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Trial of Adjuvant Chemotherapy for Gastric Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00296322
First Posted: February 27, 2006
Last Update Posted: August 14, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Ulsan University Hospital
Hallym University Medical Center
Information provided by (Responsible Party):
Yoon-Koo Kang, Asan Medical Center
February 24, 2006
February 27, 2006
July 19, 2012
September 6, 2012
August 14, 2013
October 2001
December 2007   (Final data collection date for primary outcome measure)
Relapse-free Survival [ Time Frame: 3 years ]
Relapse-free Survival
Complete list of historical versions of study NCT00296322 on ClinicalTrials.gov Archive Site
  • Toxicity Profile (According to NCI CTC Version 2.0) [ Time Frame: up to 1 year ]
    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.
  • Overall Survival [ Time Frame: 3 years ]
  • overall survival
  • toxicity
Not Provided
Not Provided
 
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
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.

Stomach cancer is the most common cancer in Korea and one of the major health problems worldwide. The most effective treatment for gastric cancer is curative surgical resection of primary tumor. However, a substantial number of patients eventually die of recurrences after curative resection. A number of randomized trials investigating the role of adjuvant chemotherapy have been conducted. However, the efficacy of adjuvant chemotherapy is still controversial and varied between Western and Asian trials. Meta-analysis of Western trials didn't demonstrate the benefit of adjuvant chemotherapy after curative resection. Conversely, some Asian studies have demonstrated the efficacy of adjuvant chemotherapy after curative resection. In a previous study, mitomycin plus tegafur prolonged the survival in resected gastric cancer compared to no treatment.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Stomach Cancer
Drug: cisplatin, mitomycin-C, doxifluridine

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)

  • Active Comparator: Mitomycin-C, Doxifluridine
    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)
    Intervention: Drug: cisplatin, mitomycin-C, doxifluridine
  • Active Comparator: Mitomycin-C, Doxifluridine, Cisplatin
    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)
    Intervention: Drug: cisplatin, mitomycin-C, doxifluridine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
528
March 2010
December 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sexes Eligible for Study: All
18 Years to 69 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT00296322
AMC-ONCGI-0102
No
Not Provided
Not Provided
Yoon-Koo Kang, Asan Medical Center
Asan Medical Center
  • Ulsan University Hospital
  • Hallym University Medical Center
Principal Investigator: Yoon-Koo Kang, M.D.,Ph.D. Asan Medical Center
Asan Medical Center
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP