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A Phase III Randomized Controlled Trial of Adjuvant Chemotherapy for Gastric Adenocarcinoma: Mitomycin and Doxifluridine Versus Intraperitoneal Chemotherapy and Mitomycin, Doxifluridine, and Cisplatin


Phase 3
18 Years
69 Years
Not Enrolling
Both
Stomach Cancer

Thank you

Trial Information

A Phase III Randomized Controlled Trial of Adjuvant Chemotherapy for Gastric Adenocarcinoma: Mitomycin and Doxifluridine Versus Intraperitoneal Chemotherapy and Mitomycin, Doxifluridine, and Cisplatin


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.


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

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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Relapse-free Survival

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

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

Investigator Role:

Principal Investigator

Investigator Affiliation:

Asan Medical Center

Authority:

South Korea: Korea Food and Drug Administration (KFDA)

Study ID:

AMC-ONCGI-0102

NCT ID:

NCT00296322

Start Date:

October 2001

Completion Date:

March 2010

Related Keywords:

  • Stomach Cancer
  • stomach cancer
  • adjuvant chemotherapy
  • mitomycin
  • cisplatin
  • doxifluridine
  • Stomach Neoplasms

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