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 @ 2:18 AM
Ignite Modification Date:
2025-12-25 @ 2:18 AM
NCT ID:
NCT02097134
Eligibility Criteria:
Inclusion Criteria:
* Newly diagnosed patients with unilateral group D retinoblastoma
* Magnetic resonance imaging (MRI) (or computed tomography \[CT\] if MRI is not available) of the brain must be performed within 14 days prior to study entry
* Diagnostic examination under anesthesia (EUA) must be performed within 14 days prior to study entry
* Rapid central review confirmation of group D disease based on RetCam images from diagnostic EUA must be obtained before starting treatment
* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2
* Patients must have a life expectancy of \>= 8 weeks
* Patients must have adequate renal function, defined as:
* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 or
* A serum creatinine based on age/gender as follows:
* 1 month to \< 6 months: 0.4 mg/dL
* 6 months to \< 1 year: 0.5 mg/dL
* 1 to \< 2 years: 0.6 mg/dL
* 2 to \< 6 years: 0.8 mg/dL
* 6 to \< 10 years: 1 mg/dL
* 10 to \< 13 years: 1.2 mg/dL
* 13 to \< 16 years: 1.5 mg/dL (male); 1.4 mg/dL (female)
* \>= 16 years: 1.7 mg/dL (male); 1.4 mg/dL (female)
* Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age
* Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) \< 2.5 x upper limit of normal (ULN) for age
Exclusion Criteria:
* Patients with bilateral disease
* Unilateral retinoblastoma with group A, B, C, or E eyes
* Prior chemotherapy or radiation therapy for this disease (laser and cryotherapy are allowed and are not considered exclusion criteria)
* Clinical or neuroimaging evidence of extraocular disease or orbital optic nerve involvement
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Study:
NCT02097134
Study Brief:
Protocol Section:
NCT02097134