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 @ 5:47 PM
Ignite Modification Date:
2025-12-24 @ 5:47 PM
NCT ID:
NCT01310868
Eligibility Criteria:
INCLUSION CRITERIA
i. The patient is reviewed at a specialist neuro-oncology multi-disciplinary team (MDT).
ii. Stealth MRI (neuronavigation) will be performed prior to surgery.
iii. Imaging is evaluated by a neuro-radiologist and judged to have typical appearances of a primary GBM
iv. Radical resection is judged to be realistic by the neurosurgeons at the MDT (i.e. NICE criteria for the use of Carmustine wafers can be met)
v. WHO performance status 0 or 1
vi. Age ≥18
vii. Patient judged by MDT to be fit for standard radical aggressive therapy for GBM (resection followed by RT with concomitant and adjuvant temozolomide)
EXCLUSION CRITERIA
i. GBM thought to be transformed low grade or secondary disease
ii. The patient has not been seen by a specialist MDT.
iii. There is uncertainty about the radiological diagnosis
iv. 5-ALA or Carmustine wafers is contra-indicated (inc known or suspected allergies to 5-ALA or porphyrins, or acute or chronic types of porphyria)
v. Pregnant or lactating women
vi. Known or suspected HIV or other significant infection or comorbidity that would preclude radical aggressive therapy for GBM
vii. Active liver disease (ALT or AST ≥5 x ULRR)
viii. Concomitant anti-cancer therapy except steroids
ix. History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within 5 years
x. Previous brain surgery (including biopsy) or cranial radiotherapy
xi. Platelets \<100 x109/L
xii. Mini mental status score \<15
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01310868
Study Brief:
Protocol Section:
NCT01310868