Using FDG-PET During Radiation Therapy in Non-Small Cell Lung Cancer (HUM15709)
Successful treatment of non-small cell lung cancer with radiation therapy requires that the physicians determine exactly where the tumor is in your body, and protect your normal tissue. This study is designed to apply functional imaging, Fluorodeoxyglucose-Positron Emission Tomography (FDG-PET) before treatment, and then again during treatment to see if the procedure helps predict how well the treatment works for your cancer and how well your lung functions during treatment. FDG-PET is a modern technology that uses small amounts of a radioactive glucose (FDG) to make images of your whole body and areas of active cancer. A Computerized Tomography (CT) will also be performed along with both of these procedures to help the researchers see clearly where your cancer or your healthy lung is located. The study will help the investigator determine whether an adaptive plan that is applied based on repeat PET-CT imaging during the course of radiation therapy (during RT), can show if there is an improvement in treatment outcome compared to those treated with standard radiation therapy. This adaptive plan may allow your doctor to escalate the dose per treatment and the total dose of your treatment based on the risk of damage to your healthy lung tissue. While increasing the radiation dose, but limiting the toxicity to normal lung tissue, the researchers hope to improve your tumor control.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Using FDG-PET Acquired During the Course of Radiation Therapy to Individualize Adaptive Radiation Dose Escalation in Patients With Non-Small Cell Lung Cancer|
- Percentage of Patients With Overall Local-Regional Tumor Control at 2 Years Using FGD-PET-CT During Radiation Therapy(RT) [ Time Frame: 2-5 years ] [ Designated as safety issue: No ]Use FGD-PET-CT based adaptive radiation to deliver a higher total dose to the active tumor to determine if it will improve the local-regional tumor control and progression-free survival in patients, without increasing the normal tissue complication probability (NTCP) of the lung.
- Number of Patients That Were Able to Receive Dose Escalation [ Time Frame: 2 Years ] [ Designated as safety issue: No ]Total biological equivalent dosing difference between the 6-week prescribed plan using pre-RT imaging, will be compared to the dose delivered using the adaptive planning technique. At a minimum, the number of patients for which dose escalation was possible will be reported, along with the mean and standard deviation in the dose increase for the population.
- Correlation Between Pre-Radiation Therapy Tumor Sizes [ Time Frame: 2-5 years ] [ Designated as safety issue: No ]Correlations between pre-radiation therapy tumor sizes, distance from important anatomical structures and the dose increase, may be explored using the rank method of Spearman. Overall survival of all patients will be estimated using the product-limit method of Kaplan and Meier.
- Toxicities [ Time Frame: 2-5 years ] [ Designated as safety issue: No ]Toxicities will be reported as proportions with exact binomial confidences intervals. Standard unconditional logistic regression techniques will be used to explore potential associations between the levels of transforming growth factor beta one, and other molecules the occurrence of treatment-related toxicity. The relationship will be explored by dichotomizing toxicity events by meaningful grade and/or by the type of toxicity (e.g. pneumonitis vs. fibrosis.
|Study Start Date:||August 2008|
|Estimated Study Completion Date:||August 2015|
|Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
All subjects will have the same course of treatment, the study treatment.
This study is designed to apply functional imaging, Fluorodeoxyglucose-Positron Emission Tomography (FDG-PET) before treatment and again during treatment to see if it helps predict how well the treatment works for the cancer. The standard of care for patients with stage III unresectable NSCLC is combined chemoradiotherapy. This study will seek to determine 2 year local-regional progression free survival in patients with non-small cell lung cancer (NSCLC) when an adaptive plan is applied based on repeat PET-CT imaging during the course of radiation therapy (during RT), and investigate if there is an improvement compared to those treated with conventional radiation therapy without field and/or dose modification. The investigators hypothesize that during-RT, PET-CT-based adaptive therapy will allow them to dose escalate in the majority of patients and meet the dose limits of normal structures, thus improving local tumor control without increasing toxicity.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01190527
|United States, Michigan|
|University of Michigan Cancer Center|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Matthew Stenmark, M.D.||University of Michigan Cancer Center|