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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

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.

Condition or disease Intervention/treatment Phase
Stomach Cancer Drug: cisplatin, mitomycin-C, doxifluridine Phase 3

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 528 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Randomized Controlled Trial of Adjuvant Chemotherapy for Gastric Adenocarcinoma: Mitomycin and Doxifluridine Versus Intraperitoneal Chemotherapy and Mitomycin, Doxifluridine, and Cisplatin
Study Start Date : October 2001
Actual Primary Completion Date : December 2007
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

Arm Intervention/treatment
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)
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, 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)
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)




Primary Outcome Measures :
  1. Relapse-free Survival [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. 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.

  2. Overall Survival [ Time Frame: 3 years ]


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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00296322


Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Ulsan University Hospital
Hallym University Medical Center
Investigators
Principal Investigator: Yoon-Koo Kang, M.D.,Ph.D. Asan Medical Center

Responsible Party: Yoon-Koo Kang, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00296322     History of Changes
Other Study ID Numbers: AMC-ONCGI-0102
First Posted: February 27, 2006    Key Record Dates
Results First Posted: September 6, 2012
Last Update Posted: August 14, 2013
Last Verified: August 2013

Keywords provided by Yoon-Koo Kang, Asan Medical Center:
stomach cancer
adjuvant chemotherapy
mitomycin
cisplatin
doxifluridine

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Doxifluridine
Cisplatin
Mitomycins
Mitomycin
Floxuridine
Antineoplastic Agents
Antibiotics, Antineoplastic
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Antimetabolites, Antineoplastic
Antimetabolites
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Appetite Stimulants
Central Nervous System Stimulants