PET-guided short-course higher-dose radiotherapy with temozolomide for poor-prognosis glioblastoma
Official title: BIOlogically-guided Short-course HypOfractionatedRadiation Therapy in Poor-prognosis GBM (BIO-SHORT): A Prospective Phase 2 Randomised Control Trial
Run by Tata Memorial Centre · NCT07338539 · Data updated 2026-11-12
This trial will try a shorter, higher-dose PET-guided radiotherapy schedule plus temozolomide in people aged 50 and older with poor-prognosis, IDH‑wildtype glioblastoma who are not candidates for surgery to see if it helps them live longer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 50 Years and up |
| Sex | All |
| Enrollment | 108 (estimated) |
| Sponsor | Tata Memorial Centre Academic / other |
| Drugs / interventions | Bevacizumab, chemotherapy, Radiation |
| Locations | 1 site (Mumbai, Maharashtra) |
| Status | Recruiting |
| Started | November 6, 2025 |
| Main results expected | October 27, 2031 |
| Study ends | October 27, 2031 |
| Registry record updated | May 18, 2026 |
| Trial ID | NCT07338539 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 50 or older with biopsy-proven or imaging-defined IDH‑wildtype glioblastoma who are unfit for surgery, have a Neurological Predictor Scale (NPS) of 2–3, a Karnofsky Performance Status of at least 50, and no prior systemic glioma therapy.
✕Probably not a fit
Patients with IDH‑mutant or histone‑altered gliomas, multifocal or disseminated disease requiring whole‑brain radiation, very poor performance (KPS <50) or NPS scores of 0–1 or 4, prior systemic glioma therapy, or inability to attend the Mumbai treatment site are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized phase 2 trial will enroll 116 patients with biopsy-proven or imaging-defined IDH‑wildtype glioblastoma who are unfit for surgery. Participants will be randomized to standard hypofractionated radiotherapy with temozolomide or to a shorter (1–2 week), higher-dose hypofractionated radiotherapy plan that is guided by PET imaging plus temozolomide, with PET used to identify the most metabolically active tumor regions for focused dosing. The trial will track overall survival, safety, treatment tolerance, and effects on healthy brain tissue. Follow-up includes serial imaging, clinical exams, and standardized performance scales.
Why it matters
Potential benefit: If successful, the approach could extend survival while shortening treatment time and limiting damage to healthy brain tissue by focusing higher doses on the most active tumor areas.
How similar studies have gone: Short-course hypofractionated radiotherapy with temozolomide has shown comparable survival to longer schedules in elderly and poor‑prognosis patients, but PET‑guided focal dose escalation is a newer strategy with limited prior evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with biopsy proven IDH- wild type GBM or imaging defined GBM * Neurological Predictor Scale (NPS) = 2-3 * Unfit for surgery and referred for direct RT * Age \>/= 50 years Exclusion Criteria: * IDH mutant glioma * Histone altered glioma * Multifocal disease or Gliomatosis like appearance which necessitates whole brain RT * Disseminated disease in brain or spine * NPS = 0-1 or = 4 * Karnofsky Performance Status score less than 50(Patient requires considerable assistance and frequent medical care) * Prior administration of any systemic therapy directed against glioma (eg.Temozolomide, CCNU, Bevacizumab)
Where it's running
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Tata Memorial Hospital
Mumbai, Maharashtra, India Recruiting
Study contacts
- Study coordinator: Abhishek Chatterjee, MD
- Email: chatterji08@gmail.com
- Phone: 2224177000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.