ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02773238
Recruitment Status : Recruiting
First Posted : May 16, 2016
Last Update Posted : May 1, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington

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.

Condition or disease Intervention/treatment Phase
Stage IIB Non-Small Cell Lung Carcinoma AJCC v7 Stage IIIA Non-Small Cell Lung Cancer AJCC v7 Stage IIIB Non-Small Cell Lung Cancer AJCC v7 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 Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Personalized Radiation Therapy Through Functional Lung Avoidance and Response-Adaptive Dose Escalation: Utilizing Multimodal Molecular Imaging to Improve the Therapeutic Ratio (FLARE RT)
Actual Study Start Date : May 20, 2016
Estimated Primary Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773238


Locations
United States, Washington
Fred Hutch/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Jing Zeng    206-598-4100    jzeng13@uw.edu   
Principal Investigator: Jing Zeng         
Sub-Investigator: Shilpen Patel         
Sub-Investigator: Ramesh Rengan         
Sub-Investigator: Stephen R. Bowen         
ProCure Proton Therapy Center-Seattle Recruiting
Seattle, Washington, United States, 98133
Contact: Jing Zeng    206-598-4100    jzeng13@uw.edu   
Principal Investigator: Jing Zeng         
Sub-Investigator: Shilpen Patel         
Sub-Investigator: Ramesh Rengan         
Sub-Investigator: Stephen R. Bowen         
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jing Zeng Fred Hutch/University of Washington Cancer Consortium

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT02773238     History of Changes
Other Study ID Numbers: 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 )
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Fluorodeoxyglucose F18
Technetium Tc 99m Sulfur Colloid
Technetium Tc 99m Aggregated Albumin
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action