Trial Outcomes & Findings for Trial of Adjuvant Chemotherapy for Gastric Cancer (NCT NCT00296335)
NCT ID: NCT00296335
Last Updated: 2014-02-27
Results Overview
Relapse-free survival at 3 years was defined as the proportion of patients who did not show an evidence of disease recurrence after 3 years of surgery. Relapse was defined as any new tumor lesion.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
855 participants
Primary outcome timeframe
3 years
Results posted on
2014-02-27
Participant Flow
AMC0201 was an open-label, prospective randomised phase 3 clinical trial conducted at three centres (Asan medical center, Hallym University medical center, and Ulsan university hospital) in Korea. Patients were enrolled between February 2002 and August 2006
All enrolled patients received study treatments
Participant milestones
| Measure |
Mitomycin and Doxifluridine
Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28-day 84)
|
Mitomycin, Doxifluridine and Cisplatin
Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168)
|
|---|---|---|
|
Overall Study
STARTED
|
424
|
431
|
|
Overall Study
COMPLETED
|
394
|
309
|
|
Overall Study
NOT COMPLETED
|
30
|
122
|
Reasons for withdrawal
| Measure |
Mitomycin and Doxifluridine
Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28-day 84)
|
Mitomycin, Doxifluridine and Cisplatin
Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168)
|
|---|---|---|
|
Overall Study
Recurrence
|
3
|
51
|
|
Overall Study
Adverse Event
|
17
|
27
|
|
Overall Study
Lost to Follow-up
|
7
|
33
|
|
Overall Study
Physician Decision
|
3
|
11
|
Baseline Characteristics
Trial of Adjuvant Chemotherapy for Gastric Cancer
Baseline characteristics by cohort
| Measure |
Mitomycin and Doxifluridine
n=424 Participants
Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168)
|
Mitomycin, Doxifluridine and Cisplatin
n=431 Participants
Experimental armMitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168)
|
Total
n=855 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
361 Participants
n=99 Participants
|
380 Participants
n=107 Participants
|
741 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
63 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
114 Participants
n=206 Participants
|
|
Age, Continuous
|
53.3 years
STANDARD_DEVIATION 10.6 • n=99 Participants
|
53.3 years
STANDARD_DEVIATION 10.1 • n=107 Participants
|
53.3 years
STANDARD_DEVIATION 10.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
130 Participants
n=99 Participants
|
137 Participants
n=107 Participants
|
267 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
294 Participants
n=99 Participants
|
294 Participants
n=107 Participants
|
588 Participants
n=206 Participants
|
|
Region of Enrollment
Korea, Republic of
|
424 participants
n=99 Participants
|
431 participants
n=107 Participants
|
855 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: Intention-to treat population
Relapse-free survival at 3 years was defined as the proportion of patients who did not show an evidence of disease recurrence after 3 years of surgery. Relapse was defined as any new tumor lesion.
Outcome measures
| Measure |
Mitomycin Plus Short-term Fluoropyrimidine
n=424 Participants
Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28-day 84)
|
Mitomycin Plus Long-term Fluoropyrimidine and Monthly Cisplati
n=431 Participants
Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168)
|
|---|---|---|
|
Relapse-free Survival Rate
|
67.0 percentage of participants
Interval 62.5 to 71.5
|
64.9 percentage of participants
Interval 60.4 to 69.4
|
SECONDARY outcome
Timeframe: 3 yearsOverall survival rate at 3 years was defined as the proportion of patients who were alive at 3 years after surgery.
Outcome measures
| Measure |
Mitomycin Plus Short-term Fluoropyrimidine
n=424 Participants
Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28-day 84)
|
Mitomycin Plus Long-term Fluoropyrimidine and Monthly Cisplati
n=431 Participants
Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168)
|
|---|---|---|
|
Overall Survival Rate
|
76.9 percentage of participants
Interval 72.9 to 80.9
|
73.1 percentage of participants
Interval 68.9 to 77.3
|
SECONDARY outcome
Timeframe: Up to 3 yearsPer National Cancer Institute Common Toxicity Criteria version 2.0, up to 3 years
Outcome measures
| Measure |
Mitomycin Plus Short-term Fluoropyrimidine
n=422 Participants
Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28-day 84)
|
Mitomycin Plus Long-term Fluoropyrimidine and Monthly Cisplati
n=425 Participants
Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168)
|
|---|---|---|
|
Number of Patients With Adverse Events
Neutropenia
|
262 participants
|
387 participants
|
|
Number of Patients With Adverse Events
Anemia
|
393 participants
|
413 participants
|
|
Number of Patients With Adverse Events
Thrombocytopenia
|
101 participants
|
156 participants
|
|
Number of Patients With Adverse Events
Fatigue
|
343 participants
|
391 participants
|
|
Number of Patients With Adverse Events
Diarrhea
|
219 participants
|
288 participants
|
|
Number of Patients With Adverse Events
Nausea
|
293 participants
|
371 participants
|
|
Number of Patients With Adverse Events
Vomiting
|
104 participants
|
160 participants
|
Adverse Events
Mitomycin Plus Short-term Fluoropyrimidine
Serious events: 3 serious events
Other events: 393 other events
Deaths: 0 deaths
Mitomycin Plus Long-term Fluoropyrimidine and Monthly Cisplati
Serious events: 5 serious events
Other events: 413 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mitomycin Plus Short-term Fluoropyrimidine
n=422 participants at risk
Control arm
|
Mitomycin Plus Long-term Fluoropyrimidine and Monthly Cisplati
n=425 participants at risk
Experimental arm
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
0.24%
1/422
|
0.71%
3/425
|
|
Gastrointestinal disorders
Vomiting
|
0.47%
2/422
|
0.47%
2/425
|
Other adverse events
| Measure |
Mitomycin Plus Short-term Fluoropyrimidine
n=422 participants at risk
Control arm
|
Mitomycin Plus Long-term Fluoropyrimidine and Monthly Cisplati
n=425 participants at risk
Experimental arm
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
62.1%
262/422
|
91.1%
387/425
|
|
Blood and lymphatic system disorders
Anemia
|
93.1%
393/422
|
97.2%
413/425
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
23.9%
101/422
|
36.7%
156/425
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
27.0%
114/422
|
38.1%
162/425
|
|
General disorders
Fatigue
|
81.3%
343/422
|
92.0%
391/425
|
|
General disorders
Anorexia
|
77.3%
326/422
|
91.5%
389/425
|
|
Gastrointestinal disorders
Nausea
|
69.4%
293/422
|
87.3%
371/425
|
|
Gastrointestinal disorders
Vomiting
|
24.6%
104/422
|
37.6%
160/425
|
|
Gastrointestinal disorders
Stomatitis
|
18.2%
77/422
|
35.5%
151/425
|
|
Gastrointestinal disorders
Diarrhea
|
51.9%
219/422
|
67.8%
288/425
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
61.8%
261/422
|
78.6%
334/425
|
|
Nervous system disorders
Neuropathy
|
35.3%
149/422
|
70.8%
301/425
|
|
Skin and subcutaneous tissue disorders
Hand-foot syndrome
|
8.3%
35/422
|
17.2%
73/425
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.8%
109/422
|
39.3%
167/425
|
|
Musculoskeletal and connective tissue disorders
Edema
|
10.4%
44/422
|
25.4%
108/425
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place