A Pilot Study of Response-Driven Adaptive Radiation Therapy for Patients With Locally Advanced Non-Small Cell Lung Cancer
NCT02492867 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49
Last updated 2024-09-03
Summary
Successful treatment of lung cancer with radiation therapy requires that the physicians determine exactly where the tumor is in the patient's body and seek to limit any unnecessary radiation to normal parts of the body. This study is designed to apply functional imaging, Fluorodeoxyglucose-Positron Emission Tomography (FDG-PET) ("a PET scan") and Ventilation/Perfusion Single Photon Emission Computerized Tomography (V/Q SPECT) ("a perfusion scan"), before treatment and then again during treatment to see if this scanning helps predict how well the treatment works and how well the lung functions during treatment. FDG-PET is a modern technology that uses small amounts of a radioactive glucose (FDG) to make images of the whole body and areas of active cancer. V/Q SPECT is an image mapping tool that helps assess how well the lungs are working. A Computerized Tomography (CT) will also be performed along with both of these procedures to help the researchers see clearly where the cancer or the healthy lung is located.
The researchers are also doing blood and urine tests in this study to look for markers to see if this helps them determine the patient's risk of developing side effects from radiation to the lungs. The researchers hope by using these types of tests that they can have more information to help decrease the amount of toxicity patients have from this type of treatment. The researchers hope that this study will help them in the future to design radiation treatment plans that provide the best treatment for each individual patient.
Conditions
- Carcinoma, Non-Small-Cell Lung
Interventions
- RADIATION
-
Response-driven Adaptive Radiation Therapy
- DRUG
-
AUC 2 concurrent with RT; AUC 6 during consolidation. Given IV
- DRUG
-
40 mg/m\^2 IV concurrent with RT; 200 mg/m\^2 during consolidation. Given IV
- DEVICE
-
FDG-PET
- DEVICE
-
V/Q SPECT
- DRUG
-
10 mg/kg during consolidation. Given IV
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
University of Michigan Rogel Cancer Center
lead OTHER
Principal Investigators
-
Shruti Jolly, M.D. · University of Michigan Rogel Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-01-14
- Primary Completion
- 2021-11-28
- Completion
- 2022-04-21
Countries
- United States
Study Locations
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