Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2025-12-25 @ 12:54 AM
NCT ID:
NCT03480867
Eligibility Criteria:
Inclusion Criteria
* Newly diagnosed (MR image-based) GBM - Must be able to undergo gadolinium-enhanced MRI.
* Must be a candidate for radical surgical resection in the opinion of the neurosurgeon.
* The tumor must measure less than 6 cm in maximum diameter. The tumor diameter will be the greatest diameter as measured on the contrast-enhanced MRI.
* A neurosurgical oncologist, radiation oncologist and neuro-oncologist will assess each patient in advance of enrollment.
* The estimated post-surgical radiation field must be compatible with the proposed radiation scheme - ie, to ensure a safe radiation margin from structures such as the optic apparatus and brain stem.
* The GBM tumor must be located in the supratentorial compartment only (any component involving the brain stem or cerebellum is not allowed)
* Age\>18years
* Karnofsky Performance Status (KPS) 70.
* History and physical examination within 14 days from start of therapy, including documentation of steroid dose.
* Adequate complete blood counts (Absolute neutrophil count (ANC) .:! 1,800. cells/mm3; Platelets.:! 100,000 cells/mm3; Hemoglobin.:! 10.0 g/dl), renal and liver function within 14 days prior to therapy with values\< 3x (upper limit normal) ULN.
* For females of child-bearing potential, negative serum pregnancy test within 14 days prior to therapy and use of contraception.
* Signed consent form.
Exclusion Criteria:
* Tumors within 1 cm from critical structures (brainstem, optic apparatus), or with massive edema, or with the possibility of herniation, or any tumor that in the neurosurgeon's opinion would be considered unsafe to delay surgery or is not grossly resectable.
* Prior invasive malignancy (except for non-melanomatous skin cancer, non- invasive bladder cancer, and non-invasive cervix cancer) unless disease free for 2:5 years.
* Recurrent or multifocal GBM.
* Any site of metastatic disease (drop metastases).
* Prior chemotherapy or radiation therapy to the head or neck (except for T1 glottic tumor
* Severe active co-morbid medical condition as assessed by medical team.
* Patients enrolled in any other protocol.
* Inability to undergo MRI.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03480867
Study Brief:
Protocol Section:
NCT03480867