Overview

This trial is active, not recruiting.

Condition non-small cell lung cancer
Treatment adaptive radiation
Sponsor University of Michigan Cancer Center
Start date August 2008
End date August 2014
Trial size 42 participants
Trial identifier NCT01190527, UMCC 2007.123

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
All subjects will have the same course of treatment, the study treatment
adaptive radiation
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.

Primary Outcomes

Measure
Using FGD-PET-CT During Radiation Therapy(RT)
time frame: 2-5 years

Secondary Outcomes

Measure
Dose Escalation
time frame: 2-5 years
Correlation Between Pre-Radiation Therapy Tumor Sizes
time frame: 2-5 years
Toxicities
time frame: 2-5 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients must have FDG-avid and pathologically proven non-small cell lung cancer. If pathology not definitive, the patient needs to have a clinically diagnosed non-small cell lung cancer, which is also FDG-avid. - Patients must be 18 years of age or older. - Patients must have Karnofsky performance score > 60. - Patients must have clinical AJCC Stage I-IIIB, with unresectable or inoperable disease. - Patients must have no evidence of a malignant pleural or pericardial effusion - Patients must have hemoglobin > 10 gm/dl. Transfusions or medications may be used to achieve this criterion. - Patients must have reasonable organ and marrow functions as defined below if chemotherapy is considered: - WBC > 3,000/mm3. - absolute neutrophil count ≥ 1,500/mm3. - platelets > 100,000/mm3 - total bilirubin ≤ 3.0 mg/dl. - AST (SGOT) and ALT (SGPT) < 4 X institutional upper limit of normal. - creatinine ≤ 2.0 mg/dl. - Patients must not have serious intercurrent diseases per the judgment of the treating physician. - 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. Exclusion Criteria: - Patients with any component of small cell lung carcinoma are excluded from this study. - 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. - Pregnant women are excluded from this study because radiation has the potential for teratogenic or abortifacient effects. - Prisoners are excluded for this study.

Additional Information

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
Principal investigator Feng-Ming Kong, MD, Ph.D
Trial information was received from ClinicalTrials.gov and was last updated in February 2013.
Information provided to ClinicalTrials.gov by University of Michigan Cancer Center.