Trial NCT06835803
Enhanced Local Intensified Radiation Therapy in Elderly Glioblastoma: A Phase 2 Hybrid Randomized Trial
- Phase
- Phase 2
- Sponsor
- Brigham and Women's Hospital
- Conditions
- Glioblastoma (GBM)
- Ages
- 65+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
Inclusion 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 diagnosisAge
* Adequate functional status as measured by a ECOG Performance Status 0, 1 or 2, at time of enrollment.Performance status
* 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 creatinine ≤ 1.5 times the upper limit of normalRenal Total serum bilirubin ≤ 1.5 times the upper limit of normalHepatic ALT (SGPT) < 2.5 times the upper limit of normal and/or AST (SGOT) < 2.5 times the upper limit of normal
-Patient may have received corticosteroids, but must be on a stable or decreasing dose for at least 14 days prior to randomization.
Exclusion Criteria:
* Participants with recurrent glioma.
* Participants with evidence of spinal, leptomeningeal, or more distant disease.Brain metastases
* 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 population-level data for the specified disease site and stage.Prior malignancy
* 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 receive protocol treatment.
Restrictions found (6)
- AgeOutrightinclusion
age >= 65
Show in the text - Brain metastasesOutrightexclusionShow in the text
- HepaticConditionalinclusion
bilirubin <= 1.5 x ULN
Show in the text - Performance statusConditionalinclusion
ECOG 0-2
Show in the text - Prior malignancyConditionalexclusionShow in the text
- RenalConditionalinclusion
creatinine <= 1.5 x ULN
Show in the text
Recruiting in Massachusetts
- Brigham and Women's Hospital · Boston, Suffolk County
- Dana-Farber Brigham Cancer Center, Milford Hospital · Milford, Worcester County
- Dana-Farber Brigham Cancer Center, South Shore Hospital · South Weymouth, Norfolk County