Using FDG-PET During Radiation Therapy in Non-Small Cell Lung Cancer
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | August 2008 |
| End Date: | February 2017 |
Using FDG-PET Acquired During the Course of Radiation Therapy to Individualize Adaptive Radiation Dose Escalation in Patients With Non-Small Cell Lung Cancer
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.
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.
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 (American Joint Committee on Cancer) 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 (White Blood Cell) > 3,000/mm3.
- absolute neutrophil count ≥ 1,500/mm3.
- platelets > 100,000/mm3
- total bilirubin ≤ 3.0 mg/dl.
- AST ( Aspartate Aminotransferase or SGOT) and ALT (Alanine Transaminase or 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.
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