Trial of Adjuvant Chemotherapy for Gastric Cancer - Full Text View

Sponsors and Collaborators:	Asan Medical Center Ulsan University Hospital Hallym University Medical Center
Information provided by:	Asan Medical Center
ClinicalTrials.gov Identifier:	NCT00296335

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, cisplatin, doxifluridine	Phase III

MedlinePlus related topics: Cancer Stomach Cancer

Drug Information available for: Cisplatin Mitomycin Mitomycins 5'-Deoxy-5-fluorouridine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Phase III Randomized Controlled Trial of Adjuvant Chemotherapy for Advanced Gastric Adenocarcinoma

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:

relapse free survival

Secondary Outcome Measures:

overall survival
toxicity

Estimated Enrollment:	882
Study Start Date:	February 2002

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, leions 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

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

Contacts

Contact: Yoon-Koo Kang, M.D.,Ph.D.

82-2-3010-3230

ykkang@amc.seoul.kr

Locations

Korea, Republic of
Asan Medical Center	Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Yoon-Koo Kang, M.D.,Ph.D. 82-2-3010-3230 ykkang@amc.seoul.kr
Principal Investigator: Yoon-Koo Kang, M.D.,Ph.D.

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

Study ID Numbers:	AMC-ONCGI-0204
Study First Received:	February 24, 2006
Last Updated:	February 24, 2006
ClinicalTrials.gov Identifier:	NCT00296335
Health Authority:	South Korea: Korean Food and Drug Administration

Keywords provided by Asan Medical Center:

Stomach cancer
Adjuvant chemotherapy
Mitomycin
Cisplatin
Doxifluridine

Study placed in the following topic categories:

Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms
Cisplatin
Gastrointestinal Diseases
Stomach Neoplasms

Doxifluridine
Mitomycin
Gastrointestinal Neoplasms
Stomach cancer
Adenocarcinoma
Mitomycins

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Central Nervous System Stimulants
Enzyme Inhibitors
Antibiotics, Antineoplastic
Immunosuppressive Agents

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Central Nervous System Agents
Alkylating Agents
Appetite Stimulants
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009