Trial · NCT01118377

A Study of Capecitabine (Xeloda®) and Concomitant Radiation Therapy in Children With Newly Diagnosed Brainstem Gliomas

NCT01118377, Phase 2, Completed, Hoffmann-La Roche; results first posted 2013-12-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of Capecitabine (Xeloda®) and Concomitant Radiation Therapy in Children With Newly Diagnosed Brainstem Gliomas. Trials, record NCT01118377. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01118377

On this page

Trial

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

Title: A Study of Capecitabine (Xeloda®) and Concomitant Radiation Therapy in Children With Newly Diagnosed Brainstem Gliomas
NCT number: NCT01118377
Status: Completed
Phases: Phase 2
Enrollment: 45 participants, actual
Lead sponsor: Hoffmann-La Roche
Conditions: Brainstem Glioma
Interventions: Capecitabine, Radiation therapy
First posted: 2010-05-06
Last updated: 2014-02-06
Results first posted: 2013-12-03

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Progression-free Survival	Baseline to the end of the study (up to 20 weeks)	Progression-free survival was defined as the time from the initiation of treatment to the earliest date of failure (disease progression, death from any cause, or a second malignancy) or to the last assessment date for patients who did not fail. Disease progression was defined as progressive neurologic abnormalities or worsening neurologic status not explained by causes unrelated to tumor progression (eg, anticonvulsant or corticosteroid toxicity, electrolyte disturbances, sepsis, hyperglycemia, weaning of steroids, radiation necrosis, etc); or a greater than 25% increase in the bi-dimensional measurement of the tumor, as compared with the previous scan; or the appearance of a new lesion; or an increase in the doses of dexamethasone required to maintain stable neurologic status or imaging.
Secondary	Overall Survival	Baseline to the end of the study (up to 20 weeks)	Overall survival was defined as the time from the initiation of therapy to the date of death from any cause or to the date the patient was last known to be alive for surviving patients.
Secondary	Percentage of Participants With a Tumor Response	Baseline to the end of the study (up to 20 weeks)	Tumor response was defined as either a complete response or a partial response prior to failure (disease progression, death from any cause, or a second malignancy). A complete response was defined as the complete disappearance on magnetic response imaging of all enhancing tumor and mass effect on a stable or decreasing dose of dexamethasone (or only receiving adrenal replacement doses) accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks. A partial response was defined as a greater than or equal to 50% reduction in tumor size by bi-dimensional measurement on a stable or decreasing dose of dexamethasone accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks.

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression-free Survival	Baseline to the end of the study (up to 20 weeks)	Intent-to-treat population: All enrolled participants who received at least 1 dose of capecitabine.	Months	MEDIAN
SECONDARY	Overall Survival	Baseline to the end of the study (up to 20 weeks)	Intent-to-treat population: All enrolled participants who received at least 1 dose of capecitabine.	Months	MEDIAN
SECONDARY	Percentage of Participants With a Tumor Response	Baseline to the end of the study (up to 20 weeks)	Intent-to-treat population: All enrolled participants who received at least 1 dose of capecitabine.	Percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group3

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

Outcome	Group	Value	Spread	Units
Progression-free Survival	Capecitabine + Radiation Therapy	4.9	95% Confidence Interval 4.5 to 6.0	Months
Overall Survival	Capecitabine + Radiation Therapy	10.3	95% Confidence Interval 7.7 to 12.9	Months
Percentage of Participants With a Tumor Response	Capecitabine + Radiation Therapy	2.3	95% Confidence Interval 0.1 to 12.0	Percentage of participants

Source ClinicalTrials.gov

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Capecitabine + Radiation Therapy	45
Overall Study	COMPLETED	Capecitabine + Radiation Therapy	3
Overall Study	NOT COMPLETED	Capecitabine + Radiation Therapy	42

Source ClinicalTrials.gov

Adverse events111

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
other	Alanine aminotransferase increased	Investigations	Capecitabine + Radiation Therapy	33	44
other	Lymphocyte count decreased	Investigations	Capecitabine + Radiation Therapy	32	44
other	White blood cell count decreased	Investigations	Capecitabine + Radiation Therapy	27	44
other	Platelet count decreased	Investigations	Capecitabine + Radiation Therapy	25	44
other	Blood bilirubin increased	Investigations	Capecitabine + Radiation Therapy	14	44
other	Neutrophil count decreased	Investigations	Capecitabine + Radiation Therapy	14	44
other	Aspartate aminotransferase increased	Investigations	Capecitabine + Radiation Therapy	11	44
other	Weight increased	Investigations	Capecitabine + Radiation Therapy	11	44
other	Gamma-glutamyltransferase increased	Investigations	Capecitabine + Radiation Therapy	5	44
other	Haemoglobin	Investigations	Capecitabine + Radiation Therapy	4	44

1 to 10 of 111Source ClinicalTrials.gov

See all 111 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Capecitabine + Radiation Therapy
Total, other adverse events	Capecitabine + Radiation Therapy	44	44
Total, serious adverse events	Capecitabine + Radiation Therapy	23	44

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

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.

None in this release.

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/NCT01118377

GET https://conductscience.org/api/trials/v1/NCT01118377/events?page=2

API reference For AI assistants