Trial of Adjuvant Chemotherapy for Gastric Cancer

This study has been completed.
Sponsor:
Collaborators:
Ulsan University Hospital
Hallym University Medical Center
Information provided by (Responsible Party):
Yoon-Koo Kang, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00296335
First received: February 24, 2006
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Stomach Cancer
Drug: Mitomycin, doxifluridine and cisplatin
Drug: Mitomycin and doxifluridine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Randomized Controlled Trial of Adjuvant Chemotherapy for Advanced Gastric Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Relapse-free Survival Rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]

    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:
  • Overall Survival Rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Overall survival rate at 3 years was defined as the proportion of patients who were alive at 3 years after surgery.

  • Number of Patients With Adverse Events [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    Per National Cancer Institute Common Toxicity Criteria version 2.0, up to 3 years


Enrollment: 855
Study Start Date: February 2002
Study Completion Date: December 2009
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00296335

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
  More Information

No publications provided

Responsible Party: Yoon-Koo Kang, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00296335     History of Changes
Other Study ID Numbers: AMC-ONCGI-0204
Study First Received: February 24, 2006
Results First Received: November 12, 2013
Last Updated: January 13, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by 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
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing 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
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 22, 2014