NCT02773238

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

Personalized Radiation Therapy Through Functional Lung Avoidance and Response-Adaptive Dose Escalation: Utilizing Multimodal Molecular Imaging to Improve the Therapeutic Ratio (FLARE RT)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• 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

Interventions

Type	Name	Description
PROCEDURE	Computed Tomography	Undergo FDG PET/CT
PROCEDURE	Computed Tomography	Undergo Tc-99m MAA or Tc-99m DTPA
RADIATION	Fludeoxyglucose F-18	Undergo FDG PET/CT
OTHER	Laboratory Biomarker Analysis	Correlative studies
PROCEDURE	Positron Emission Tomography	Undergo FDG PET/CT
RADIATION	Radiation Therapy	Undergo functional avoidance radiation therapy
PROCEDURE	Single Photon Emission Computed Tomography	Undergo Tc-99m MAA or Tc-99m Undergo Tc-99m sulfur colloid SPECT/CT
RADIATION	Technetium Tc-99m Albumin Aggregated	Undergo Tc-99m MAA SPECT/CT
RADIATION	Technetium Tc-99m Sulfur Colloid	Undergo Tc-99m sulfur colloid

Timeline

• Start date: 2016-05-20
• Primary completion: 2023-06-01
• Completion: 2023-12-01
• First posted: 2016-05-16
• Last updated: 2024-08-14
• Results posted: 2024-08-14

Locations

2 sites across 1 country: United States