Lung Cancer Clinical Trial

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

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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Full Description

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.

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Eligibility 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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

56

Study ID:

NCT02773238

Recruitment Status:

Active, not recruiting

Sponsor:

University of Washington

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There are 2 Locations for this study

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Fred Hutch/University of Washington Cancer Consortium
Seattle Washington, 98109, United States
SCCA Proton Therapy Center
Seattle Washington, 98133, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

56

Study ID:

NCT02773238

Recruitment Status:

Active, not recruiting

Sponsor:


University of Washington

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