Trial of Adjuvant Chemotherapy for Gastric Cancer

Phase 3

Completed

• Conditions: Stomach Cancer
• Interventions: Drug: cisplatin, mitomycin-C, doxifluridine

• Registration Number: NCT00296322
• Lead Sponsor: Asan Medical Center

Brief Summary

This study is designed to evaluate the efficacy of the intraperitoneal chemotherapy with early mitomycin administration and adding cisplatin to prolonged treatment with doxifluridine compared to mitomycin plus doxifluridine in resected advanced gastric cancer.

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 the intraperitoneal chemotherapy with early mitomycin administration and adding cisplatin to prolonged treatment with doxifluridine compared to mitomycin plus doxifluridine.

Study Timeline

• Study Start: 2001-10
• Study First Submitted: 2006-02-24
• Study First Submitted QC: 2006-02-24
• Study First Posted: 2006-02-27
• Primary Completion: 2007-12
• Study Completion: 2010-03
• Results First Submitted: 2012-07-19
• Results First Submitted QC: 2012-08-01
• Results First Posted: 2012-09-06
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-06
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 528

Inclusion Criteria

• Pathologically proven gastric adenocarcinoma
• Grossly serosa invasion of primary tumor is suspicious
• 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: Eastern Cooperative Oncology Group (ECOG) 0-2
• Adequate bone marrow function (white blood cell counts ≥ 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, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 x normal upper limit)
• Written informed consent was signed by the patient

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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 computed tomography (CT)
• Systemic disease which interfere the administration of chemotherapy
• Postoperative pathologic stage IA, IB
• Postoperative pathology indicates that resection margin is involved
• Previous history of other malignancy except cured non-malignant skin cancer and uterine cervical cancer in situ

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mitomycin-C, Doxifluridine, Cisplatin	cisplatin, mitomycin-C, doxifluridine	iceMFP: Cisplatin 100mg with 1L of normal saline intraperitoneally for 2 hours during surgery Mitomycin-C 15mg/m2 intravenously (1 day after surgery) Doxifluridine 460-600mg/m2/day per oral(started at 4 weeks after surgery and administered a total of 12 months) Cisplatin 60mg/m2 intravenously monthly for 6 months (started at 4 weeks after surgery)
Mitomycin-C, Doxifluridine	cisplatin, mitomycin-C, doxifluridine	Mf: Mitomycin-C 20mg/m2 intravenously (3-6 weeks after surgery) Doxifluridine 460-600mg/m2/day per oral for 3 months (started 4 weeks after surgery)

Primary Outcome Measures

Name	Time	Method
Relapse-free Survival	3 years

Secondary Outcome Measures

Name	Time	Method
Toxicity Profile (According to NCI CTC Version 2.0)	up to 1 year	Because safety profile in oncology study is evaluated for each toxicity, it is impossible to present the overall patient number. Instead, we presented the number of patients who declined study therapy due to adverse events or patient will.
Overall Survival	3 years

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of