Trial · NCT00532948
A Study of Xeloda (Capecitabine) Plus Radiation Therapy in Children With Newly Diagnosed Gliomas
NCT00532948, Phase 1, Completed, Hoffmann-La Roche; results first posted 2016-03-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Xeloda (Capecitabine) Plus Radiation Therapy in Children With Newly Diagnosed Gliomas. Trials, record NCT00532948. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00532948
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Xeloda (Capecitabine) Plus Radiation Therapy in Children With Newly Diagnosed Gliomas
- NCT number
- NCT00532948
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 24 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Glioma
- Interventions
- capecitabine [Xeloda]
- First posted
- 2007-09-21
- Last updated
- 2016-12-07
- Results first posted
- 2016-03-15
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of Capecitabine. | Upto 11 weeks. | The MTD was the dose level at which six evaluable patients had been treated and at most one patient experienced a dose limiting toxicity (DLT) and the next highest dose level was too toxic. Dose escalation occurred if 0 out of 3 or at most 1 out of 6 patients experienced DLT while being treated at a dose level; otherwise the dose was declared unsafe and thus above the MTD. |
| Primary | Dose Limiting Toxicities (DLTs) | Upto 11 weeks | DLT was defined as any of the following events occurring during the 11 week dose-finding period: any event that leads to interruption of planned radiation for 5 consecutive days or 10 days total; Grade 4 neutropenia or thrombocytopenia; Grade 3 thrombocytopenia that required a platelet transfusion on 2 or more occasions; any Grade 3 or 4 non-hematologic toxicity (with the exception of grade 3 nausea or vomiting of less than 5 days duration, Grade 3 transaminases that returned to baseline value within 7 days of study drug interruption and that did not recur upon re-challenge with study drug, and/or Grade 3 fever or infection of \<5 days duration); Grade 2 non-hematologic toxicities that persisted for \>7 days and required treatment interruption, or any other capecitabine-related adverse events that required need for dose reduction or permanent cessation of therapy, interruption of study drug for \>7 days or recurred on re-challenge with capecitabine rapidly disintegrating tablets (RDTs). |
| Primary | Number of Participants With Adverse Events (AE) | Up to 06 years | An AE is an unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Toxicity was monitored and graded according to the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Adverse events that were not included in the CTCAEv3.0 were reported and graded under the other AE within the appropriate category. |
| Primary | Number of Participants With Baseline Shift From Normal to Low or High in Hematology Parameters | Up to 06 years | For hematology, the parameters assessed were: Hemoglobin, hematocrit, platelet count, RBC, WBC, lymphocytes, monocytes,granulocytes (blasts), neutrophils(segs, bands),eosinophils and basophils. |
| Primary | Number of Participants With Baseline Shift From Normal to Low or High in Blood Chemistry Parameters | Up to 06 years | For blood chemistry, the parameters assessed were: Sodium, potassium, calcium, magnesium, chloride, bicarbonate, total protein, albumin, alkaline phosphatase, alanine transaminase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN), Lactate dehydrogenase (LDH), total bilirubin, direct bilirubin, indirect bilirubin, creatinine (serum creatinine or creatinine clearance), glucose. |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of Capecitabine and Its Metabolites (5'-Deoxy-5-Fluorocytidine [5'-DFCR], 5'-Deoxy-5-Fluorouridine [5'-DFUR], 5-Fluorouracil [5-FU] and Alpha-fluoro-beta-alanine [FBAL]) | Day 1 and Day 14 | The maximum observed plasma concentration of capecitabine and its metabolites. Participants who consented to participating in the PK studies were randomized to either sampling series A or Series B. The collection time points included 2 different series, Series A (Baseline \[pre-dose\], 10 mins, 30 mins, 1, 2.5, 6, 8 and 10 hours after dosing) and Series B (Baseline \[pre-dose\], 15 minutes, 45 minutes, 1.5, 4, 8 and 10 hours after dosing). |
| Secondary | Time to Maximum Plasma Concentration (Tmax) of Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR, 5-FU and FBAL) | Day 1 and Day 14 | Tmax is the corresponding time at which Cmax occurs of capecitabine and its metabolites.Participants who consented to participating in the PK studies were randomized to either sampling series A or Series B. The collection time points included 2 different series, Series A (Baseline \[pre-dose\], 10 mins, 30 mins, 1, 2.5, 6, 8 and 10 hours after dosing) and Series B (Baseline \[pre-dose\], 15 minutes, 45 minutes, 1.5, 4, 8 and 10 hours after dosing). |
| Secondary | The Area Under the Plasma Concentration-time Curve From Time of Dosing to the Last Measurable Concentration (AUClast) of Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR, 5-FU and FBAL) | Day 1 and Day 14 | AUC last concentration of capecitabine and its metabolites. Participants who consented to participating in the PK studies were randomized to either sampling series A or Series B. The collection time points included 2 different series, Series A (Baseline \[pre-dose\], 10 mins, 30 mins, 1, 2.5, 6, 8 and 10 hours after dosing) and Series B (Baseline \[pre-dose\], 15 minutes, 45 minutes, 1.5, 4, 8 and 10 hours after dosing). |
| Secondary | Anti Tumor Activity | Up to 6 years | Tumor response refers to the best response prior to failure (disease progression, death or second malignancy). |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD) of Capecitabine. | Upto 11 weeks. | The safety population consisted of all eligible patients who received at least one dose of capecitabine. | milligrams | NUMBER |
| PRIMARY | Dose Limiting Toxicities (DLTs) | Upto 11 weeks | The safety population consisted of all eligible patients who received at least one dose of capecitabine. | Participants | NUMBER |
| PRIMARY | Number of Participants With Adverse Events (AE) | Up to 06 years | The safety population consisted of all eligible patients who received at least one dose of capecitabine. | Participants | NUMBER |
| PRIMARY | Number of Participants With Baseline Shift From Normal to Low or High in Hematology Parameters | Up to 06 years | The safety population consisted of all eligible patients who received at least one dose of capecitabine. Participants available at a particular time point were included in analysis. | Participants | NUMBER |
| PRIMARY | Number of Participants With Baseline Shift From Normal to Low or High in Blood Chemistry Parameters | Up to 06 years | The safety population consisted of all eligible patients who received at least one dose of capecitabine. Participants available at a particular time point were included in analysis. | Participants | NUMBER |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) of Capecitabine and Its Metabolites (5'-Deoxy-5-Fluorocytidine [5'-DFCR], 5'-Deoxy-5-Fluorouridine [5'-DFUR], 5-Fluorouracil [5-FU] and Alpha-fluoro-beta-alanine [FBAL]) | Day 1 and Day 14 | The safety population consisted of all eligible patients who received at least one dose of capecitabine. Participants available at a particular time point were included in analysis. | ng/mL | MEAN |
| SECONDARY | Time to Maximum Plasma Concentration (Tmax) of Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR, 5-FU and FBAL) | Day 1 and Day 14 | The safety population consisted of all eligible patients who received at least one dose of capecitabine. Participants available at a particular time point were included in analysis. | Hour | MEDIAN |
| SECONDARY | The Area Under the Plasma Concentration-time Curve From Time of Dosing to the Last Measurable Concentration (AUClast) of Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR, 5-FU and FBAL) | Day 1 and Day 14 | The safety population consisted of all eligible patients who received at least one dose of capecitabine. Participants available at a particular time point were included in analysis. | h*ng/mL | MEAN |
| SECONDARY | Anti Tumor Activity | Up to 6 years | Efficacy data of the present study (NO18517 - NCT00532948) were pre-specified to be combined with efficacy data of the Phase 2 portion of this Study, NO21125 (NCT01118377) for analysis. Results are currently posted in the record of Study NO21125. |
Source ClinicalTrials.gov
Results by group265
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD) of Capecitabine. | Capecitabine (Overall) | 650 | milligrams | ||
| Dose Limiting Toxicities (DLTs) | Capecitabine 500 mg/m^2 | 0 | Participants | ||
| Dose Limiting Toxicities (DLTs) | Capecitabine 650 mg/m^2 | 3 | Participants | ||
| Dose Limiting Toxicities (DLTs) | Capecitabine 850 mg/m^2 | 3 | Participants | ||
| Number of Participants With Adverse Events (AE) | Capecitabine 500 mg/m^2 | 3 | Participants | ||
| Number of Participants With Adverse Events (AE) | Capecitabine 650 mg/m^2 | 12 | Participants | ||
| Number of Participants With Adverse Events (AE) | Capecitabine 850 mg/m^2 | 6 | Participants | ||
| Number of Participants With Baseline Shift From Normal to Low or High in Hematology Parameters | Capecitabine 500 mg/m^2 | Haematocrit, normal to low, n=3,1,5 | 2 | Participants | |
| Number of Participants With Baseline Shift From Normal to Low or High in Hematology Parameters | Capecitabine 650 mg/m^2 | Haematocrit, normal to low, n=3,1,5 | 1 | Participants | |
| Number of Participants With Baseline Shift From Normal to Low or High in Hematology Parameters | Capecitabine 850 mg/m^2 | Haematocrit, normal to low, n=3,1,5 | 4 | Participants |
1 to 10 of 265Source ClinicalTrials.gov
See all 265 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Capecitabine 500 mg/m^2 | 4 | |
| Overall Study | STARTED | Capecitabine 650 mg/m^2 | 14 | |
| Overall Study | STARTED | Capecitabine 850 mg/m^2 | 6 | |
| Overall Study | COMPLETED | Capecitabine 500 mg/m^2 | 0 | |
| Overall Study | COMPLETED | Capecitabine 650 mg/m^2 | 9 | |
| Overall Study | COMPLETED | Capecitabine 850 mg/m^2 | 2 | |
| Overall Study | NOT COMPLETED | Capecitabine 500 mg/m^2 | 4 | |
| Overall Study | NOT COMPLETED | Capecitabine 650 mg/m^2 | 5 | |
| Overall Study | NOT COMPLETED | Capecitabine 850 mg/m^2 | 4 |
Source ClinicalTrials.gov
Adverse events237
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 |
|---|---|---|---|---|---|---|
| other | Alanine aminotransferase increased | Investigations | Capecitabine 500 mg/m^2 | 1 | 4 | |
| other | Alanine aminotransferase increased | Investigations | Capecitabine 650 mg/m^2 | 9 | 12 | |
| other | Alanine aminotransferase increased | Investigations | Capecitabine 850 mg/m^2 | 3 | 6 | |
| other | Haemoglobin | Investigations | Capecitabine 500 mg/m^2 | 1 | 4 | |
| other | Haemoglobin | Investigations | Capecitabine 650 mg/m^2 | 4 | 12 | |
| other | Haemoglobin | Investigations | Capecitabine 850 mg/m^2 | 2 | 6 | |
| other | Neutrophil count | Investigations | Capecitabine 500 mg/m^2 | 2 | 4 | |
| other | Neutrophil count | Investigations | Capecitabine 650 mg/m^2 | 4 | 12 | |
| other | Neutrophil count | Investigations | Capecitabine 850 mg/m^2 | 1 | 6 | |
| other | Platelet count decreased | Investigations | Capecitabine 500 mg/m^2 | 2 | 4 |
1 to 10 of 237Source ClinicalTrials.gov
See all 237 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Capecitabine 500 mg/m^2 | ||
| Total, all-cause mortality | Capecitabine 650 mg/m^2 | ||
| Total, all-cause mortality | Capecitabine 850 mg/m^2 | ||
| Total, other adverse events | Capecitabine 500 mg/m^2 | 3 | 4 |
| Total, other adverse events | Capecitabine 650 mg/m^2 | 12 | 12 |
| Total, other adverse events | Capecitabine 850 mg/m^2 | 6 | 6 |
| Total, serious adverse events | Capecitabine 500 mg/m^2 | 2 | 4 |
| Total, serious adverse events | Capecitabine 650 mg/m^2 | 1 | 12 |
| Total, serious adverse events | Capecitabine 850 mg/m^2 | 3 | 6 |
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.
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/NCT00532948
GET https://conductscience.org/api/trials/v1/NCT00532948/results?page=2