Trial of Adjuvant Chemotherapy for Gastric Cancer

Stomach Cancer Clinical Trial

Official title:

A Phase III Randomized Controlled Trial of Adjuvant Chemotherapy for Advanced Gastric Adenocarcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00296335
• Other study ID #: AMC-ONCGI-0204
• 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

• Stomach Cancer
• Stomach Neoplasms

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