Trial Outcomes & Findings for A Study of Xeloda (Capecitabine) in Combination With Chemotherapy in Patients With Advanced and/or Metastatic Gastric Cancer. (NCT NCT00454636)
NCT ID: NCT00454636
Last Updated: 2016-09-29
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
158 participants
Primary outcome timeframe
Approximately 3.25 years
Results posted on
2016-09-29
Participant Flow
Participant milestones
| Measure |
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
|
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
|
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
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
41
|
32
|
27
|
58
|
|
Overall Study
COMPLETED
|
10
|
9
|
7
|
26
|
|
Overall Study
NOT COMPLETED
|
31
|
23
|
20
|
32
|
Reasons for withdrawal
| Measure |
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
|
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
|
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
|
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.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
10
|
6
|
9
|
15
|
|
Overall Study
Disease Progression
|
11
|
12
|
4
|
11
|
|
Overall Study
Protocol Violation
|
3
|
2
|
3
|
3
|
|
Overall Study
Death
|
6
|
1
|
1
|
1
|
|
Overall Study
Patient refusal
|
1
|
1
|
3
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study of Xeloda (Capecitabine) in Combination With Chemotherapy in Patients With Advanced and/or Metastatic Gastric Cancer.
Baseline characteristics by cohort
| Measure |
Cisplatin / Capecitabine
n=41 Participants
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
|
Epirubicin / Cisplatin / Capecitabine
n=32 Participants
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
n=27 Participants
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
n=58 Participants
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.
|
Total
n=158 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
66 years
n=5 Participants
|
60 years
n=7 Participants
|
62 years
n=5 Participants
|
58 years
n=4 Participants
|
61 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
112 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Approximately 3.25 yearsPopulation: Safety population: All participants who received at least one dose of study medication.
Outcome measures
| Measure |
Cisplatin / Capecitabine
n=41 Participants
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
|
Epirubicin / Cisplatin / Capecitabine
n=32 Participants
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
n=27 Participants
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
n=58 Participants
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.
|
|---|---|---|---|---|
|
Percentage of Participants With Grade 3 Hand-Foot Syndrome (HFS)
|
2.4 percentage of participants
|
6.3 percentage of participants
|
3.7 percentage of participants
|
5.2 percentage of participants
|
SECONDARY outcome
Timeframe: Approximately 3.25 yearsPopulation: 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.
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.
Outcome measures
| Measure |
Cisplatin / Capecitabine
n=30 Participants
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
|
Epirubicin / Cisplatin / Capecitabine
n=27 Participants
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
n=23 Participants
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
n=52 Participants
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.
|
|---|---|---|---|---|
|
Overall Response Rate (ORR)
|
43.3 percentage of participants
Interval 25.5 to 62.6
|
40.7 percentage of participants
Interval 22.4 to 61.2
|
69.6 percentage of participants
Interval 47.1 to 86.8
|
59.6 percentage of participants
Interval 45.1 to 73.0
|
SECONDARY outcome
Timeframe: Approximately 3.25 yearsPopulation: Safety population: All participants who received at least one dose of study medication.
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.
Outcome measures
| Measure |
Cisplatin / Capecitabine
n=41 Participants
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
|
Epirubicin / Cisplatin / Capecitabine
n=32 Participants
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
n=27 Participants
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
n=58 Participants
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.
|
|---|---|---|---|---|
|
Progression-Free Survival (PFS)
|
4.43 months
Interval 3.1 to 7.7
|
5.17 months
Interval 2.97 to 6.23
|
7.07 months
Interval 3.03 to 11.23
|
7.87 months
Interval 5.53 to 9.8
|
SECONDARY outcome
Timeframe: Approximately 3.25 yearsPopulation: Safety population: All participants who received at least one dose of study medication.
OS was defined as the time elapsing from the date of the start of treatment until death, or last known follow-up.
Outcome measures
| Measure |
Cisplatin / Capecitabine
n=41 Participants
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
|
Epirubicin / Cisplatin / Capecitabine
n=32 Participants
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
n=27 Participants
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
n=58 Participants
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.
|
|---|---|---|---|---|
|
Overall Survival (OS)
|
10.23 months
Interval 4.73 to 12.6
|
8.87 months
Interval 5.3 to 14.57
|
13.87 months
Interval 5.37 to 24.07
|
12.43 months
Interval 10.6 to 15.67
|
SECONDARY outcome
Timeframe: Approximately 3.25 yearsPopulation: 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.
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.
Outcome measures
| Measure |
Cisplatin / Capecitabine
n=13 Participants
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
|
Epirubicin / Cisplatin / Capecitabine
n=11 Participants
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
n=16 Participants
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
n=31 Participants
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.
|
|---|---|---|---|---|
|
Duration of Response
|
308.92 days
Standard Deviation 348.44
|
154.09 days
Standard Deviation 167.83
|
203.06 days
Standard Deviation 232.54
|
205.52 days
Standard Deviation 228.44
|
SECONDARY outcome
Timeframe: Approximately 3.25 yearsPopulation: 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.
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.
Outcome measures
| Measure |
Cisplatin / Capecitabine
n=13 Participants
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
|
Epirubicin / Cisplatin / Capecitabine
n=11 Participants
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
n=16 Participants
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
n=31 Participants
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.
|
|---|---|---|---|---|
|
Time to Response
|
132.92 days
Standard Deviation 52.24
|
126.64 days
Standard Deviation 74.69
|
123.50 days
Standard Deviation 60.22
|
138.16 days
Standard Deviation 44.29
|
Adverse Events
Cisplatin / Capecitabine
Serious events: 9 serious events
Other events: 39 other events
Deaths: 0 deaths
Epirubicin / Cisplatin / Capecitabine
Serious events: 12 serious events
Other events: 30 other events
Deaths: 0 deaths
Epirubicin / Oxaliplatin / Capecitabine
Serious events: 12 serious events
Other events: 27 other events
Deaths: 0 deaths
Docetaxel / Cisplatin / Capecitabine
Serious events: 23 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cisplatin / Capecitabine
n=41 participants at risk
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
|
Epirubicin / Cisplatin / Capecitabine
n=32 participants at risk
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
n=27 participants at risk
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
n=58 participants at risk
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.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.4%
1/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
3.7%
1/27 • Approximately 3.25 years
|
1.7%
1/58 • Approximately 3.25 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.4%
1/41 • Approximately 3.25 years
|
12.5%
4/32 • Approximately 3.25 years
|
7.4%
2/27 • Approximately 3.25 years
|
6.9%
4/58 • Approximately 3.25 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
0.00%
0/27 • Approximately 3.25 years
|
5.2%
3/58 • Approximately 3.25 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
0.00%
0/27 • Approximately 3.25 years
|
1.7%
1/58 • Approximately 3.25 years
|
|
Cardiac disorders
Acute myocardial infarction
|
2.4%
1/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
0.00%
0/27 • Approximately 3.25 years
|
0.00%
0/58 • Approximately 3.25 years
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
0.00%
0/27 • Approximately 3.25 years
|
1.7%
1/58 • Approximately 3.25 years
|
|
Cardiac disorders
Cardio-respiratory arrest
|
2.4%
1/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
0.00%
0/27 • Approximately 3.25 years
|
0.00%
0/58 • Approximately 3.25 years
|
|
Gastrointestinal disorders
Abdominal pain
|
2.4%
1/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
0.00%
0/27 • Approximately 3.25 years
|
0.00%
0/58 • Approximately 3.25 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.4%
1/41 • Approximately 3.25 years
|
3.1%
1/32 • Approximately 3.25 years
|
0.00%
0/27 • Approximately 3.25 years
|
0.00%
0/58 • Approximately 3.25 years
|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
1/41 • Approximately 3.25 years
|
6.2%
2/32 • Approximately 3.25 years
|
3.7%
1/27 • Approximately 3.25 years
|
1.7%
1/58 • Approximately 3.25 years
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
0.00%
0/27 • Approximately 3.25 years
|
1.7%
1/58 • Approximately 3.25 years
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
3.7%
1/27 • Approximately 3.25 years
|
0.00%
0/58 • Approximately 3.25 years
|
|
Gastrointestinal disorders
Haematemesis
|
2.4%
1/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
0.00%
0/27 • Approximately 3.25 years
|
0.00%
0/58 • Approximately 3.25 years
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/41 • Approximately 3.25 years
|
3.1%
1/32 • Approximately 3.25 years
|
7.4%
2/27 • Approximately 3.25 years
|
5.2%
3/58 • Approximately 3.25 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
0.00%
0/27 • Approximately 3.25 years
|
3.4%
2/58 • Approximately 3.25 years
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/41 • Approximately 3.25 years
|
3.1%
1/32 • Approximately 3.25 years
|
0.00%
0/27 • Approximately 3.25 years
|
0.00%
0/58 • Approximately 3.25 years
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
0.00%
0/27 • Approximately 3.25 years
|
1.7%
1/58 • Approximately 3.25 years
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
1/41 • Approximately 3.25 years
|
3.1%
1/32 • Approximately 3.25 years
|
3.7%
1/27 • Approximately 3.25 years
|
8.6%
5/58 • Approximately 3.25 years
|
|
General disorders
Asthenia
|
2.4%
1/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
3.7%
1/27 • Approximately 3.25 years
|
0.00%
0/58 • Approximately 3.25 years
|
|
General disorders
Chest pain
|
0.00%
0/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
0.00%
0/27 • Approximately 3.25 years
|
1.7%
1/58 • Approximately 3.25 years
|
|
General disorders
General physical health deterioration
|
0.00%
0/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
3.7%
1/27 • Approximately 3.25 years
|
0.00%
0/58 • Approximately 3.25 years
|
|
General disorders
Pyrexia
|
0.00%
0/41 • Approximately 3.25 years
|
3.1%
1/32 • Approximately 3.25 years
|
3.7%
1/27 • Approximately 3.25 years
|
0.00%
0/58 • Approximately 3.25 years
|
|
Infections and infestations
Anal abscess
|
0.00%
0/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
0.00%
0/27 • Approximately 3.25 years
|
1.7%
1/58 • Approximately 3.25 years
|
|
Infections and infestations
Clostridium
|
0.00%
0/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
0.00%
0/27 • Approximately 3.25 years
|
1.7%
1/58 • Approximately 3.25 years
|
|
Infections and infestations
Bacteraemia gastroenteritis
|
0.00%
0/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
0.00%
0/27 • Approximately 3.25 years
|
1.7%
1/58 • Approximately 3.25 years
|
|
Infections and infestations
Pneumonia
|
0.00%
0/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
3.7%
1/27 • Approximately 3.25 years
|
0.00%
0/58 • Approximately 3.25 years
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
0.00%
0/27 • Approximately 3.25 years
|
1.7%
1/58 • Approximately 3.25 years
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
0.00%
0/27 • Approximately 3.25 years
|
1.7%
1/58 • Approximately 3.25 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
3.7%
1/27 • Approximately 3.25 years
|
0.00%
0/58 • Approximately 3.25 years
|
|
Nervous system disorders
Cerebellar infarction
|
0.00%
0/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
0.00%
0/27 • Approximately 3.25 years
|
1.7%
1/58 • Approximately 3.25 years
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
0.00%
0/27 • Approximately 3.25 years
|
1.7%
1/58 • Approximately 3.25 years
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
3.7%
1/27 • Approximately 3.25 years
|
0.00%
0/58 • Approximately 3.25 years
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
3.7%
1/27 • Approximately 3.25 years
|
0.00%
0/58 • Approximately 3.25 years
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
0.00%
0/27 • Approximately 3.25 years
|
1.7%
1/58 • Approximately 3.25 years
|
|
Nervous system disorders
Dizziness
|
2.4%
1/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
0.00%
0/27 • Approximately 3.25 years
|
0.00%
0/58 • Approximately 3.25 years
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
3.7%
1/27 • Approximately 3.25 years
|
0.00%
0/58 • Approximately 3.25 years
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
3.7%
1/27 • Approximately 3.25 years
|
0.00%
0/58 • Approximately 3.25 years
|
|
Nervous system disorders
Paraplegia
|
0.00%
0/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
0.00%
0/27 • Approximately 3.25 years
|
1.7%
1/58 • Approximately 3.25 years
|
|
Nervous system disorders
Syncope
|
2.4%
1/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
0.00%
0/27 • Approximately 3.25 years
|
0.00%
0/58 • Approximately 3.25 years
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/41 • Approximately 3.25 years
|
3.1%
1/32 • Approximately 3.25 years
|
0.00%
0/27 • Approximately 3.25 years
|
0.00%
0/58 • Approximately 3.25 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
3.7%
1/27 • Approximately 3.25 years
|
0.00%
0/58 • Approximately 3.25 years
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.4%
1/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
0.00%
0/27 • Approximately 3.25 years
|
0.00%
0/58 • Approximately 3.25 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
0.00%
0/27 • Approximately 3.25 years
|
1.7%
1/58 • Approximately 3.25 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
3.7%
1/27 • Approximately 3.25 years
|
0.00%
0/58 • Approximately 3.25 years
|
|
Surgical and medical procedures
Limb operation
|
0.00%
0/41 • Approximately 3.25 years
|
3.1%
1/32 • Approximately 3.25 years
|
0.00%
0/27 • Approximately 3.25 years
|
0.00%
0/58 • Approximately 3.25 years
|
|
Vascular disorders
Arterial thrombosis limb
|
0.00%
0/41 • Approximately 3.25 years
|
3.1%
1/32 • Approximately 3.25 years
|
0.00%
0/27 • Approximately 3.25 years
|
0.00%
0/58 • Approximately 3.25 years
|
|
Vascular disorders
Deep vein thrombosis
|
4.9%
2/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
0.00%
0/27 • Approximately 3.25 years
|
0.00%
0/58 • Approximately 3.25 years
|
|
Vascular disorders
Peripheral ischaemia
|
2.4%
1/41 • Approximately 3.25 years
|
6.2%
2/32 • Approximately 3.25 years
|
0.00%
0/27 • Approximately 3.25 years
|
0.00%
0/58 • Approximately 3.25 years
|
Other adverse events
| Measure |
Cisplatin / Capecitabine
n=41 participants at risk
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
|
Epirubicin / Cisplatin / Capecitabine
n=32 participants at risk
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
n=27 participants at risk
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
n=58 participants at risk
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.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
24.4%
10/41 • Approximately 3.25 years
|
37.5%
12/32 • Approximately 3.25 years
|
25.9%
7/27 • Approximately 3.25 years
|
32.8%
19/58 • Approximately 3.25 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/41 • Approximately 3.25 years
|
3.1%
1/32 • Approximately 3.25 years
|
7.4%
2/27 • Approximately 3.25 years
|
3.4%
2/58 • Approximately 3.25 years
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.4%
1/41 • Approximately 3.25 years
|
6.2%
2/32 • Approximately 3.25 years
|
14.8%
4/27 • Approximately 3.25 years
|
6.9%
4/58 • Approximately 3.25 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
43.9%
18/41 • Approximately 3.25 years
|
31.2%
10/32 • Approximately 3.25 years
|
48.1%
13/27 • Approximately 3.25 years
|
13.8%
8/58 • Approximately 3.25 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
19.5%
8/41 • Approximately 3.25 years
|
3.1%
1/32 • Approximately 3.25 years
|
22.2%
6/27 • Approximately 3.25 years
|
5.2%
3/58 • Approximately 3.25 years
|
|
Gastrointestinal disorders
Abdominal pain
|
12.2%
5/41 • Approximately 3.25 years
|
15.6%
5/32 • Approximately 3.25 years
|
14.8%
4/27 • Approximately 3.25 years
|
6.9%
4/58 • Approximately 3.25 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.2%
5/41 • Approximately 3.25 years
|
9.4%
3/32 • Approximately 3.25 years
|
7.4%
2/27 • Approximately 3.25 years
|
10.3%
6/58 • Approximately 3.25 years
|
|
Gastrointestinal disorders
Constipation
|
7.3%
3/41 • Approximately 3.25 years
|
28.1%
9/32 • Approximately 3.25 years
|
22.2%
6/27 • Approximately 3.25 years
|
22.4%
13/58 • Approximately 3.25 years
|
|
Gastrointestinal disorders
Diarrhoea
|
29.3%
12/41 • Approximately 3.25 years
|
25.0%
8/32 • Approximately 3.25 years
|
48.1%
13/27 • Approximately 3.25 years
|
48.3%
28/58 • Approximately 3.25 years
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
3.7%
1/27 • Approximately 3.25 years
|
6.9%
4/58 • Approximately 3.25 years
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/41 • Approximately 3.25 years
|
9.4%
3/32 • Approximately 3.25 years
|
0.00%
0/27 • Approximately 3.25 years
|
12.1%
7/58 • Approximately 3.25 years
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
7.4%
2/27 • Approximately 3.25 years
|
1.7%
1/58 • Approximately 3.25 years
|
|
Gastrointestinal disorders
Nausea
|
24.4%
10/41 • Approximately 3.25 years
|
46.9%
15/32 • Approximately 3.25 years
|
37.0%
10/27 • Approximately 3.25 years
|
29.3%
17/58 • Approximately 3.25 years
|
|
Gastrointestinal disorders
Vomiting
|
39.0%
16/41 • Approximately 3.25 years
|
53.1%
17/32 • Approximately 3.25 years
|
55.6%
15/27 • Approximately 3.25 years
|
41.4%
24/58 • Approximately 3.25 years
|
|
General disorders
Asthenia
|
48.8%
20/41 • Approximately 3.25 years
|
43.8%
14/32 • Approximately 3.25 years
|
63.0%
17/27 • Approximately 3.25 years
|
62.1%
36/58 • Approximately 3.25 years
|
|
General disorders
Mucosal inflammation
|
17.1%
7/41 • Approximately 3.25 years
|
28.1%
9/32 • Approximately 3.25 years
|
14.8%
4/27 • Approximately 3.25 years
|
19.0%
11/58 • Approximately 3.25 years
|
|
General disorders
Oedema
|
2.4%
1/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
7.4%
2/27 • Approximately 3.25 years
|
3.4%
2/58 • Approximately 3.25 years
|
|
General disorders
Oedema peripheral
|
2.4%
1/41 • Approximately 3.25 years
|
9.4%
3/32 • Approximately 3.25 years
|
7.4%
2/27 • Approximately 3.25 years
|
1.7%
1/58 • Approximately 3.25 years
|
|
General disorders
Pain
|
4.9%
2/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
3.7%
1/27 • Approximately 3.25 years
|
5.2%
3/58 • Approximately 3.25 years
|
|
General disorders
Pyrexia
|
7.3%
3/41 • Approximately 3.25 years
|
18.8%
6/32 • Approximately 3.25 years
|
11.1%
3/27 • Approximately 3.25 years
|
15.5%
9/58 • Approximately 3.25 years
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/41 • Approximately 3.25 years
|
6.2%
2/32 • Approximately 3.25 years
|
3.7%
1/27 • Approximately 3.25 years
|
5.2%
3/58 • Approximately 3.25 years
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
7.4%
2/27 • Approximately 3.25 years
|
0.00%
0/58 • Approximately 3.25 years
|
|
Infections and infestations
Pneumonia
|
0.00%
0/41 • Approximately 3.25 years
|
3.1%
1/32 • Approximately 3.25 years
|
7.4%
2/27 • Approximately 3.25 years
|
3.4%
2/58 • Approximately 3.25 years
|
|
Infections and infestations
Respiratory tract infection
|
2.4%
1/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
3.7%
1/27 • Approximately 3.25 years
|
5.2%
3/58 • Approximately 3.25 years
|
|
Infections and infestations
Urinary tract infection
|
2.4%
1/41 • Approximately 3.25 years
|
3.1%
1/32 • Approximately 3.25 years
|
3.7%
1/27 • Approximately 3.25 years
|
5.2%
3/58 • Approximately 3.25 years
|
|
Investigations
Weight decreased
|
2.4%
1/41 • Approximately 3.25 years
|
6.2%
2/32 • Approximately 3.25 years
|
0.00%
0/27 • Approximately 3.25 years
|
0.00%
0/58 • Approximately 3.25 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.6%
6/41 • Approximately 3.25 years
|
28.1%
9/32 • Approximately 3.25 years
|
29.6%
8/27 • Approximately 3.25 years
|
25.9%
15/58 • Approximately 3.25 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.4%
1/41 • Approximately 3.25 years
|
6.2%
2/32 • Approximately 3.25 years
|
3.7%
1/27 • Approximately 3.25 years
|
0.00%
0/58 • Approximately 3.25 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.3%
3/41 • Approximately 3.25 years
|
3.1%
1/32 • Approximately 3.25 years
|
7.4%
2/27 • Approximately 3.25 years
|
3.4%
2/58 • Approximately 3.25 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.9%
2/41 • Approximately 3.25 years
|
6.2%
2/32 • Approximately 3.25 years
|
7.4%
2/27 • Approximately 3.25 years
|
6.9%
4/58 • Approximately 3.25 years
|
|
Nervous system disorders
Dizziness
|
7.3%
3/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
18.5%
5/27 • Approximately 3.25 years
|
1.7%
1/58 • Approximately 3.25 years
|
|
Nervous system disorders
Dysaesthesia
|
2.4%
1/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
18.5%
5/27 • Approximately 3.25 years
|
0.00%
0/58 • Approximately 3.25 years
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/41 • Approximately 3.25 years
|
3.1%
1/32 • Approximately 3.25 years
|
7.4%
2/27 • Approximately 3.25 years
|
5.2%
3/58 • Approximately 3.25 years
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/41 • Approximately 3.25 years
|
3.1%
1/32 • Approximately 3.25 years
|
11.1%
3/27 • Approximately 3.25 years
|
12.1%
7/58 • Approximately 3.25 years
|
|
Nervous system disorders
Paraesthesia
|
2.4%
1/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
22.2%
6/27 • Approximately 3.25 years
|
13.8%
8/58 • Approximately 3.25 years
|
|
Psychiatric disorders
Insomnia
|
2.4%
1/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
3.7%
1/27 • Approximately 3.25 years
|
5.2%
3/58 • Approximately 3.25 years
|
|
Renal and urinary disorders
Renal failure
|
7.3%
3/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
0.00%
0/27 • Approximately 3.25 years
|
1.7%
1/58 • Approximately 3.25 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.4%
1/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
3.7%
1/27 • Approximately 3.25 years
|
5.2%
3/58 • Approximately 3.25 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.4%
1/41 • Approximately 3.25 years
|
6.2%
2/32 • Approximately 3.25 years
|
7.4%
2/27 • Approximately 3.25 years
|
3.4%
2/58 • Approximately 3.25 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/41 • Approximately 3.25 years
|
3.1%
1/32 • Approximately 3.25 years
|
3.7%
1/27 • Approximately 3.25 years
|
5.2%
3/58 • Approximately 3.25 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/41 • Approximately 3.25 years
|
46.9%
15/32 • Approximately 3.25 years
|
18.5%
5/27 • Approximately 3.25 years
|
24.1%
14/58 • Approximately 3.25 years
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
3.7%
1/27 • Approximately 3.25 years
|
6.9%
4/58 • Approximately 3.25 years
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
0.00%
0/41 • Approximately 3.25 years
|
6.2%
2/32 • Approximately 3.25 years
|
0.00%
0/27 • Approximately 3.25 years
|
3.4%
2/58 • Approximately 3.25 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
14.6%
6/41 • Approximately 3.25 years
|
28.1%
9/32 • Approximately 3.25 years
|
14.8%
4/27 • Approximately 3.25 years
|
19.0%
11/58 • Approximately 3.25 years
|
|
Vascular disorders
Deep vein thrombosis
|
2.4%
1/41 • Approximately 3.25 years
|
9.4%
3/32 • Approximately 3.25 years
|
0.00%
0/27 • Approximately 3.25 years
|
1.7%
1/58 • Approximately 3.25 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/41 • Approximately 3.25 years
|
0.00%
0/32 • Approximately 3.25 years
|
7.4%
2/27 • Approximately 3.25 years
|
0.00%
0/58 • Approximately 3.25 years
|
|
Vascular disorders
Phlebitis
|
0.00%
0/41 • Approximately 3.25 years
|
6.2%
2/32 • Approximately 3.25 years
|
0.00%
0/27 • Approximately 3.25 years
|
3.4%
2/58 • Approximately 3.25 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER