Expedited Laser Interstitial Thermal Therapy and Chemoradiation for Patients With Newly Diagnosed High Grade Gliomas
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Study safety as determined by the number of patients who experience pre-specified adverse events
研究概览
简要总结
The investigators of this study want to see if shortening the total treatment time for brain tumors is safe.The treatment for participant's brain tumors is laser surgery (Laser Interstitial Thermal Therapy (LITT)) followed by radiation with chemotherapy. For participants, the total time of treatment from surgery to the end of radiation and chemotherapy is about l 0 weeks long. This study asks whether it is safe to shorten the total treatment to 7 weeks.
To shorten the total treatment time, investigators want to see if it is safe to start radiation with chemotherapy within 5 days after surgery. Usually patients start their radiation with chemotherapy about 21-28 days after the surgery.
Shortening the total time of treatment may allow investigators to kill the cancer cells more effectively.
详细描述
Primary Objective To determine the safety and feasibility of reducing the time interval between LITT and the start of chemoradiation to ≤ 7 days.
The primary endpoint (binary) for safety/feasibility will be defined as the occurrence of one or more of the following within each patient during a window of observation from the completion LITT to the end of radiation:
- Wound dehiscence, grade 3 {CTCAE v4.0)
- Seizures, grade 3 (CTCAE v4.0) in patients without a prior history of seizures and on adequate anti-seizure medications
- Cerebral edema, grade 4 (CTCAE v4.0)
- Failure to complete of 60 Grays (Gy) of radiation
Secondary Objective(s) To estimate the proportion of patients requiring adjustments in radiation plans post-LITT.
Secondary Endpoint: Requirement of an adjustment in the radiation plan to account for post-LITT tissue distortion.
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
- •Subjects must have suspected high grade glioma by MRI
- •Subjects must have received no prior therapies for this disease.
- •Patients must be considered appropriate candidates for LITT.
- •Karnofsky Performance status ≥ 60%
- •Subjects must have normal organ and marrow function as defined below. Measures of function must be within 14 days prior to registration.
- •Absolute neutrophil count (ANC) ≥ 1500 cells/mm3, platelets ≥ 100,000 cells/mm3, hemoglobin ≥ 10.0 g/dl. Use of transfusion or other intervention to achieve this hemoglobin level is acceptable.
- •Blood urea nitrogen ≤ 30mg/dl and creatinine ≤ 1.7 mg/dl
- •Bilirubin ≤ 2.0 mg/dl, Aspartate aminotransferase/ Alanine aminotransferase (AST/ALT) ≤ 3x upper limit of normal
- •Electrocardiogram without evidence of acute cardiac ischemia
- •Prothrombin time/international normalized ratio (PT INR) <1.4
- •Women of childbearing potential and male participants must practice adequate contraception.
- •For women of childbearing age, negative pregnancy test within 14 days prior to registration
- •Subjects must have the ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Participants not eligible to obtain MRI with and without contrast
- •Recurrent High grade gliomas (HGG)
- •Cerebral edema, grade 3 or greater prior to surgery
- •Post-operative complications including significant neurological decline or hemorrhage that causes a drop in KPS to less than 60 or renders the patient not suitable for chemoradiation as determined by their treating physician
- •Severe co-morbidity that would confer excess risk of surgery, radiation or chemotherapy, as determined by the treating physician.
- •Any other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration of completion of protocol therapy
- •Any other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy.
- •Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
- •Participants receiving other investigational agents.
研究组 & 干预措施
LITT with Radiation and Temozolomide
Laser interstitial thermal therapy (LITT) followed by Radiation therapy, three-dimensional conformal radiotherapy (3D-CRT) or intensity modulation radiation therapy (IMRT), 60 Gy/30 fractions. Radiation given with chemotherapy Temozolomide
干预措施: LITT (Procedure)
LITT with Radiation and Temozolomide
Laser interstitial thermal therapy (LITT) followed by Radiation therapy, three-dimensional conformal radiotherapy (3D-CRT) or intensity modulation radiation therapy (IMRT), 60 Gy/30 fractions. Radiation given with chemotherapy Temozolomide
干预措施: Temozolomide (Drug)
LITT with Radiation and Temozolomide
Laser interstitial thermal therapy (LITT) followed by Radiation therapy, three-dimensional conformal radiotherapy (3D-CRT) or intensity modulation radiation therapy (IMRT), 60 Gy/30 fractions. Radiation given with chemotherapy Temozolomide
干预措施: Radiation therapy (Radiation)
结局指标
主要结局
Study safety as determined by the number of patients who experience pre-specified adverse events
时间窗: Up to 12 weeks after LITT therapy
pre-specified adverse events include: Wound dehiscence, grade 3 (CTCAE v4.0), Grade 3 Seizures (CTCAE v4.0) in patients without a prior history of seizures and on adequate anti-seizure medications, Cerebral edema, grade 4 (CTCAE v4.0), Failure to complete of 60 Gy radiation
次要结局
- Number of patients with adjustments to radiation plan to account for post-LITT tissue distortion(Up to 12 weeks after LITT therapy)