Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 14 of 14

List	Outcome	Time frame	Description
Primary	Percentage of Participants With an Objective Response	From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	Objective response is defined as a best overall response of complete response (CR) or partial response (PR), evaluated using modified International Society of Pediatric Oncology Brain, Tumor Subcommittee for the Reporting of Trials criteria. Response was confirmed at least 28 days after the first assessment where the response criteria were met. Response was assessed by magnetic resonance imaging (MRI) every 8 weeks. CR: • Complete disappearance of all enhancing tumor and mass effect • On a stable or decreasing dose of corticosteroids (or receiving only adrenal replacement doses) • Stable or improving neurologic examination sustained for ≥ 4 weeks • If cerebral spinal fluid (CSF) evaluation was positive, it must become negative (confirmed at least 2 times at consecutive samplings). PR: • ≥ 50% reduction in tumor size by bi-dimensional measurement • On a stable or decreasing dose of corticosteroids • Stable or improving neurologic examination sustained for ≥ 4 weeks.
Secondary	Duration of Response	From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	Duration of response (complete or partial response \[CR/PR\]) was defined as the time from the date of the first documented response (CR/PR) to the first documented progression or death due to underlying cancer. If a participant had not progressed or died, the duration of overall response was censored at the date of last adequate disease assessment. Duration of response was only defined for participants whose best overall response was CR or PR. Progression was defined as a worsening of neurologic status that could not be explained by other causes, a \> 25% increase in tumor size, the appearance of new lesions or CSF positivity, or increasing doses of corticosteroids required to maintain stable status.
Secondary	Percentage of Participants With a Minor Response	From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	Participants with a best overall response of minor response (MR), defined as: • ≥ 25% to \< 50% reduction in tumor size by bi-dimensional measurement • On a stable or decreasing dose of corticosteroids • Stable or improving neurologic examination sustained for ≥ 4 weeks.
Secondary	Percentage of Participants With Disease Control	From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	Disease control is a best overall response of CR or PR or MR or Stable disease (SD). CR: • Complete disappearance of all enhancing tumor and mass effect • On a stable or decreasing dose of corticosteroids • Stable or improving neurologic examination sustained for ≥ 4 weeks • If CSF evaluation was positive, it must become negative (confirmed at least 2 times consecutively). PR: • ≥ 50% reduction in tumor size by bi-dimensional measurement • On a stable or decreasing dose of corticosteroids • Stable or improving neurologic examination sustained for ≥ 4 weeks. MR: • ≥ 25% to \< 50% reduction in tumor size by bi-dimensional measurement • On a stable or decreasing dose of corticosteroids • Stable or improving neurologic examination sustained for ≥ 4 weeks. SD: • Neurologic examination is at least stable • Maintenance corticosteroid dose is not increased • MRI meets neither the criteria for minor response nor for progressive disease • Sustained for ≥ 8 weeks.
Secondary	Progression Free Survival (PFS)	From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	Progression-free survival was defined as the time from randomization to disease progression based on central nervous system (CNS)-specific evaluation criteria as assessed by the investigator or death due to any cause, whichever occurs first. Participants did not progress or die before the data cutoff date for analysis were censored at the date of last disease assessment (including both radiologic assessment and neurologic assessment) where non-progression was documented. If a participant received any further anticancer therapy without prior documentation of disease progression, the participant was censored at the date of last disease assessment before starting new anti-cancer treatment. Participants were also censored at the date of last disease assessment with no documented progression if patients discontinued treatment for undocumented progression, toxicity or other reason before the data cutoff date for analysis.
Secondary	Percentage of Participants With Prolonged Stable Disease	From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	Prolonged stable disease (SD) was defined as SD with a duration of at least 16 weeks. The percentage of participants with prolonged SD was defined as participants who achieved a best overall response of CR or PR or MR or SD, and did not progress within 16 weeks from randomization. Progression was defined as a worsening of neurologic status that could not be explained by other causes, a \> 25% increase in tumor size, the appearance of new lesions or CSF positivity, or increasing doses of corticosteroids required to maintain stable status.
Secondary	Duration of Stable Disease	From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	Duration of stable disease (SD; defined as participants with an overall best response of complete, partial or minor response or stable disease) was defined as the time from the date of randomization to the first documented progression or death due to underlying cancer. If a participant had not progressed or died, the duration of SD was censored at the date of last adequate disease assessment. Duration of SD was only defined for participants whose best overall response was CR or PR or MR or SD. Progression was defined as a worsening of neurologic status that could not be explained by other causes, a \> 25% increase in tumor size, the appearance of new lesions or CSF positivity, or increasing doses of corticosteroids required to maintain stable status.
Secondary	Overall Survival (OS)	From randomization up to 12 months after the last dose. Median duration of follow-up was 12.9 months for erlotinib and 14.4 months for etoposide.	Overall survival was defined as the time from the date of randomization until the documented date of death. Participants who were still alive by the data cutoff date for analysis were censored on the last day the participant was known to be alive.
Secondary	Safety Assessed Through Evaluation of Physical Exams, Vital Signs, Clinical Laboratory Tests and Adverse Events (AEs)	From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.	An AE was defined as any untoward medical occurrence in a study participant and did not necessarily have a causal relationship with study treatment. Clinically significant vital sign assessments, findings on physical or neurological examination, and laboratory findings associated with signs and/or symptoms requiring withdrawal, dose modification or medical intervention were recorded as AEs. An AE was considered serious if it resulted in death, a life-threatening situation, inpatient hospitalization or prolongation of an existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a patient who received study drug or other important medical events. The relationship of each AE to study drug was assessed as either related or not related.
Secondary	Area Under the Curve From Time 0 to 24 Hours Post-dose for Erlotinib	Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose.	Pharmacokinetic parameters were determined from the serial plasma concentration data obtained for erlotinib. Area under the plasma concentration-time curve from time zero to 24 hours (the dosing interval) measured at steady state using sparse sampling.
Secondary	Maximum Observed Plasma Concentration of Erlotinib (Cmax)	Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose.	Pharmacokinetic parameters were determined from the serial plasma concentration data obtained for erlotinib. Maximum observed plasma concentration of erlotinib (Cmax) was measured at steady state on Day 14 using sparse sampling.
Secondary	Time to Maximum Observed Plasma Concentration of Erlotinib (Tmax)	Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose.	Pharmacokinetic parameters were determined from the serial plasma concentration data obtained for erlotinib. Time to the maximum observed plasma concentration of erlotinib (Tmax) was measured at steady state on Day 14 using sparse sampling.
Secondary	Apparent Body Clearance (CL/F) of Erlotinib	Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose.	Pharmacokinetic parameters were determined from the serial plasma concentration data obtained for erlotinib. Apparent body clearance (CL/F) of erlotinib was measured at steady state on Day 14 using sparse sampling.
Secondary	Apparent Volume of Distribution (Vz/F) of Erlotinib	Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose.	Pharmacokinetic parameters were determined from the serial plasma concentration data obtained for erlotinib. The apparent volume of distribution (Vz/F) of erlotinib was measured at steady state on Day 14 using sparse sampling.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

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ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

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