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This study will assess the safety and efficacy of Xeloda, given in combination with standard chemotherapy regimens, for the first-line treatment of advanced and/or metastatic gastric cancer. All patients will receive Xeloda in combination with one of 4 standard chemotherapy regimens; the dose of Xeloda will be from 625mg/m2 - 1000mg/m2 bid orally, depending on the chemotherapy regimen used. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cisplatin / Capecitabine | Experimental | Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, oral, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks. |
|
| Epirubicin / Cisplatin / Capecitabine | Experimental | Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks. |
|
| Epirubicin / Oxaliplatin / Capecitabine | Experimental | Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks. |
|
| Docetaxel / Cisplatin / Capecitabine | Experimental | Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisplatin | Drug | 80 mg/m2/day, intravenous (IV), every 3 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Grade 3 Hand-Foot Syndrome (HFS) | Approximately 3.25 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | ORR was defined as the percentage of participants achieving either a complete response (CR) or a partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. CR was defined as the disappearance of all target lesions; for non-target lesions, disappearance of lesions and normal tumor marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using the baseline sum LD as reference. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcoy | Alicante | 03804 | Spain | |||
Not provided
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Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cisplatin / Capecitabine | Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks |
| FG001 | Epirubicin / Cisplatin / Capecitabine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Capecitabine |
| Drug |
1,000 mg/m2, oral, twice daily for 2 weeks, followed by 1 week of rest in each cycle |
|
|
| Epirubicin | Drug | 50 mg/m2/day, IV, every 3 weeks |
|
| Cisplatin | Drug | 60 mg/m2/day, IV, every 3 weeks |
|
| Capecitabine | Drug | 625 mg/m2, oral, twice daily per 3-week cycle |
|
|
| Oxaliplatin | Drug | 130 mg/m2/day, IV, every 3 weeks |
|
| Docetaxel | Drug | 60 mg/m2/day, IV, every 3 weeks |
|
| Capecitabine | Drug | 825 mg/m2, oral, twice daily for 2 weeks |
|
|
| Approximately 3.25 years |
| Progression-Free Survival (PFS) | PFS was defined as the time from the start of treatment to the first documentation of disease progression or death for any cause. Disease progression was based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria and was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. | Approximately 3.25 years |
| Overall Survival (OS) | OS was defined as the time elapsing from the date of the start of treatment until death, or last known follow-up. | Approximately 3.25 years |
| Duration of Response | Duration of Response was defined as the time of complete response (CR) or partial response (PR) until the first date of recurrent or progressive disease, based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. CR was defined as the disappearance of all target lesions; for non-target lesions, disappearance of lesions and normal tumor marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using the baseline sum LD as reference. Progressive disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. | Approximately 3.25 years |
| Time to Response | Time to Response was defined as the date of start of treatment until the first date of complete response (CR) or a partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. CR was defined as the disappearance of all target lesions; for non-target lesions, disappearance of lesions and normal tumor marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using the baseline sum LD as reference. | Approximately 3.25 years |
| Ávila |
| Avila |
| 05071 |
| Spain |
| Palma de Mallorca | Balearic Islands | 07014 | Spain |
| Palma de Mallorca | Balearic Islands | 07198 | Spain |
| Barcelona | Barcelona | 08916 | Spain |
| Burgos | Burgos | 09006 | Spain |
| Cadiz | Cadiz | 11009 | Spain |
| Jerez de la Frontera | Cadiz | 11407 | Spain |
| Puerto Real | Cadiz | 11510 | Spain |
| Castellon | Castellon | 12002 | Spain |
| Córdoba | Cordoba | 14004 | Spain |
| Girona | Girona | 17007 | Spain |
| Granada | Granada | 18003 | Spain |
| Granada | Granada | 18014 | Spain |
| Guadalajara | Guadalajara | 19002 | Spain |
| Donostia / San Sebastian | Guipuzcoa | 20080 | Spain |
| Barbastro | Huesca | 22300 | Spain |
| Huesca | Huesca | 22004 | Spain |
| Jaén | Jaen | 23007 | Spain |
| A Coruña | La Coruña | 15006 | Spain |
| A Coruña | La Coruña | 15009 | Spain |
| Ferrol | La Coruña | 15405 | Spain |
| Santiago de Compostela | La Coruña | 15706 | Spain |
| Logroño | La Rioja | 26006 | Spain |
| León | Leon | 24071 | Spain |
| Lleida | Lerida | 25198 | Spain |
| Lugo | Lugo | 27004 | Spain |
| Alcorcón | Madrid | 28922 | Spain |
| Madrid | Madrid | 28033 | Spain |
| Madrid | Madrid | 28034 | Spain |
| Madrid | Madrid | 28041 | Spain |
| Madrid | Madrid | 28050 | Spain |
| Madrid | Madrid | 28222 | Spain |
| Madrid | Madrid | 28223 | Spain |
| Madrid | Madrid | 28935 | Spain |
| Murcia | Murcia | 30008 | Spain |
| Navarra | Navarre | 31008 | Spain |
| Pamplona | Navarre | 31008 | Spain |
| Ourense | Orense | 32005 | Spain |
| Palencia | Palencia | 34005 | Spain |
| Pontevedra | Pontevedra | 36002 | Spain |
| Vigo | Pontevedra | 36312 | Spain |
| Gijón | Principality of Asturias | 33394 | Spain |
| Salamanca | Salamanca | 37007 | Spain |
| Seville | Sevilla | 41013 | Spain |
| San Cristóbal de La Laguna | Tenerife | 38320 | Spain |
| Toledo | Toledo | 45004 | Spain |
| Valencia | Valencia | 41014 | Spain |
| Valencia | Valencia | 46026 | Spain |
| Bilbao | Vizcaya | 48013 | Spain |
| Zaragoza | Zaragoza | 50009 | Spain |
Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks |
| FG002 | Epirubicin / Oxaliplatin / Capecitabine | Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks |
| FG003 | Docetaxel / Cisplatin / Capecitabine | Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cisplatin / Capecitabine | Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks |
| BG001 | Epirubicin / Cisplatin / Capecitabine | Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks |
| BG002 | Epirubicin / Oxaliplatin / Capecitabine | Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks |
| BG003 | Docetaxel / Cisplatin / Capecitabine | Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks. |
| BG004 | 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 | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | 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 | Percentage of Participants With Grade 3 Hand-Foot Syndrome (HFS) | Safety population: All participants who received at least one dose of study medication. | Posted | Number | percentage of participants | Approximately 3.25 years |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Overall Response Rate (ORR) | ORR was defined as the percentage of participants achieving either a complete response (CR) or a partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. CR was defined as the disappearance of all target lesions; for non-target lesions, disappearance of lesions and normal tumor marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using the baseline sum LD as reference. | Intent-to-Treat (ITT) population: included all participants who received at least one dose of study medication and had baseline and at least one subsequent tumor assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | Approximately 3.25 years |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) | PFS was defined as the time from the start of treatment to the first documentation of disease progression or death for any cause. Disease progression was based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria and was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. | Safety population: All participants who received at least one dose of study medication. | Posted | Median | 95% Confidence Interval | months | Approximately 3.25 years |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the time elapsing from the date of the start of treatment until death, or last known follow-up. | Safety population: All participants who received at least one dose of study medication. | Posted | Median | 95% Confidence Interval | months | Approximately 3.25 years |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response | Duration of Response was defined as the time of complete response (CR) or partial response (PR) until the first date of recurrent or progressive disease, based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. CR was defined as the disappearance of all target lesions; for non-target lesions, disappearance of lesions and normal tumor marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using the baseline sum LD as reference. Progressive disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. | Safety population: All participants who received at least one dose of study medication. Only participants who reported either a complete response or a partial response were assessed. | Posted | Mean | Standard Deviation | days | Approximately 3.25 years |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Time to Response | Time to Response was defined as the date of start of treatment until the first date of complete response (CR) or a partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. CR was defined as the disappearance of all target lesions; for non-target lesions, disappearance of lesions and normal tumor marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using the baseline sum LD as reference. | Safety population: All participants who received at least one dose of study medication. Only participants who reported either a complete response or a partial response were assessed. | Posted | Mean | Standard Deviation | days | Approximately 3.25 years |
|
Approximately 3.25 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 | Cisplatin / Capecitabine | Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks | 9 | 41 | 39 | 41 | ||
| EG001 | Epirubicin / Cisplatin / Capecitabine | Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks | 12 | 32 | 30 | 32 | ||
| EG002 | Epirubicin / Oxaliplatin / Capecitabine | Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks | 12 | 27 | 27 | 27 | ||
| EG003 | Docetaxel / Cisplatin / Capecitabine | Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks. | 23 | 58 | 54 | 58 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Clostridium | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Bacteraemia gastroenteritis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 8.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 8.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Cerebellar infarction | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Paraplegia | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Limb operation | Surgical and medical procedures | MedDRA 8.1 | Systematic Assessment |
| |
| Arterial thrombosis limb | Vascular disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 8.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 8.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Dysaesthesia | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Onycholysis | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 8.1 | 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 | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D000069287 | Capecitabine |
| D015251 | Epirubicin |
| D000077150 | Oxaliplatin |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| 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 |
| D004317 | Doxorubicin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D056831 | Coordination Complexes |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| Male |
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Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks |
| OG003 | Docetaxel / Cisplatin / Capecitabine | Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks. |
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| OG003 | Docetaxel / Cisplatin / Capecitabine | Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks. |
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| Docetaxel / Cisplatin / Capecitabine |
Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks. |
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| OG002 | Epirubicin / Oxaliplatin / Capecitabine | Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks |
| OG003 | Docetaxel / Cisplatin / Capecitabine | Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks. |
|
|
Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks |
| OG003 | Docetaxel / Cisplatin / Capecitabine | Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks. |
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