Hypofractionated Radiotherapy Plus Temozolamide in Patients Younger Than 70 Years With Glioblastoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hypofractionated Radiation Therapy.
- Who it may be relevant to
- Registry conditions: Glioblastoma (GBM). Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective, Pilot Study to Evaluate Hypofractionated Radiotherapy Associated With Temozolomide in Patients Aged 18 to 70 Years With Glioblastoma (HypoGBM)
Overview
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.
Detailed description
The goal of this clinical trial is to evaluate the feasibility (accrual of patients, planning of radiotherapy), safety (acute and late neurological toxicity) and effectiveness (overall survival and progression free survival) of radiotherapy with fewer days of treatment and a higher dose of radiation each day (dose of 60 Gy in 20 fractions of 3 Gy) in patients between 18 and 70 years of age diagnosed with a brain tumor known as glioblastoma. Additionally, circulating tumor cells will be searched in the blood before and after radiotherapy and its quantitative and qualitative analysis will be correlated with the survival outcomes.
Interventions
- Radiation Hypofractionated Radiation Therapy
60 Gy in 20 fractions of 3 Gy
Primary outcome measures
- Feasibility of accrual and planning [Time frame: From enrollment to the end of planning of the 10 patients at 5 months]
- Incidence of acute and late neurological toxicity [Time frame: Weekly evaluation during treatment and at 4, 12, 24, 36 weeks in the first year and every 6 months until 3 years after radiotherapy.]
Secondary outcome measures (1)
- Overall Survival and Progression Free Survival [Time frame: Start of radiotherapy to the date of event (death or progression of disease) up tp 3 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Muller 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
- Mallick 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
- Jastaniyah 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
Identifiers
NCT: NCT07492836 · 95122526.0.0000.0060