Clinical trial · Interventional
Hypofractionated Radiotherapy Plus Temozolamide in Patients Younger Than 70 Years With Glioblastoma
Prospective, Pilot Study to Evaluate Hypofractionated Radiotherapy Associated With Temozolomide in Patients Aged 18 to 70 Years With Glioblastoma (HypoGBM)
NCT07492836CI-TRIAL-00106466HipoGBMnot yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is to evaluate the feasibility, safety and effectiveness of radiotherapy with fewer days of treatment and a higher dose of radiation each day in patients under 70 years of age diagnosed with a brain tumor known as glioblastoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma (GBM) | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypofractionated Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arm
- description
- Hypofractonated Radiotherapy
- interventionNames
- Radiation: Hypofractionated Radiation Therapy
Primary outcomes (2)
- measure
- Feasibility of accrual and planning
- timeFrame
- From enrollment to the end of planning of the 10 patients at 5 months
- description
- Accrual of patients, timely and adequated planning of radiotherapy
- measure
- Incidence of acute and late neurological toxicity
- timeFrame
- Weekly evaluation during treatment and at 4, 12, 24, 36 weeks in the first year and every 6 months until 3 years after radiotherapy.
- description
- Incidence of headache, brain edema and brain radionecrosis will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Initial histological diagnosis of glioblastoma * Age \> 18 and \< 70 years; * Karnofsky Performance Status \> 70%; * Patient consent to participate in the study. Exclusion Criteria: * Patients submitted to any type of previous radiotherapy in the cranial region; * Multicentric tumors; * Contraindication to chemotherapy with temozolomide; * Contraindications for performing magnetic resonance imaging (MRI), such as the use of implants or metallic prostheses; * Pregnant women or women of childbearing age who refuse to undergo the beta-HCG test before treatment and contraception during the intervention.
References
Publications (3)
- BACKGROUNDMuller Bark J, Kulasinghe A, Hartel G, Leo P, Warkiani ME, Jeffree RL, Chua B, Day BW, Punyadeera C. Isolation of Circulating Tumour Cells in Patients With Glioblastoma Using Spiral Microfluidic Technology - A Pilot Study. Front Oncol. 2021 Jun 3;11:681130. doi: 10.3389/fonc.2021.681130. eCollection 2021. PMID 34150645
- BACKGROUNDMallick S, Gupta S, Amariyil A, Kunhiparambath H, Laviraj MA, Sharma S, Sagiraju HKR, Julka PK, Sharma D, Rath GK. Hypo-fractionated accelerated radiotherapy with concurrent and maintenance temozolomide in newly diagnosed glioblastoma: updated results from phase II HART-GBM trial. J Neurooncol. 2023 Aug;164(1):141-146. doi: 10.1007/s11060-023-04391-7. Epub 2023 Jul 15. PMID 37452916
- BACKGROUNDJastaniyah N, Murtha A, Pervez N, Le D, Roa W, Patel S, Mackenzie M, Fulton D, Field C, Ghosh S, Fallone G, Abdulkarim B. Phase I study of hypofractionated intensity modulated radiation therapy with concurrent and adjuvant temozolomide in patients with glioblastoma multiforme. Radiat Oncol. 2013 Feb 20;8:38. doi: 10.1186/1748-717X-8-38. PMID 23425509