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CompletedPhase 2NCT02773238
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedComputed Tomography and Computed Tomography

Plus 7 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 14, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?2 U.S. locations

Locations may change over time.

Who runs it?University of Washington

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
University of Washington
Interventions being studied
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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Treatment approach
Chemotherapy→Radiation therapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Fred Hutch/University of Washington Cancer ConsortiumSeattle, Washington
  • SCCA Proton Therapy CenterSeattle, Washington

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 14, 2024. Always confirm current availability with the study team.

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