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New treatment option for Astrocytoma
Official title Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma
ClinicalTrials.gov ID: NCT06344130
What this study is testing
- What it's testing
- Background: Glioblastoma (GBM) is a cancer of the brain. Current survival rates for people with GBM are poor; survival ranges from 5.2 months to 39 months.
- Phase 1: an early, usually small safety study
- Time commitment: about 3 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 120
You may be able to join if
- Histologic diagnosis of primary glioblastoma or gliosarcoma of the brain, or secondary glioblastoma of the brain due to transformation from a lower...
- Age \>= 18.
- KPS \>= 70%.
- Previous tumor irradiation to curative-intent doses.
- Radiation dose constraints must be achievable based on assessment with MRI and treatment planning CT.
You likely can't join if
- Recent systemic therapy prior to the initiation of the study therapy as follows:
- Bevacizumab used for reasons other than tumor progression or symptomatic management within 2 weeks.
- Temozolomide within 2 weeks.
- Cytotoxic chemotherapy within 3 weeks.
- Any investigational agents within 2 weeks.
- Participants who are unable to undergo MRI evaluation or receive gadolinium contrast for any reason.
See the full eligibility criteria
- Histologic diagnosis of primary glioblastoma or gliosarcoma of the brain, or secondary glioblastoma of the brain due to transformation from a lower grade to a grade 4 tumor.
- Age \>= 18.
- KPS \>= 70%.
- Previous tumor irradiation to curative-intent doses.
- Radiation dose constraints must be achievable based on assessment with MRI and treatment planning CT.
- Participants must have adequate organ and marrow function as defined below:
- Absolute neutrophil count (ANC) \>= 1,000/microL
- Platelets \>= 100,000/microL
- Individuals of child-bearing potential (IOCBP) and individuals who can father children must agree to use effective contraception (barrier, hormonal, intrauterine device, surgical sterilization, abstinence) from study...
- Nursing participants must be willing to discontinue nursing from study treatment initiation through 6 months after the last study treatment.
- The ability of a participant to understand and the willingness to sign a written informed consent document.
- Recent systemic therapy prior to the initiation of the study therapy as follows:
- Bevacizumab used for reasons other than tumor progression or symptomatic management within 2 weeks.
- Temozolomide within 2 weeks.
- Cytotoxic chemotherapy within 3 weeks.
- Any investigational agents within 2 weeks.
- Participants who are unable to undergo MRI evaluation or receive gadolinium contrast for any reason.
- Any prior therapy after surgical re-resection or biopsy within 2 weeks prior to the initiation of the study therapy.
- Requiring radiation therapy within 12 months prior to the initiation of study therapy.
- History of prior therapy with Novacure TTF, Gliadel wafers, or GammaTile therapy.
- Positive beta-human chorionic gonadotropin (HCG) pregnancy test performed in individuals of childbearing potential at screening.
- Participants with known or suspected radiation sensitivity syndromes.
- Uncontrolled intercurrent illness evaluated by medical history and physical exam that are not stable and would potentially increase the risk to the participant.
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.