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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental | Hypofractonated Radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypofractionated Radiation Therapy | Radiation | 60 Gy in 20 fractions of 3 Gy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of accrual and planning | Accrual of patients, timely and adequated planning of radiotherapy | From enrollment to the end of planning of the 10 patients at 5 months |
| Incidence of acute and late neurological toxicity | Incidence of headache, brain edema and brain radionecrosis will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. | Weekly evaluation during treatment and at 4, 12, 24, 36 weeks in the first year and every 6 months until 3 years after radiotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival and Progression Free Survival | Death from any cause and disease progression during treatment and follow-up time | Start of radiotherapy to the date of event (death or progression of disease) up tp 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Correlative science | Evaluation of circulating tumor cells in the blood | Before and 4 to 6 weeks after radiotherapy |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandre B Cavalcanti, MD PhD | Contact | 55 11 3053 6611 | abiasi@hcor.com.br | |
| Karina L Negrelli, VMD | Contact | 55 11 3053 6611 | knegrelli@hcor.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Douglas G Castro, MD PhD | Hospital do Coracao | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34150645 | Background | 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. | |
| 37452916 | Background |
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All IPD collected throughout the trial,
Beginning 6 months after publication with no end date
A proposal that describes planned analyses must be submitted by a researcher with a history of publishing on the topic
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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Hypofractonated Radiotherapy with 60 Fy in 20 fractions of 3 Gy
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| 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. |
| 23425509 | Background | 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. |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |