Astrocytoma study: Radiation Therapy
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
- This study aims to find a safe way to use radiation again for brain tumors that have returned after initial treatment.
- Who it's for
- The study is looking for adults aged 18 and older who have a specific type of brain cancer called glioblastoma that has come back after radiation.
- What's involved
- Participants will wear a plastic mask for scans to plan their treatment, then receive radiation four times a week for one to three weeks. They will also have blood tests, health questionnaires, and regular check-ups.
- Time commitment
- The study involves weekly radiation for up to three weeks, followed by clinic visits for up to three years and phone or email check-ins for two more years.
- 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
- 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.
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.
- 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.
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Bethesda, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.