-IIIB non-small cell lung cancer. PET/CT imaging mid-way through treatment may be able to accurately show how well radiation therapy and chemotherapy are working. SPECT/CT imaging may be able to tell which parts of the lung tissue are healthier than others. Based on the result of the imaging, treatment adjustments may be made to the radiation therapy to improve survival and decrease toxicity.
Detailed Description

PRIMARY OBJECTIVE:

I. To test the superiority of 2 year (yr) overall survival (OS) in the functional lung avoidance and response-adaptive dose escalation (FLARE) radiation therapy (RT) patient cohort over the 60 gray (Gy) cohort of Radiation Therapy Oncology Group (RTOG) 0617 (57% 2yr OS) for historical control.

SECONDARY OBJECTIVE:

I. Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4 grade 2 or higher pneumonitis incidence from FLARE RT compared to historical controls (non-inferiority test).

II. 1 yr local control, progression-free survival, and pulmonary function test decline.

III. Identification of baseline fludeoxyglucose (FDG) PET/CT and mid-treatment FDG PET/CT imaging biomarkers for predicting patient survival.

IV. Identification of baseline perfusion SPECT/CT imaging biomarkers for predicting grade (G)2+ pneumonitis and pulmonary function tests (PFT) decline.

V. Collection of plasma and urine samples for future correlative studies between imaging biomarkers and cytokine biomarkers of radiation response in both tumor and normal tissue.

OUTLINE: This is a dose-escalation study of radiation therapy.

Patients undergo functional avoidance radiation therapy during weeks 1-3. Patients undergo fludeoxyglucose F-18 FDG PET/CT at baseline, 3 weeks, and 3 months post-radiation therapy and undergo technetium Tc-99m albumin aggregated (99mTc-MAA) and technetium Tc-99m sulfur colloid SPECT/CT radiation therapy at baseline and 3 months post-radiation therapy. Baseline PET/CT must be performed at University of Washington Medical Center/Seattle Cancer Care Alliance and be within one month of treatment start, therefore some patients may need to repeat a baseline PET/CT if their PET/CT is from an outside institution or > 1 month old. Patients not responding to treatment at 3 weeks, will receive an increased daily radiation therapy dosage.

After completion of study treatment, patients are followed up for 2 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Stage IIB Lung Non-Small Cell Carcinoma AJCC v7
  • Stage IIIA Lung Non-Small Cell Cancer AJCC v7
  • Stage IIIB Lung Non-Small Cell Cancer AJCC v7
Intervention  ICMJE
  • Procedure: Computed Tomography
    Undergo FDG PET/CT
    Other Names:
    • CAT
    • CAT Scan
    • Computerized Axial Tomography
    • computerized tomography
    • CT
    • CT SCAN
    • tomography
  • Procedure: Computed Tomography
    Undergo Tc-99m MAA or Tc-99m DTPA
    Other Names:
    • CAT
    • CAT Scan
    • Computerized Axial Tomography
    • computerized tomography
    • CT
    • CT SCAN
    • tomography
  • Radiation: Fludeoxyglucose F-18
    Undergo FDG PET/CT
    Other Names:
    • 18FDG
    • FDG
    • fludeoxyglucose F 18
    • Fludeoxyglucose F18
    • Fluorine-18 2-Fluoro-2-deoxy-D-Glucose
    • Fluorodeoxyglucose F18
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Procedure: Positron Emission Tomography
    Undergo FDG PET/CT
    Other Names:
    • Medical Imaging, Positron Emission Tomography
    • PET
    • PET Scan
    • Positron Emission Tomography Scan
    • Positron-Emission Tomography
    • proton magnetic resonance spectroscopic imaging
  • Radiation: Radiation Therapy
    Undergo functional avoidance radiation therapy
    Other Names:
    • Cancer Radiotherapy
    • Irradiate
    • Irradiated
    • irradiation
    • RADIATION
    • Radiotherapeutics
    • radiotherapy
    • RT
    • Therapy, Radiation
  • Procedure: Single Photon Emission Computed Tomography
    Undergo Tc-99m MAA or Tc-99m Undergo Tc-99m sulfur colloid SPECT/CT
    Other Names:
    • Medical Imaging, Single Photon Emission Computed Tomography
    • Single Photon Emission Tomography
    • single-photon emission computed tomography
    • SPECT
    • SPECT imaging
    • SPECT SCAN
    • SPET
    • tomography, emission computed, single photon
    • Tomography, Emission-Computed, Single-Photon
  • Radiation: Technetium Tc-99m Albumin Aggregated
    Undergo Tc-99m MAA SPECT/CT
    Other Names:
    • Tc 99m-labeled MAA
    • Technetium Tc 99m-Labeled Macroaggregated Albumin
  • Radiation: Technetium Tc-99m Sulfur Colloid
    Undergo Tc-99m sulfur colloid
    Other Names:
    • Tc 99m sulfur colloid
    • Tc-99m SC
    • technetium Tc 99m sulfur colloid
Study Arms  ICMJE Experimental: Treatment
Patients undergo functional avoidance radiation therapy during weeks 1-3. Patients undergo fludeoxyglucose F-18 FDG PET/CT at baseline, 3 weeks, and 3 months post-radiation therapy and undergo technetium Tc-99m albumin aggregated (99mTc-MAA) and technetium Tc-99m sulfur colloid SPECT/CT radiation therapy at baseline and 3 months post-radiation therapy. Baseline PET/CT must be performed at University of Washington Medical Center/Seattle Cancer Care Alliance and be within one month of treatment start, therefore some patients may need to repeat a baseline PET/CT if their PET/CT is from an outside institution or > 1 month old. Patients not responding to treatment at 3 weeks, will receive an increased daily radiation therapy dosage.
Interventions:
  • Procedure: Computed Tomography
  • Procedure: Computed Tomography
  • Radiation: Fludeoxyglucose F-18
  • Other: Laboratory Biomarker Analysis
  • Procedure: Positron Emission Tomography
  • Radiation: Radiation Therapy
  • Procedure: Single Photon Emission Computed Tomography
  • Radiation: Technetium Tc-99m Albumin Aggregated
  • Radiation: Technetium Tc-99m Sulfur Colloid
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 20, 2020)
60
Original Estimated Enrollment  ICMJE
 (submitted: May 11, 2016)
50
Estimated Study Completion Date  ICMJE December 1, 2022
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pathologically proven (either histologic or cytologic) diagnosis of stage IIB-IIIB non-small cell lung cancer (NSCLC); according to American Joint Committee on Cancer (AJCC) staging, 7th edition

    • Staging workup must include: brain imaging (CT head or magnetic resonance imaging [MRI] brain) and PET/CT
    • Pleural effusions must have cytology to rule out malignant involvement unless too small to undergo thoracentesis per radiology
  • Patients must be considered unresectable or inoperable
  • Patient must not have received prior radiation for this lung cancer
  • Patients must be having concurrent chemotherapy
  • Nodal recurrences can be treated on this protocol but prior curative surgery for lung cancer must have been at least 6 months prior to the nodal recurrence
  • Patients must have measurable or evaluable disease that is FDG avid with standardized uptake value (SUV) > 3 on PET/CT
  • Zubrod performance status 0-1
  • PFTs including forced expiratory volume in 1 second (FEV1) within 26 weeks prior to registration; for FEV1, the best value obtained pre- or post-bronchodilator must be >= 0.8 liters/second or >= 50% predicted
  • Blood cell count (CBC)/differential obtained within 8 weeks prior to registration on study
  • Absolute neutrophil count (ANC) >= 1,800 cells/mm^3
  • Platelets >= 100,000 cells/mm^3
  • Hemoglobin >= 10.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin (Hgb) >= 10.0 g/dl is acceptable)
  • Serum creatinine within normal institutional limits or creatinine clearance >= 40 ml/min
  • Bilirubin must be within or below normal institutional limits
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x the institutional upper limit of normal (IULN)
  • Patient must sign study specific informed consent prior to study entry

Exclusion Criteria:

  • > 10% unintentional weight loss within the past month
  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; non-invasive conditions such as carcinoma in situ of the breast, oral cavity, or cervix are all permissible
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02773238
Other Study ID Numbers  ICMJE 9599
NCI-2016-00543 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
9599 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
R01CA204301 ( U.S. NIH Grant/Contract )
RG3116002 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Jing Zeng Fred Hutch/University of Washington Cancer Consortium
PRS Account University of Washington
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP