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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00296335
Other study ID # AMC-ONCGI-0204
Secondary ID
Status Completed
Phase Phase 3
First received February 24, 2006
Last updated January 13, 2014
Start date February 2002
Est. completion date December 2009

Study information

Verified date January 2014
Source Asan Medical Center
Contact n/a
Is FDA regulated No
Health authority South Korea: Korea Food and Drug Administration (KFDA)
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 855
Est. completion date December 2009
Est. primary completion date November 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 69 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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)
Mitomycin and doxifluridine
Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28-day 84)

Locations

Country Name City State
Korea, Republic of Asan Medical Center Seoul

Sponsors (3)

Lead Sponsor Collaborator
Asan Medical Center Hallym University Medical Center, Ulsan University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Relapse-free Survival Rate 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.
3 years No
Secondary Overall Survival Rate Overall survival rate at 3 years was defined as the proportion of patients who were alive at 3 years after surgery. 3 years No
Secondary Number of Patients With Adverse Events Per National Cancer Institute Common Toxicity Criteria version 2.0, up to 3 years Up to 3 years Yes
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