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Trial of Adjuvant Chemotherapy for Gastric Cancer

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ClinicalTrials.gov Identifier: NCT00296322
Recruitment Status : Completed
First Posted : February 27, 2006
Results First Posted : September 6, 2012
Last Update Posted : August 14, 2013
Sponsor:
Collaborators:
Ulsan University Hospital
Hallym University Medical Center
Information provided by (Responsible Party):
Yoon-Koo Kang, Asan Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Stomach Cancer
Intervention Drug: cisplatin, mitomycin-C, doxifluridine
Enrollment 528

Recruitment Details  
Pre-assignment Details Although this study was originally designed to include 528 patients, a total 521 patients could be enrolled.
Arm/Group Title Mitomycin and Short-term Fluoropyrimidine iceMFP
Hide Arm/Group Description 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) Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine
Period Title: Overall Study
Started 258 263
Completed 237 184
Not Completed 21 79
Arm/Group Title Mitomycin and Short-term Fluoropyrimidine iceMFP Total
Hide Arm/Group Description 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) Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine Total of all reporting groups
Overall Number of Baseline Participants 258 263 521
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 258 participants 263 participants 521 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
212
  82.2%
224
  85.2%
436
  83.7%
>=65 years
46
  17.8%
39
  14.8%
85
  16.3%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 258 participants 263 participants 521 participants
53.87  (10.093) 52.23  (11.016) 53.04  (10.591)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 258 participants 263 participants 521 participants
Female
82
  31.8%
88
  33.5%
170
  32.6%
Male
176
  68.2%
175
  66.5%
351
  67.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 258 participants 263 participants 521 participants
258 263 521
1.Primary Outcome
Title Relapse-free Survival
Hide Description [Not Specified]
Time Frame 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mitomycin and Short-term Fluoropyrimidine iceMFP
Hide Arm/Group Description:
Mitomycin and short-term flouropyrimidine
Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine
Overall Number of Participants Analyzed 258 263
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
50.0
(43.4 to 56.6)
60.2
(53.6 to 66.7)
2.Secondary Outcome
Title Toxicity Profile (According to NCI CTC Version 2.0)
Hide Description Because 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.
Time Frame up to 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mitomycin and Short-term Fluoropyrimidine iceMFP
Hide Arm/Group Description:
Mitomycin and short-term flouropyrimidine
Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine
Overall Number of Participants Analyzed 258 263
Measure Type: Number
Unit of Measure: participants
13 30
3.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mitomycin and Short-term Fluoropyrimidine iceMFP
Hide Arm/Group Description:
Mitomycin and short-term flouropyrimidine
Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine
Overall Number of Participants Analyzed 258 263
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
59.6
(52.9 to 66.3)
71.2
(65.1 to 77.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mitomycin and Short-term Fluoropyrimidine iceMFP
Hide Arm/Group Description 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) Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine
All-Cause Mortality
Mitomycin and Short-term Fluoropyrimidine iceMFP
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Mitomycin and Short-term Fluoropyrimidine iceMFP
Affected / at Risk (%) Affected / at Risk (%)
Total   0/258 (0.00%)   0/263 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Mitomycin and Short-term Fluoropyrimidine iceMFP
Affected / at Risk (%) Affected / at Risk (%)
Total   230/258 (89.15%)   251/263 (95.44%) 
Blood and lymphatic system disorders     
Neutropenia  161/258 (62.40%)  217/263 (82.51%) 
Anemia  230/258 (89.15%)  238/263 (90.49%) 
Thrombocytopenia   47/258 (18.22%)  62/263 (23.57%) 
Gastrointestinal disorders     
Nausea  187/258 (72.48%)  226/263 (85.93%) 
Vomiting  73/258 (28.29%)  126/263 (47.91%) 
Stomatitis  55/258 (21.32%)  114/263 (43.35%) 
Constipation  85/258 (32.95%)  164/263 (62.36%) 
Diarrhea  168/258 (65.12%)  193/263 (73.38%) 
General disorders     
Fatigue  215/258 (83.33%)  236/263 (89.73%) 
Anorexia  203/258 (78.68%)  232/263 (88.21%) 
Alopecia  139/258 (53.88%)  212/263 (80.61%) 
Hepatobiliary disorders     
Elevated AST or ALT  82/258 (31.78%)  60/263 (22.81%) 
Hyperbilirubinemia  73/258 (28.29%)  83/263 (31.56%) 
Musculoskeletal and connective tissue disorders     
Myalgia  54/258 (20.93%)  91/263 (34.60%) 
Edema  20/258 (7.75%)  74/263 (28.14%) 
Nervous system disorders     
Neuropathy  46/258 (17.83%)  165/263 (62.74%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Yoon-Koo Kang
Organization: Asan Medical Center, University of Ulsan College of Medicine
Phone: +82-2-3010-3230
Responsible Party: Yoon-Koo Kang, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00296322     History of Changes
Other Study ID Numbers: AMC-ONCGI-0102
First Submitted: February 24, 2006
First Posted: February 27, 2006
Results First Submitted: July 19, 2012
Results First Posted: September 6, 2012
Last Update Posted: August 14, 2013