Trial · NCT00084838

Chemotherapy Combined With Radiation Therapy for Newly Diagnosed CNS AT/RT

NCT00084838, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2015-12-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Chemotherapy Combined With Radiation Therapy for Newly Diagnosed CNS AT/RT. Trials, record NCT00084838. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00084838

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Chemotherapy Combined With Radiation Therapy for Newly Diagnosed CNS AT/RT
NCT number: NCT00084838
Status: Completed
Phases: Phase 2
Enrollment: 25 participants, actual
Lead sponsor: Dana-Farber Cancer Institute
Conditions: Central Nervous System Tumor, Pediatric
Interventions: filgrastim, cisplatin, cyclophosphamide, cytarabine, dexrazoxane hydrochloride, doxorubicin hydrochloride, etoposide, leucovorin calcium, methotrexate, temozolomide, therapeutic hydrocortisone, vincristine sulfate, radiation therapy, Dactinomycin
First posted: 2004-06-11
Last updated: 2015-12-24
Results first posted: 2015-12-24
Limitations and caveats: None. Trial was completed.

Source ClinicalTrials.gov

Registered outcomes19

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

List	Outcome	Time frame	Description
Primary	2-yr Overall Survival	Patients are followed for survival up to 5 yrs post-therapy completion or death; As of this analysis, median follow-up among survivors was 31 months with the longest follow-up being 40 months.	Overall survival is defined as the time from date of diagnosis to death or date of last follow-up. 2-year overall survival is the probability of patients remaining alive at 2-years from study entry estimated using Kaplan-Meier (KM) methods which censors patients at date of last follow-up. Precision of this conditional probability estimate was measured in terms of standard error. Median OS, the original primary endpoint, was not estimable based on the Kaplan-Meier method because of insufficient follow-up.
Secondary	Pre-Radiation Therapy Chemotherapeutic Response	Assessed at study entry and pre-RT/post-CT at week 7.	Response pre-RT/post-CT was defined as follows with overall response defined as achieving PR or CR. Complete Response (CR): Complete resolution of all initially demonstrable tumor on MRI or CT evaluation w/o appearance of any new areas of disease; negative CSF cytology. Partial Response (PR): \>/= 50% decrease in the sum of the products of the maximum perpendicular diameters of the tumor (sum LD) relative to baseline w/o appearance of any new areas of disease; CSF cytology unchanged from that at diagnosis or clearing after being initially positive Stable Disease (SD): \<50% decrease in the sum LD w/o appearance of any new areas of disease; CSF cytology unchanged from that at diagnosis or clearing after being initially positive Progressive Disease (PD): \>/= 25% increase in the sum LD relative to baseline, or the appearance of any new areas of disease or appearance of positive cytology after two consecutive negative samples.
Other	Grade 3/4 Events	Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.	All Grade 3-4 events based on CTCAEv2 as reported on case report forms.
Other	Grade 3-4 Auditory/Hearing Events	Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.	All Grade 3-4 Auditory/Hearing events based on CTCAEv2 as reported on case report forms.
Other	Grade 3-4 Blood/Bone Marrow Events	Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.	All Grade 3-4 Blood/Bone Marrow events based on CTCAEv2 as reported on case report forms. Arm Name
Other	Grade 3-4 Gastrointestinal Events	Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.	All Grade 3-4 Gastrointestinal events based on CTCAEv2 as reported on case report forms.
Other	Grade 3-4 Metabolic/Laboratory Events	Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.	All Grade 3-4 Metabolic/Laboratory events based on CTCAEv2 as reported on case report forms.
Other	Grade 3-4 Infection/Febrile Neutropenia Events	Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.	All Grade 3-4 Infection/Febrile Neutropenia events based on CTCAEv2 as reported on case report forms.
Other	Grade 3-4 Neurology Events	Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.	All Grade 3-4 Neurology events based on CTCAEv2 as reported on case report forms.
Other	Grade 3-4 Pain Events	Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.	All Grade 3-4 Pain events based on CTCAEv2 as reported on case report forms.

1 to 10 of 19Source ClinicalTrials.gov

See all 19 registered outcomes

Outcomes19

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	2-yr Overall Survival	Patients are followed for survival up to 5 yrs post-therapy completion or death; As of this analysis, median follow-up among survivors was 31 months with the longest follow-up being 40 months.	The analysis dataset is comprised of all eligible and treated patients.	probability	NUMBER
SECONDARY	Pre-Radiation Therapy Chemotherapeutic Response	Assessed at study entry and pre-RT/post-CT at week 7.	The pre-RT CT response evaluable population is defined as patients who completed chemotherapy per protocol.	proportion of evaluable patients	NUMBER
OTHER_PRE_SPECIFIED	Grade 3/4 Events	Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.	The analysis population excludes 1 patient who withdrew before treatment.	adverse events	NUMBER
OTHER_PRE_SPECIFIED	Grade 3-4 Auditory/Hearing Events	Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.	The analysis population excludes 1 patient who withdrew before treatment.	adverse events	NUMBER
OTHER_PRE_SPECIFIED	Grade 3-4 Blood/Bone Marrow Events	Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.	The analysis population excludes 1 patient who withdrew before treatment.	adverse events	NUMBER
OTHER_PRE_SPECIFIED	Grade 3-4 Gastrointestinal Events	Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.	The analysis population excludes 1 patient who withdrew before treatment.	adverse events	NUMBER
OTHER_PRE_SPECIFIED	Grade 3-4 Metabolic/Laboratory Events	Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.	The analysis population excludes 1 patient who withdrew before treatment.	adverse events	NUMBER
OTHER_PRE_SPECIFIED	Grade 3-4 Infection/Febrile Neutropenia Events	Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.	The analysis population excludes 1 patient who withdrew before treatment.	adverse events	NUMBER
OTHER_PRE_SPECIFIED	Grade 3-4 Neurology Events	Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.	The analysis population excludes 1 patient who withdrew before treatment.	adverse events	NUMBER
OTHER_PRE_SPECIFIED	Grade 3-4 Pain Events	Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.	The analysis population excludes 1 patient who withdrew before treatment.	adverse events	NUMBER

1 to 10 of 19Source ClinicalTrials.gov

See all 19 outcomes

Results by group19

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
2-yr Overall Survival	Multi-agent Intrathecal and Systemic CT With RT (Modified IRS	0.70		probability
Pre-Radiation Therapy Chemotherapeutic Response	Multi-agent Intrathecal and Systemic CT With RT (Modified IRS	0.58	90% Confidence Interval 0.32 to 0.82	proportion of evaluable patients
Grade 3/4 Events	Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)	1021		adverse events
Grade 3-4 Auditory/Hearing Events	Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)	8		adverse events
Grade 3-4 Blood/Bone Marrow Events	Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)	564		adverse events
Grade 3-4 Gastrointestinal Events	Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)	139		adverse events
Grade 3-4 Metabolic/Laboratory Events	Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)	128		adverse events
Grade 3-4 Infection/Febrile Neutropenia Events	Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)	49		adverse events
Grade 3-4 Neurology Events	Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)	45		adverse events
Grade 3-4 Pain Events	Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)	31		adverse events

1 to 10 of 19Source ClinicalTrials.gov

See all 19 results by group

Participant flow4

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Multi-agent Intrathecal and Systemic CT With RT (Modified IRS	25
Overall Study	Eligible and Treated	Multi-agent Intrathecal and Systemic CT With RT (Modified IRS	20
Overall Study	COMPLETED	Multi-agent Intrathecal and Systemic CT With RT (Modified IRS	12
Overall Study	NOT COMPLETED	Multi-agent Intrathecal and Systemic CT With RT (Modified IRS	13

Source ClinicalTrials.gov

Adverse events3

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
serious	Sepsis	Infections and infestations	Multi-agent Intrathecal & Systemic CT w/ RT (Modified IRS III)	1	20	1
serious	Radiation recall	Nervous system disorders	Multi-agent Intrathecal & Systemic CT w/ RT (Modified IRS III)	2	20	2
serious	Transverse Myeolitis	Nervous system disorders	Multi-agent Intrathecal & Systemic CT w/ RT (Modified IRS III)	1	20	1

Source ClinicalTrials.gov

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Multi-agent Intrathecal & Systemic CT w/ RT (Modified IRS III)
Total, other adverse events	Multi-agent Intrathecal & Systemic CT w/ RT (Modified IRS III)	0	0
Total, serious adverse events	Multi-agent Intrathecal & Systemic CT w/ RT (Modified IRS III)	4	20

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
19064966	RESULT

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
P30CA006516	Dana-Farber/Harvard Cancer Center	EBERT, BENJAMIN LEVINE	DANA-FARBER CANCER INST	NATIONAL CANCER INSTITUTE	1985 to 2025

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

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

Each source's terms

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)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00084838

GET https://conductscience.org/api/trials/v1/NCT00084838/registered

API reference For AI assistants