Trial Outcomes & Findings for Concurrent Carboplatin and Reduced Dose Craniospinal Radiation for Medulloblastoma and Primitive Neuroectodermal Tumor (PNET) (NCT NCT01542736)

NCT ID: NCT01542736

Last Updated: 2022-01-11

Results Overview

MRIs of the head and spine. Number of participants with event free survival at 60 months is reported.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 8 participants
• Primary outcome timeframe: Up to 60 months.
• Results posted on: 2022-01-11

Participant Flow

Participant milestones

Measure	Reduced Radiation With Concurrent Chemotherapy Reduced dose craniospinal radiation with concurrent carboplatin and vincristine administration Carboplatin: Administered concurrently with craniospinal radiation. Vincristine: Administered concurrently with craniospinal radiation. 24 Gy: Craniospinal radiation.
Overall Study STARTED	8
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Reduced Radiation With Concurrent Chemotherapy Reduced dose craniospinal radiation with concurrent carboplatin and vincristine administration Carboplatin: Administered concurrently with craniospinal radiation. Vincristine: Administered concurrently with craniospinal radiation. 24 Gy: Craniospinal radiation.
Overall Study Death	1

Baseline Characteristics

Concurrent Carboplatin and Reduced Dose Craniospinal Radiation for Medulloblastoma and Primitive Neuroectodermal Tumor (PNET)

Baseline characteristics by cohort

Measure	Reduced Radiation With Concurrent Chemotherapy n=8 Participants Reduced dose craniospinal radiation with concurrent carboplatin and vincristine administration Carboplatin: Administered concurrently with craniospinal radiation. Vincristine: Administered concurrently with craniospinal radiation. 24 Gy: Craniospinal radiation.
Age, Categorical <=18 years	7 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	8.125 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 60 months.

MRIs of the head and spine. Number of participants with event free survival at 60 months is reported.

Outcome measures

Measure	Reduced Radiation With Concurrent Chemotherapy n=8 Participants Reduced dose craniospinal radiation with concurrent carboplatin and vincristine administration Carboplatin: Administered concurrently with craniospinal radiation. Vincristine: Administered concurrently with craniospinal radiation. 24 Gy: Craniospinal radiation.
Event-free Survival	7 Participants

PRIMARY outcome

Timeframe: up to 5 years

Overall Survival will be measured at the end of study. number of surviving participants is reported.

Outcome measures

Measure	Reduced Radiation With Concurrent Chemotherapy n=8 Participants Reduced dose craniospinal radiation with concurrent carboplatin and vincristine administration Carboplatin: Administered concurrently with craniospinal radiation. Vincristine: Administered concurrently with craniospinal radiation. 24 Gy: Craniospinal radiation.
Overall Survival	7 Participants

PRIMARY outcome

Timeframe: Week 8

Population: Not all participants were feeling well enough to complete testing at this timepoint.

Neuropsychological testing will be performed after radiation in completed. The Wechsler Intelligence Scale for Children, 5th edition (WISC-V) measures intellectual competence in Verbal Comprehension, Visual Spatial, Fluid Reasoning, Working Memory, and Processing Speed. The average score for the scale is fixed at 100, with a standard deviation of 15. Higher scores indicate higher levels of intellectual competence and a better outcome.

Outcome measures

Measure	Reduced Radiation With Concurrent Chemotherapy n=5 Participants Reduced dose craniospinal radiation with concurrent carboplatin and vincristine administration Carboplatin: Administered concurrently with craniospinal radiation. Vincristine: Administered concurrently with craniospinal radiation. 24 Gy: Craniospinal radiation.
Intellectual Competence Measured by IQ Score: Week 8	102.4 score on a scale Interval 84.0 to 122.0

PRIMARY outcome

Timeframe: Month 24

Population: Not all participants were feeling well enough to complete testing at this timepoint.

Neuropsychological testing will be performed after radiation in completed. IQ score is reported. The Wechsler Intelligence Scale for Children, 5th edition (WISC-V) measures intellectual competence in Verbal Comprehension, Visual Spatial, Fluid Reasoning, Working Memory, and Processing Speed. The average score for the scale is fixed at 100, with a standard deviation of 15. Higher scores indicate higher levels of intellectual competence and a better outcome.

Outcome measures

Measure	Reduced Radiation With Concurrent Chemotherapy n=6 Participants Reduced dose craniospinal radiation with concurrent carboplatin and vincristine administration Carboplatin: Administered concurrently with craniospinal radiation. Vincristine: Administered concurrently with craniospinal radiation. 24 Gy: Craniospinal radiation.
Intellectual Competence Measured by IQ Score: Month 24	96.83 score on a scale Interval 80.0 to 127.0

PRIMARY outcome

Timeframe: Month 60

Population: Not all participants were feeling well enough to complete testing at this timepoint.

Neuropsychological testing will be performed after radiation in completed. IQ score is reported. The Wechsler Intelligence Scale for Children, 5th edition (WISC-V) measures intellectual competence in Verbal Comprehension, Visual Spatial, Fluid Reasoning, Working Memory, and Processing Speed. The average score for the scale is fixed at 100, with a standard deviation of 15. Higher scores indicate higher levels of intellectual competence and a better outcome.

Outcome measures

Measure	Reduced Radiation With Concurrent Chemotherapy n=2 Participants Reduced dose craniospinal radiation with concurrent carboplatin and vincristine administration Carboplatin: Administered concurrently with craniospinal radiation. Vincristine: Administered concurrently with craniospinal radiation. 24 Gy: Craniospinal radiation.
Intellectual Competence Measured by IQ Score: Month 60	79 score on a scale Interval 75.0 to 83.0

Adverse Events

Reduced Radiation With Concurrent Chemotherapy

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Measure	Reduced Radiation With Concurrent Chemotherapy n=8 participants at risk Reduced dose craniospinal radiation with concurrent carboplatin and vincristine administration Carboplatin: Administered concurrently with craniospinal radiation. Vincristine: Administered concurrently with craniospinal radiation. 24 Gy: Craniospinal radiation.
Infections and infestations Death due to multi-system organ failure	12.5% 1/8 • Number of events 1 • Until time of death or progression (Up to 10 years)

Other adverse events

Measure	Reduced Radiation With Concurrent Chemotherapy n=8 participants at risk Reduced dose craniospinal radiation with concurrent carboplatin and vincristine administration Carboplatin: Administered concurrently with craniospinal radiation. Vincristine: Administered concurrently with craniospinal radiation. 24 Gy: Craniospinal radiation.
Nervous system disorders Relapse	12.5% 1/8 • Number of events 1 • Until time of death or progression (Up to 10 years)

Additional Information

Jennifer Raybin, PhD

University of Colorado Denver

Phone: 3037241111

Email: clinicalresearchsupportcenter@ucdenver.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place