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:
2025-12-24 @ 2:02 PM
Ignite Modification Date:
2025-12-24 @ 2:02 PM
NCT ID:
NCT05608395
Eligibility Criteria:
Inclusion Criteria:
1. The subject is a person with a histologically proven diagnosis of glioblastoma (GB) according to WHO 2016.
2. The subject is male or female, aged 18 years or older.
3. Performance status (PS) according to ECOG (Eastern Cooperative Oncology Group) 0-2.
4. Healed operation wound.
5. Post-operative MR up to 72 hours.
6. Indication to adjuvant chemoradiotherapy.
7. Patient has to express his/her informed consent and sign the form before the screening period.
8. Detected rapid early progression.
9. Patient must achieve following values of laboratory parameters in the peripheral blood during the screening period:
1. neutrophiles (total count) ≥1500/mm3
2. platelets (total count) ≥100 000/mm3
3. hemoglobin ≥ 9,0 g/dL
4. serum creatinin ≤1,5x of upper limit of normal, ULN
5. total bilirubin 1,5x ULN, unless documented Gilbert's syndrome, for which bilirubin ≤ 3x ULN is permitted
6. AST/ALT ≤3x ULN
Exclusion Criteria:
1. Prior brain surgery.
2. Prior radiotherapy targeting brain.
3. The history of active/currently treated cancer (solid tumor); the exceptions are: non-melanoma skin cancer, in situ bladder carcinoma, in situ gastric cancer, in situ colorectal carcinoma, in situ cervical carcinoma, in situ breast cancer.
4. Any systemic disease or health condition that might posses a risk at anticancer therapy and imaging techniques (MRI, MET PET).
5. Patients must not have substance abuse disorders that would interfere with cooperation with the requirements of the trial.
6. Patients must not have any evidence of ongoing (active) infection (HIV, hepatitis A, B, C).
7. Pregnant and/or breastfeeding women.
8. Patient who disagree and refuses to sign an Informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05608395
Study Brief:
Protocol Section:
NCT05608395