Trial of Adjuvant Chemotherapy for Gastric Cancer
A Phase III Randomized Controlled Trial of Adjuvant Chemotherapy for Gastric Adenocarcinoma: Mitomycin and Doxifluridine Versus Intraperitoneal Chemotherapy and Mitomycin, Doxifluridine, and Cisplatin
1 other identifier
interventional
528
1 country
1
Brief Summary
This study is designed to evaluate the efficacy of the intraperitoneal chemotherapy with early mitomycin administration and adding cisplatin to prolonged treatment with doxifluridine compared to mitomycin plus doxifluridine in resected advanced gastric cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2001
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2001
CompletedFirst Submitted
Initial submission to the registry
February 24, 2006
CompletedFirst Posted
Study publicly available on registry
February 27, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedResults Posted
Study results publicly available
September 6, 2012
CompletedJanuary 18, 2020
January 1, 2020
6.2 years
February 24, 2006
July 19, 2012
January 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Relapse-free Survival
3 years
Secondary Outcomes (2)
Toxicity Profile (According to NCI CTC Version 2.0)
up to 1 year
Overall Survival
3 years
Study Arms (2)
Mitomycin-C, Doxifluridine
ACTIVE COMPARATORMf: 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)
Mitomycin-C, Doxifluridine, Cisplatin
ACTIVE COMPARATORiceMFP: Cisplatin 100mg with 1L of normal saline intraperitoneally for 2 hours during surgery Mitomycin-C 15mg/m2 intravenously (1 day after surgery) Doxifluridine 460-600mg/m2/day per oral(started at 4 weeks after surgery and administered a total of 12 months) Cisplatin 60mg/m2 intravenously monthly for 6 months (started at 4 weeks after surgery)
Interventions
Mf: 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: Cisplatin 100mg with 1L of normal saline intraperitoneally for 2 hours during surgery Mitomycin-C 15mg/m2 intravenously (1 day after surgery) Doxifluridine 460-600mg/m2/day per oral(started at 4 weeks after surgery and administered a total of 12 months) Cisplatin 60mg/m2 intravenously monthly for 6 months (started at 4 weeks after surgery)
Eligibility Criteria
You may qualify if:
- Pathologically proven gastric adenocarcinoma
- Grossly serosa invasion of primary tumor is suspicious
- Curative resection was done
- Stage II, IIIA, IIIB, IV (including T4, lesions or N3, but excluding M1 lymph node metastasis)
- Age: 18-69 years old
- Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2
- Adequate bone marrow function (white blood cell counts ≥ 4,000/ul, platelet count ≥ 100,000/ul, hemoglobin ≥ 10 g/dl)
- Adequate renal function (serum creatinine≤ 1.5)
- Adequate liver function (serum bilirubin ≤1.5 mg/dl, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 x normal upper limit)
- Written informed consent was signed by the patient
You may not qualify if:
- Previous chemotherapy or radiotherapy
- Active ongoing infection which antibiotic treatment is needed
- Pregnant or lactating women
- Psychosis or convulsion disorder
- Ascites in preoperative abdomen computed tomography (CT)
- Systemic disease which interfere the administration of chemotherapy
- Postoperative pathologic stage IA, IB
- Postoperative pathology indicates that resection margin is involved
- Previous history of other malignancy except cured non-malignant skin cancer and uterine cervical cancer in situ
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Asan Medical Centerlead
- Ulsan University Hospitalcollaborator
- Hallym University Medical Centercollaborator
Study Sites (1)
Asan Medical Center
Seoul, 138-736, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Yoon-Koo Kang
- Organization
- Asan Medical Center, University of Ulsan College of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Yoon-Koo Kang, M.D.,Ph.D.
Asan Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 24, 2006
First Posted
February 27, 2006
Study Start
October 1, 2001
Primary Completion
December 1, 2007
Study Completion
March 1, 2010
Last Updated
January 18, 2020
Results First Posted
September 6, 2012
Record last verified: 2020-01