A Pilot Study of Response-Driven Adaptive Radiation Therapy for Patients With Locally Advanced Non-Small Cell Lung Cancer

Completed · Not applicable

Conditions studied: Carcinoma, Non-Small-Cell Lung

In brief

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.

Key facts

Study ID: NCT02492867
Run by: University of Michigan Rogel Cancer Center
People needed: 49
Starts: 2016-01-14
Expected to finish: 2022-04-21
Last updated by the study team: 2024-09-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients must have FDG-avid and pathologically proven Stage IIA-IIIB non-small cell lung cancer.
Patients must be considered unresectable or inoperable.
Patients must be 18 years of age or older.
Patients must have a Karnofsky performance (A measure general well-being and activities of daily life. Scores range between 0 and 100 where 100 represents normal and 0 represents death.) of score > or = to 70.
Patients must have adequate organ and marrow function.
Patient must be willing to use effective contraception if female with reproductive capability.
Patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines.

You may not qualify if…

Patients with any component of small cell lung carcinoma
Patients with evidence of a malignant pleural or pericardial effusion
Prior radiotherapy to the thorax such that composite radiation would significantly overdose critical structures, either per estimation of the treating radiation oncologist or defined by failure to meet normal tissue tolerance constraints
Patients cannot tolerate concurrent chemotherapy
Pregnant women are excluded from this study because radiation has the potential for teratogenic or abortifacient effects.
Prisoners are excluded for this study.

Where it is running

VA Ann Arbor Healthcare System — Ann Arbor, Michigan, United States
University of Michigan Cancer Center — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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