Using FDG-PET Acquired During the Course of Radiation Therapy to Individualize Adaptive Radiation Dose Escalation in Patients With Non-Small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- 2 Year Rate of Overall Local-Regional Tumor Control Using FGD-PET-CT During Radiation Therapy(RT)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 >
- •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/mm
- •absolute neutrophil count ≥ 1,500/mm
- •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.
排除标准
- •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.
结局指标
主要结局
2 Year Rate of Overall Local-Regional Tumor Control Using FGD-PET-CT During Radiation Therapy(RT)
时间窗: 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.
次要结局
- Number of Patients That Were Able to Receive Dose Escalation(2 Years)
- Percentage of Patients Alive at 2 Years(2 years)
- The Number of Participants That Experience Lung Toxicity and Esophagitis(2 years)