Comparing standard surveillance imaging to symptom based imaging in glioblastoma

Phase 3

Not yet recruiting

Conditions: Other disorders of brain in diseases classified elsewhere,

Registration Number: CTRI/2025/06/089633

Lead Sponsor: Tata Memorial Centre

Brief Summary: Glioblastoma is the most common and aggressive malignant brain tumor in adults, with a median survival of approximately 15 months despite standard treatment, which includes maximal safe resection followed by chemoradiotherapy with temozolomide. Imaging, especially MRI, plays a key role in diagnosis, treatment planning, and surveillance; however, standardized imaging protocols for post-treatment follow-up remain undefined. Guidelines from major oncology bodies vary, with surveillance intervals ranging from 2 to 6 months. While routine imaging aims to detect early asymptomatic recurrences, emerging evidence questions its survival benefit and highlights concerns about cost, patient anxiety, and potential overtreatment due to misinterpretation of post-treatment changes.

The MAGNOLIA study is a randomized, open-label, Phase III trial comparing standard surveillance imaging to symptom-based imaging for glioblastoma patients post-treatment. Patients will undergo 3-monthly clinical evaluations, with either 6-monthly MRIs (standard arm) or imaging only upon symptom onset (experimental arm). The primary endpoint is 2-year overall survival, with secondary endpoints including progression-free survival, salvage treatment rates, quality of life, and cost-effectiveness.

A total of 240 adult patients with controlled glioblastoma post-standard therapy will be enrolled over 2 years and followed for one additional year. Statistical analysis will use Kaplan-Meier and log-rank tests, with quality of life assessed via EORTC QLQ-C30 and BN20 questionnaires. Ethical oversight, informed consent, and patient confidentiality are prioritized throughout. The study aims to provide evidence-based guidance on imaging strategies, potentially optimizing patient care while reducing unnecessary imaging and associated burdens.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 240

Inclusion Criteria

Age more than equal to 18years Histopathological diagnosis of Glioblastoma.
Disease clinico radiologically controlled at the completion of standard therapy.
KPS more than or equal to 60 Signing informed consent.

Exclusion Criteria

Patients without tissue diagnosis IDH mutant gliomas Patients with lesions indeterminate for recurrence Pediatric patients less than 18 years.
Patients with confirmed recurrence.
Patients unable to be part of their own informed decision making due to cognitive impairment.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint of this study will be the 2 year overall survival	3 years
survival calculated from the date of diagnosis.	3 years

Secondary Outcome Measures

Name	Time	Method
Progression free survival	Rates of salvage treatment

Trial Locations

Locations (1): Tata Memorial Centre
🇮🇳
Mumbai, MAHARASHTRA, India
Tata Memorial Centre
🇮🇳Mumbai, MAHARASHTRA, India
Dr Arpita Sahu
Principal investigator
7049000101
drarpitasahu@gmail.com