Preoperative Preradiotherapy TTFields (PORTRAIT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- To determine the incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of Pre-Operative and Pre-Radiotherapy TTFields additional to the standard treatment of care (SoC) including adjuvant TTFields.
研究概览
简要总结
PreOperative PreRAdIotherapy Tumour Treating Fields (PORTRAIT) is a Phase I study that will test the safety and feasibility of Optune administered preoperatively and preradiotherapy in patients with a new radiological diagnosis of glioblastoma (GBM). Participants will be required to undergo additional MRI sequencing scans and provide blood, tear fluid and tissue samples over a maximum of 6 months. After the study patients will follow their standard treatment pathway.
详细描述
Glioblastoma is the most common primary malignant brain tumour in adults. Its outcomes are poor due to local disease progression in most patients. Current treatment includes surgery followed by chemotherapy and radiotherapy 4-6 weeks after surgery. In this time interval, some tumour cells do not receive any treatment. Furthermore, studies show that around half of all glioblastoma patients experience rapid early progression (REP) i.e. growth of the tumour in the time interval between surgery and postoperative chemotherapy/radiotherapy. REP is associated with a shorter survival and there are currently no effective treatments or preventative measures to address it.
Tumour Treating Fields (TTFields), also known as Optune, is a locally applied treatment modality that has contributed to a better survival outcome for glioblastoma patients when used after surgery and chemo-radiotherapy. The investigators hypothesize that earlier treatment using the Optune device before the surgery and between the surgery and postoperative radiotherapy can prevent REP and improve patient outcome. The PORTRAIT (PreOpeRaTive pRerAdIotherapy Ttfields) phase 1 trial will test the safety and feasibility of Optune treatment before surgery and before post-operative radiotherapy in a maximum of 14 patients. Participants will be required to undergo additional MRI sequencing scans and provide blood, tear fluid and tissue samples over a maximum of 6 months.
A non-experimental arm (Non-EA) of 28 patients will allow comparisons of data collected from PORTRAIT experimental arm patients with comparable Standard of Care (SoC) treated patients from the same time frame. This will maximise PORTRAIT's translational and clinically relevant components.
Participants will be invited to the research study if they are over the age of 35 and have a new radiological diagnosis of glioblastoma. All recruitment and treatment will be conducted at the Christie NHS Foundation Trust and Northern Care Alliance NHS Foundation Trust.
The study is funded by a research grant from Novocure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is aged >35 years (age range of more likely to suffer from an IDHwt World Health Organisation (WHO) grade 4 astrocytoma)*
- •Patient is male or female.
- •Patient has a new radiological diagnosis of glioblastoma.
- •Patient has a performance status judged by WHO, Eastern Cooperative Oncology Group (ECOG) score = 0-
- •Patient has been reviewed by Neuro-oncology multidisciplinary team (MDT - neurosurgeon, clinical oncologist, radiologist and pathologist); MDT consensus that offering study entry is clinically appropriate and safe i.e. patient unlikely to come to harm (e.g. hydrocephalus) from delayed surgery and pre-operative Optune based on available clinical information and imaging.
- •PI has confirmed at the first clinic visit that study entry is clinically appropriate and safe (e.g. lack of severe and debilitating symptoms of raised intracranial pressure).
- •There is intention to treat the patient with surgical resection and postoperative adjuvant therapy as per current standard of care (40Gy/15 fr or 60Gy/30fr).
- •Patient has adequate haematological and biochemical parameters for surgery and contrast agent administration (full blood count and coagulation profile deemed acceptable by clinical team, eGFR >30ml/min).
- •Patient has mental capacity to consent for treatment.
- •Patient is able and willing to give informed consent
- •Criteria specific to the experimental arm:
- •Patient is able and willing to comply with study protocol requirements to continuously shave their head
- •Patient is able and willing to comply with study protocol requirements to wear Optune equipment for the required duration.
排除标准
- •Patients with uncontrolled seizures.
- •Patients are due to undergo a planned biopsy procedure only.
- •Patients have a suspicion of other tumour on CT body scan or known malignancy except non-melanoma skin cancer, completely resected or prostate cancer (with Prostate Specific Antigen of less than or equal to 0.1 ng/ml) within the past three years.
- •Patients have contraindications to contrast-enhanced MRI scanning (e.g. claustrophobia, gadolinium allergy).
研究组 & 干预措施
Non-Experimental Arm
Patients will follow the routine care pathway for glioblastoma and timings of the following will be determined by the clinical team.
Optune
Patients will apply TTFields (a treatment device referred to as Optune) before surgery and continue using this once the stitches are removed (approximately one to two weeks after surgery). Patients will wear the Optune application for 2 to 3 weeks before their standard-of-care (SoC) surgery and 3 to 4 weeks after the surgery (while awaiting their postoperative radiotherapy). Treatment with TTFields will be delivered through 4 transducer arrays with 9 insulated electrodes each placed on the shaved scalp and connected to a portable device set to generate 200-kHz electric fields within the brain.
干预措施: TTFields (Device)
结局指标
主要结局
To determine the incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of Pre-Operative and Pre-Radiotherapy TTFields additional to the standard treatment of care (SoC) including adjuvant TTFields.
时间窗: 18 months
This endpoint will be tested by skin toxicity / wound complications. Toxicity is defined using CTCAE v5.0 and study related complications are defined as; * Skin toxicity grade 3 or higher * Wound closure or wound healing problems grade 2 or higher that are possibly related to TTFields treatment
次要结局
- Skin reactions(18 month)
- Registration of postoperative surgical complications(18 months)
- Registration of radiotherapy related complications(18 months)
- Overall survival(18 months)
- Concordance between MRI based diagnosis of glioblastoma and definitive histological diagnosis(18 months)
- REP: tumour volume difference between the post-operative MRI and pre-radiotherapy MRI.(18 months)
- Steroid dose after TTFields(18 months)
- Progression free survival(18 months)
- Collection of liquid biopsies(18 months)