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New treatment option for Glioblastoma (GBM)
Official title Enhanced Local Intensified Radiation Therapy in Elderly Glioblastoma: A Phase 2 Hybrid Randomized Trial
ClinicalTrials.gov ID: NCT06835803
What this study is testing
- What it's testing
- Glioblastoma (GBM) is an aggressive malignancy of the central nervous system. Older adults with GBM have a unique constellation of medical, psychosocial, and supportive care needs.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 3 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join if
- Histological confirmation of WHO grade 4 glioblastoma (IDH wild-type by immunohistochemistry or sequencing). Histopathology must be confirmed by...
- Newly diagnosed disease, with time elapsed from diagnostic surgery/resection \<8 weeks.
- Age ≥ 65 years old at time of glioblastoma diagnosis
- Adequate functional status as measured by a ECOG Performance Status 0, 1 or 2, at time of enrollment.
- Adequate hematological, renal and hepatic functions as defined by the following required laboratory values obtained within 45 days prior to...
You likely can't join if
- Participants with recurrent glioma.
- Participants with evidence of spinal, leptomeningeal, or more distant disease.
- Participants with another active central nervous system malignancies requiring treatment.
- Participants with a second invasive malignancy that is A) incompletely treated or requiring ongoing treatment, or B) reasonably anticipated to be...
- Participants with any other major medical illnesses or psychiatric treatments that in the treating physician's opinion will prevent administration or...
- Participants with inadequate mental capacity to provide informed consent
See the full eligibility criteria
- Histological confirmation of WHO grade 4 glioblastoma (IDH wild-type by immunohistochemistry or sequencing). Histopathology must be confirmed by central review.
- Newly diagnosed disease, with time elapsed from diagnostic surgery/resection \<8 weeks.
- Age ≥ 65 years old at time of glioblastoma diagnosis
- Adequate functional status as measured by a ECOG Performance Status 0, 1 or 2, at time of enrollment.
- Adequate hematological, renal and hepatic functions as defined by the following required laboratory values obtained within 45 days prior to randomization: Platelet count ≥ 100 x 10\^9/L (100,000 cells/mm\^3) Serum...
- Participants with recurrent glioma.
- Participants with evidence of spinal, leptomeningeal, or more distant disease.
- Participants with another active central nervous system malignancies requiring treatment.
- Participants with a second invasive malignancy that is A) incompletely treated or requiring ongoing treatment, or B) reasonably anticipated to be associated with a median overall survival of less than 1 year based on...
- Participants with any other major medical illnesses or psychiatric treatments that in the treating physician's opinion will prevent administration or completion of protocol therapy.
- Participants with inadequate mental capacity to provide informed consent
- Participants who cannot receive gadolinium
- Participants who have undergone prior head and neck or cranial radiation or radiation to any other site previously that would be reasonably anticipated to result in a significant overlap in radiation fields.
- Participants who have received systemic or radiosensitizing therapy for a prior head and neck or central nervous system malignancy or any investigational cancer drug for glioblastoma prior to randomization.
- Participants who have received or plan to receive any other form of non-surgical local or field treatment overlapping with the anticipated radiation field.
- Patients with a serious active infection (such as a wound infection requiring parenteral antibiotics) or other acute medical conditions at the time of randomization that would impair the ability of the patient to...
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Milford, Massachusetts, United States
- South Weymouth, Massachusetts, 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 weeks 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, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; Milford, Massachusetts, United States; South Weymouth, Massachusetts, 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.