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This single arm study will assess the maximum tolerated dose, and dose-limiting toxicities, of Xeloda administered concurrently with radiation therapy, in children with newly diagnosed diffuse intrinsic brain stem gliomas and high grade gliomas. Xeloda will be administered twice daily, at a starting dose of 500mg/m2 bid, beginning within 24 hours of the start of radiation therapy. Subsequent dose escalations will be in increments of 30%, using a standard dose escalation schema. Post-radiation therapy with Xeloda will continue after a 2 week break. The anticipated time on study treatment is 3-12 months, and the target sample size will not exceed 30 evaluable patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| capecitabine [Xeloda] | Drug | 500mg/m2 po bid (starting dose) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) of Capecitabine. | 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. | Upto 11 weeks. |
| Dose Limiting Toxicities (DLTs) | 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). | Upto 11 weeks |
| Number of Participants With Adverse Events (AE) | 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. | Up to 06 years |
| Number of Participants With Baseline Shift From Normal to Low or High in Hematology Parameters |
| Measure | Description | Time Frame |
|---|---|---|
| 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]) | 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco | California | 94143-0780 | United States | |||
The study consisted of two periods of dosing: A dose-finding treatment period of 11 weeks and a post radiation treatment phase that lasted for 9 weeks.
All participants in the study were enrolled at Pediatric Brain Tumor Consortium (PBTC) institutions in the United States of America (USA), from 24 May 2007 through 27 October 2009.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Capecitabine 500 mg/m^2 | Capecitabine 500 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy. |
| FG001 | Capecitabine 650 mg/m^2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
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For hematology, the parameters assessed were: Hemoglobin, hematocrit, platelet count, RBC, WBC, lymphocytes, monocytes,granulocytes (blasts), neutrophils(segs, bands),eosinophils and basophils. |
| Up to 06 years |
| Number of Participants With Baseline Shift From Normal to Low or High in Blood Chemistry Parameters | 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. | Up to 06 years |
| Day 1 and Day 14 |
| Time to Maximum Plasma Concentration (Tmax) of Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR, 5-FU and FBAL) | 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). | Day 1 and Day 14 |
| 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) | 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). | Day 1 and Day 14 |
| Anti Tumor Activity | Tumor response refers to the best response prior to failure (disease progression, death or second malignancy). | Up to 6 years |
| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| Chicago | Illinois | 60614 | United States |
| Boston | Massachusetts | 02115-6084 | United States |
| Durham | North Carolina | 27710 | United States |
| Philadelphia | Pennsylvania | 19104 | United States |
| Pittsburgh | Pennsylvania | 15261 | United States |
| Houston | Texas | 77030 | United States |
| Seattle | Washington | 98105 | United States |
Capecitabine 650 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy. |
| FG002 | Capecitabine 850 mg/m^2 | Capecitabine 850 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent to treat population defined as all participants enrolled.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Capecitabine 500 mg/m^2 | Capecitabine 500 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy. |
| BG001 | Capecitabine 650 mg/m^2 | Capecitabine 650 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy. |
| BG002 | Capecitabine 850 mg/m^2 | Capecitabine 850 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Gender | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of Capecitabine. | 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. | The safety population consisted of all eligible patients who received at least one dose of capecitabine. | Posted | Number | milligrams | Upto 11 weeks. |
|
|
| ||||||||||||||||||||||||||
| Primary | Dose Limiting Toxicities (DLTs) | 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). | The safety population consisted of all eligible patients who received at least one dose of capecitabine. | Posted | Number | Participants | Upto 11 weeks |
| ||||||||||||||||||||||||||||
| Primary | Number of Participants With Adverse Events (AE) | 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. | The safety population consisted of all eligible patients who received at least one dose of capecitabine. | Posted | Number | Participants | Up to 06 years |
| ||||||||||||||||||||||||||||
| Primary | Number of Participants With Baseline Shift From Normal to Low or High in Hematology Parameters | For hematology, the parameters assessed were: Hemoglobin, hematocrit, platelet count, RBC, WBC, lymphocytes, monocytes,granulocytes (blasts), neutrophils(segs, bands),eosinophils and basophils. | 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. | Posted | Number | Participants | Up to 06 years |
| ||||||||||||||||||||||||||||
| Primary | Number of Participants With Baseline Shift From Normal to Low or High in Blood Chemistry Parameters | 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. | 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. | Posted | Number | Participants | Up to 06 years |
| ||||||||||||||||||||||||||||
| 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]) | 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). | 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. | Posted | Mean | Standard Deviation | ng/mL | Day 1 and Day 14 |
| |||||||||||||||||||||||||||
| Secondary | Time to Maximum Plasma Concentration (Tmax) of Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR, 5-FU and FBAL) | 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). | 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. | Posted | Median | Full Range | Hour | Day 1 and Day 14 |
| |||||||||||||||||||||||||||
| 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) | 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). | 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. | Posted | Mean | Standard Deviation | h*ng/mL | Day 1 and Day 14 |
| |||||||||||||||||||||||||||
| Secondary | Anti Tumor Activity | Tumor response refers to the best response prior to failure (disease progression, death or second malignancy). | 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. | Posted | Up to 6 years |
|
Up to 6 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Capecitabine 500 mg/m^2 | Capecitabine 500 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy | 2 | 4 | 3 | 4 | ||
| EG001 | Capecitabine 650 mg/m^2 | Capecitabine 650 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy | 1 | 12 | 12 | 12 | ||
| EG002 | Capecitabine 850 mg/m^2 | Capecitabine 850 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy | 3 | 6 | 6 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Convulsion | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dermatitis Exfoliative | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Skin Exfoliation | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Abdominal Infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Haemoglobin | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Neutrophil count | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Blood bicarbonate decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dermatitis exfoliative | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Facial nerve disorder | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| VIth nerve disorder | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Glossopharyngeal nerve disorder | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Nystagmus | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Gingival infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Radiation mucositis | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cushingoid | Endocrine disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypertension | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Extraocular muscle disorder | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Euphoric mood | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Psychotic Disorder | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Oculomotor nerve operation | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roche Trial Information Hotline | Hoffmann-La Roche AG | +41 61 6878333 | global.trial_information@roche.com |
| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| Male |
|
Capecitabine 650 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
| OG002 | Capecitabine 850 mg/m^2 | Capecitabine 850 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy |
|
|
Capecitabine 850 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
|
|
|
|
| OG002 | Capecitabine 850 mg/m^2 | Capecitabine 850 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy |
|
|
| OG002 | Capecitabine 850 mg/m^2 | Capecitabine 850 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy |
|
|
Capecitabine 850 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy |
|
|
| Capecitabine 850 mg/m^2 |
Capecitabine 850 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy |
|
|
|