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

University of Washington

Status and phase

Completed

Phase 2

Conditions

Stage IIIB Lung Non-Small Cell Cancer AJCC v7

Stage IIB Lung Non-Small Cell Carcinoma AJCC v7

Stage IIIA Lung Non-Small Cell Cancer AJCC v7

Treatments

Radiation: Radiation Therapy

Procedure: Computed Tomography

Radiation: Technetium Tc-99m Albumin Aggregated

Procedure: Single Photon Emission Computed Tomography

Other: Laboratory Biomarker Analysis

Radiation: Fludeoxyglucose F-18

Procedure: Positron Emission Tomography

Radiation: Technetium Tc-99m Sulfur Colloid

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02773238

R01CA204301 (U.S. NIH Grant/Contract)

RG3116002 (Other Identifier)

9599 (Other Identifier)

NCI-2016-00543 (Registry Identifier)

Details and patient eligibility

About

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.

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.

Enrollment

51 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

51 participants in 1 patient group

Treatment

Experimental group

Description:

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.

Treatment: