Trial Outcomes & Findings for Trial of Adjuvant Chemotherapy for Gastric Cancer (NCT NCT00296322)
NCT ID: NCT00296322
Last Updated: 2020-01-18
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
528 participants
Primary outcome timeframe
3 years
Results posted on
2020-01-18
Participant Flow
Although this study was originally designed to include 528 patients, a total 521 patients could be enrolled.
Participant milestones
| Measure |
Mitomycin and Short-term Fluoropyrimidine
Mitomycin-C 20mg/m2 intravenously (3-6 weeks after surgery) Doxifluridine 460-600mg/m2/day per oral for 3 months (started 4 weeks after surgery)
|
iceMFP
Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine
|
|---|---|---|
|
Overall Study
STARTED
|
258
|
263
|
|
Overall Study
COMPLETED
|
237
|
184
|
|
Overall Study
NOT COMPLETED
|
21
|
79
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Adjuvant Chemotherapy for Gastric Cancer
Baseline characteristics by cohort
| Measure |
Mitomycin and Short-term Fluoropyrimidine
n=258 Participants
Mitomycin-C 20mg/m2 intravenously (3-6 weeks after surgery) Doxifluridine 460-600mg/m2/day per oral for 3 months (started 4 weeks after surgery)
|
iceMFP
n=263 Participants
Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine
|
Total
n=521 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
212 Participants
n=93 Participants
|
224 Participants
n=4 Participants
|
436 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
46 Participants
n=93 Participants
|
39 Participants
n=4 Participants
|
85 Participants
n=27 Participants
|
|
Age, Continuous
|
53.87 years
STANDARD_DEVIATION 10.093 • n=93 Participants
|
52.23 years
STANDARD_DEVIATION 11.016 • n=4 Participants
|
53.04 years
STANDARD_DEVIATION 10.591 • n=27 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=93 Participants
|
88 Participants
n=4 Participants
|
170 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
176 Participants
n=93 Participants
|
175 Participants
n=4 Participants
|
351 Participants
n=27 Participants
|
|
Region of Enrollment
Korea, Republic of
|
258 participants
n=93 Participants
|
263 participants
n=4 Participants
|
521 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 3 yearsOutcome measures
| Measure |
Mitomycin and Short-term Fluoropyrimidine
n=258 Participants
Mitomycin and short-term flouropyrimidine
|
iceMFP
n=263 Participants
Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine
|
|---|---|---|
|
Relapse-free Survival
|
50.0 percentage of participants
Interval 43.4 to 56.6
|
60.2 percentage of participants
Interval 53.6 to 66.7
|
SECONDARY outcome
Timeframe: up to 1 yearBecause safety profile in oncology study is evaluated for each toxicity, it is impossible to present the overall patient number. Instead, we presented the number of patients who declined study therapy due to adverse events or patient will.
Outcome measures
| Measure |
Mitomycin and Short-term Fluoropyrimidine
n=258 Participants
Mitomycin and short-term flouropyrimidine
|
iceMFP
n=263 Participants
Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine
|
|---|---|---|
|
Toxicity Profile (According to NCI CTC Version 2.0)
|
13 participants
|
30 participants
|
SECONDARY outcome
Timeframe: 3 yearsOutcome measures
| Measure |
Mitomycin and Short-term Fluoropyrimidine
n=258 Participants
Mitomycin and short-term flouropyrimidine
|
iceMFP
n=263 Participants
Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine
|
|---|---|---|
|
Overall Survival
|
59.6 percentage of participants
Interval 52.9 to 66.3
|
71.2 percentage of participants
Interval 65.1 to 77.3
|
Adverse Events
Mitomycin and Short-term Fluoropyrimidine
Serious events: 0 serious events
Other events: 230 other events
Deaths: 0 deaths
iceMFP
Serious events: 0 serious events
Other events: 251 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Mitomycin and Short-term Fluoropyrimidine
n=258 participants at risk
Mitomycin-C 20mg/m2 intravenously (3-6 weeks after surgery) Doxifluridine 460-600mg/m2/day per oral for 3 months (started 4 weeks after surgery)
|
iceMFP
n=263 participants at risk
Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
62.4%
161/258
|
82.5%
217/263
|
|
Blood and lymphatic system disorders
Anemia
|
89.1%
230/258
|
90.5%
238/263
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
18.2%
47/258
|
23.6%
62/263
|
|
Hepatobiliary disorders
Elevated AST or ALT
|
31.8%
82/258
|
22.8%
60/263
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
28.3%
73/258
|
31.6%
83/263
|
|
General disorders
Fatigue
|
83.3%
215/258
|
89.7%
236/263
|
|
General disorders
Anorexia
|
78.7%
203/258
|
88.2%
232/263
|
|
Gastrointestinal disorders
Nausea
|
72.5%
187/258
|
85.9%
226/263
|
|
Gastrointestinal disorders
Vomiting
|
28.3%
73/258
|
47.9%
126/263
|
|
Gastrointestinal disorders
Stomatitis
|
21.3%
55/258
|
43.3%
114/263
|
|
Gastrointestinal disorders
Constipation
|
32.9%
85/258
|
62.4%
164/263
|
|
Gastrointestinal disorders
Diarrhea
|
65.1%
168/258
|
73.4%
193/263
|
|
General disorders
Alopecia
|
53.9%
139/258
|
80.6%
212/263
|
|
Nervous system disorders
Neuropathy
|
17.8%
46/258
|
62.7%
165/263
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.9%
54/258
|
34.6%
91/263
|
|
Musculoskeletal and connective tissue disorders
Edema
|
7.8%
20/258
|
28.1%
74/263
|
Additional Information
Dr. Yoon-Koo Kang
Asan Medical Center, University of Ulsan College of Medicine
Phone: +82-2-3010-3230
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place