Table of contents
- Trial overview
- Who can participate
- What the trial measures
- Trial phases and design
- Treatment comparisons
- Patient-relevant terms
Trial overview
The available trial data describe one interventional study of 4-IODOPHENYLALANINE I-131 in people with glioblastoma.[1] The study is titled as a Phase III comparison of TLX101-Tx plus standard of care versus standard of care alone for patients with recurrent glioblastoma.[1]
The trial status is Authorised, and the planned enrollment is 50 people.[1] The source also names the intervention as 4-L-[131I]iodo-phenylalanine, which is the form listed in the trial record.[1]
Who can participate
The trial is designed for patients with confirmed first recurrence of glioblastoma, meaning the cancer has come back for the first time after earlier treatment.[1] This target group is important because the study is focused on people whose disease has returned and who need new treatment options.[1]
The data do not list detailed inclusion or exclusion rules beyond this disease group.[1]
What the trial measures
The study looks first at safety and dosimetry in an early part of the program.[1] Safety is assessed through dose-limiting side effects, physical examination, vital signs, ECG findings, laboratory tests, and adverse events graded with NCI CTCAE v5.0.[1]
The trial also measures tolerability, which means how manageable the treatment is for patients.[1] Tolerability is checked with quality-of-life questionnaires, called EORTC QLQ-C30 and EORTC-BN20, and with a neurological symptom scale called the NANO scale.[1]
In the randomized part of the study, the main outcome is overall survival, measured from enrollment until death from any cause.[1] This is the clearest way to see whether the treatment helps people live longer.[1]
Trial phases and design
This is a Phase 3 trial, which means it is testing the treatment in a later stage of development and comparing it with standard treatment.[1] The study has more than one part.[1]
- Part 1a: a safety and dosimetry lead-in using BOIN, which is a dose-finding approach used to help choose the best dose.[1]
- Part 1b: a dose expansion cohort, where more patients receive the study treatment so researchers can learn more about safety, tolerability, and the recommended Phase 3 dose.[1]
- Part 2: a randomized study, which means patients are assigned to compare treatment strategies and see whether the study treatment improves outcomes.[1]
The trial aims to determine the maximum tolerated dose and the recommended Phase 3 dose in the early part of the study.[1] These are dose-selection steps that help researchers choose a dose that can be used more safely in the larger comparison part.[1]
Treatment comparisons
The brief summary says the study is testing TLX101-Tx plus lomustine versus lomustine alone, and in some cases TLX101-Tx may be studied as monotherapy based on the early trial data.[1] Monotherapy means treatment with one medicine rather than a combination.[1]
The main question in the randomized part is whether adding 4-IODOPHENYLALANINE I-131 to standard treatment can improve overall survival compared with standard treatment alone.[1] This is the central patient benefit the trial is trying to prove.[1]
Patient-relevant terms
Adverse events are unwanted medical problems that happen during a study, whether or not the treatment caused them.[1] The trial grades these events using a standard scale so researchers can compare how serious they are.[1]
Quality of life questionnaires ask about daily symptoms and how the disease or treatment affects normal life.[1] The study uses these tools because a treatment is not only judged by survival, but also by how people feel during treatment.[1]
Neurological symptoms are problems related to the brain and nervous system, such as changes in movement, thinking, or other brain functions.[1] The NANO scale is used to measure these symptoms in a structured way.[1]
