Using FDG-PET During Radiation Therapy in Non-Small Cell Lung Cancer (HUM15709)
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|ClinicalTrials.gov Identifier: NCT01190527|
Recruitment Status : Completed
First Posted : August 27, 2010
Results First Posted : January 14, 2015
Last Update Posted : June 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Non-Small Cell Lung Cancer||Radiation: FDG-PET||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||January 6, 2015|
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.
- 2 Year Rate of Overall Local-Regional Tumor Control Using FGD-PET-CT During Radiation Therapy(RT) [ Time Frame: 2 years ]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 ]The number of patients for which dose escalation was possible will be reported.
- Percentage of Patients Alive at 2 Years [ Time Frame: 2 years ]Overall survival of all patients will be estimated
- The Number of Participants That Experience Lung Toxicity and Esophagitis [ Time Frame: 2 years ]The number of participants that experience RT (radiation therapy) induced lung toxicity, and grade 2 or greater (symptomatic) esophagitis, will be recorded.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01190527
|United States, Michigan|
|University of Michigan Cancer Center|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Shruti Jolly, M.D.||University of Michigan Rogel Cancer Center|