A Prospective, Open-label, Single-arm Clinical Study Evaluating Tumor Treating Fields (TTFields) in Combination With Chemotherapy for Recurrent Glioblastom
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- OS6
Study Overview
Brief Summary
the study is a prospective, single-arm, open-label trial, designed to explore the efficacy and safety of Tumor-Treating Fields (TTFields) combined with second-line chemotherapy treatment in recurrent glioblastoma multiforme (GBM) , TTFields is an portable, battery operated device for chronic treatment of patients with recurrent or progressive glioblastoma multiforme (GBM) using alternating electric fields
Detailed Description
PAST CLINICAL EXPERIENCE:
The effect of the electric fields generated by the TTFields has been tested in two Ⅲ phase trials in humans(EF-11&EF-14). The data from these trials suggest TTFields may improve time to disease progression and overall survival of recurrent GBM patients. EF-11 is a randomized, controlled trial, designed to test the efficacy and safety of a new medical device.Although the number of patients in the trials is small, FDA has approved TTFields as a therapy for patients with recurrent GBM.
DESCRIPTION OF THE TRIAL:
Patients with GBM whose disease has recurred or progressed despite standard treatment (Surgery, radiation therapy, Temozolomide treatment) and meet all of the requirements for participation in the study will be included.Before receiving TTFields treatment, the patient can receive surgery again, and TTFields+BPC chemotherapy can be used after surgery; TTFields+BPC chemotherapy can also be used directly without surgery.
During the trial, TTFields treatment is a cycle (treatment course) every four weeks, and patients are required to complete at least one cycle of treatment. Recommended average daily wearing time ≥18 hours, patients will need to return once every month the hospital outpatient clinics where they will be examined by a physician and undergo routine laboratory examinations. These routine visits will continue for as long as the patient's disease is not progressing. After progression, if such occurs, patients will need to return once per month for two more months to the outpatient clinic for similar follow up examinations.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Sign written informed consent prior to any procedure related to the study;
- •Recurrence and pathologically confirmed WHO Grade IV glioblastoma (GBM);
- •The tumor is located in the supratentorial area
- •Age ≥18 years;
- •Received radiotherapy and maintenance treatment with temozolomide;
- •Expected survival time: > 3 months;
- •KPS score ≥60;
- •Ability to comply with the plan;
Exclusion Criteria
- •Other clinical trials are being tried
- •Had major surgery within 4 weeks before the start of the study or had not recovered after the surgery
- •Received radiotherapy within 4 weeks before the study
- •Received chemotherapy within 4 weeks before the study
- •Women during pregnancy;
- •Allergic to hydrogels;
- •There are important implants in the body, such as pacemaker, defibrillator, shunt tube, deep brain stimulator, etc.;
- •Patients with significantly increased intracranial pressure (shifted >5mm in imaging midline, obvious papilloma, nausea, vomiting, and decreased consciousness)
Outcomes
Primary Outcomes
OS6
Time Frame: 6 months
Overall survival at 6 months
Secondary Outcomes
- Overall survival at 12 months (OS12)(12 months)
- security(2 years)
- overall survival OS(refers to the time from enrollment to tumor disease death from various causes)(2 years)
- Progression-free survival PFS(2 years)
Investigators
Yonggao Mou
Director of neurosurgery department
Sun Yat-sen University