Targeting the Renin-Angiotensin System in Glioblastoma (TRAS-GB) Trial

Phase 2

Not yet recruiting

• Conditions: Glioblastoma; Cancer - Brain

• Registration Number: ACTRN12622001201763
• Lead Sponsor: Gillies McIndoe Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-07
• Last Update Posted: 12 September 2022

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Patients with histologically confirmed glioblastoma who have completed surgery (biopsy or debulking) and chemoradiotherapy or who have had radiotherapy alone, and have a good performance status with a Karnofsky score of at least 60.
Note the chemotherapy treatment is temozolomide (TMZ).

Exclusion Criteria

1.Are unable to provide informed consent
2.Are unable to swallow tablets and capsules
3.Have persistent platelet count of less than 100/µL
4.Have not completed surgery and first cycle of TMZ concomitant with radiotherapy
5.Require on-going treatment with medications that increase renin levels, such as calcium channel blockers and diuretics
6.Are not motivated including those who are non-adherent, e.g., abuse alcohol
7.Less than 16 years
8.Older than 80 years
9.On other studies or trials
10.Have contraindications to any of the study treatments including asthma, systolic blood pressure (BP) less than or equal to 100mmHg, allergies to the trial medications, medications that interfere with the proposed treatments
11.Have significant immune compromise including HIV infection, organ transplant patients on immunosuppression, chronic lymphocytic leukaemia
12.Breastfeeding, pregnant or plan to be pregnant
13.Have terminal organ failure:
a. Moderate or severe renal impairment (GFR less than 60mL/min)
b. Liver disease
c. Congestive heart failure/myocardial infarction within the last 6 months.
d. Cerebrovascular disease (CVA/TIA/hemiplegia, except mild dementia).
e. Moderate or severe peripheral vascular disease.
14.Have a second cancer that is expected to impact on the results of this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall median survival from diagnosis[Assessed on an ongoing basis for study duration. The study is planned for a 4 year duration.]

Secondary Outcome Measures

Name	Time	Method
Survival after initiation of trial treatment regime<br><br>[Assessed on an ongoing basis for study duration. The study is planned for a 4 year duration.];Rate of radiological tumour progression. This is assessed by serial FET PET scans.[5 weeks post-commencement of trial medications (baseline), and then 4, 9, 18 and 36 months after final TMZ dose];Change in quality of life (QoL) assessed by EORTC QLQ-30 and QLQ-BN20[Baseline, and then 6, 4, 9, 18 and 36 months after final TMZ dose];Change in performance status assessed by Karnofsky performance score[Baseline, and then 6, 4, 9, 18 and 36 months after final TMZ dose]