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Trial of Adjuvant Chemotherapy for Gastric Cancer

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.
 
ClinicalTrials.gov Identifier: NCT00296335
Recruitment Status : Completed
First Posted : February 27, 2006
Results First Posted : February 27, 2014
Last Update Posted : February 27, 2014
Sponsor:
Collaborators:
Ulsan University Hospital
Hallym University Medical Center
Information provided by (Responsible Party):
Yoon-Koo Kang, Asan Medical Center

Study Description
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Brief Summary:
This is a phase III randomized study designed to evaluate the efficacy of mitomycin, doxifluridine, and cisplatin compared to mitomycin and doxifluridine.

Condition or disease Intervention/treatment Phase
Stomach Cancer Drug: Mitomycin, doxifluridine and cisplatin Drug: Mitomycin and 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 mitomycin, cisplatin and prolonged treatment with doxifluridine compared to mitomycin plus doxifluridine.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 855 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 Advanced Gastric Adenocarcinoma
Study Start Date : February 2002
Actual Primary Completion Date : November 2007
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Mitomycin and doxifluridine
Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28-day 84)
 Drug: Mitomycin and doxifluridine
Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28-day 84)
Experimental: 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)
 Drug: 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)


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

    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.



Secondary Outcome Measures :
  1. Overall Survival Rate [ Time Frame: 3 years ]
    Overall survival rate at 3 years was defined as the proportion of patients who were alive at 3 years after surgery.

  2. Number of Patients With Adverse Events [ Time Frame: Up to 3 years ]
    Per National Cancer Institute Common Toxicity Criteria version 2.0, up to 3 years


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

Inclusion Criteria:

  • Pathologically proven gastric adenocarcinoma
  • 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: ECOG 0-2
  • Adequate bone marrow function (WBC ≥ 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, AST/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 CT
  • Systemic disease which interfere the administration of chemotherapy
  • Previous history of other malignancy except cured non-malignant skin cancer and uterine cervical cancer in situ
Contacts and Locations
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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): NCT00296335


Locations
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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
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Principal Investigator: Yoon-Koo Kang, M.D.,Ph.D. Asan Medical Center
More Information
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Responsible Party: Yoon-Koo Kang, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00296335    
Other Study ID Numbers: AMC-ONCGI-0204
First Posted: February 27, 2006    Key Record Dates
Results First Posted: February 27, 2014
Last Update Posted: February 27, 2014
Last Verified: January 2014
Keywords provided by Yoon-Koo Kang, Asan Medical Center:
Stomach cancer
Adjuvant chemotherapy
Mitomycin
Cisplatin
Doxifluridine
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Mitomycins
Mitomycin
Doxifluridine
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