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Randomized Phase III Study of 5-FU Continuous Infusion (5FUci) Versus MTX+5-FU Sequential Therapy (MF) in Gastric Cancer With Peritoneal Metastasis (JCOG0106-MF, MF/5FU)


Phase 3
20 Years
75 Years
Not Enrolling
Both
Gastric Cancer, Neoplasm Metastasis

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Trial Information

Randomized Phase III Study of 5-FU Continuous Infusion (5FUci) Versus MTX+5-FU Sequential Therapy (MF) in Gastric Cancer With Peritoneal Metastasis (JCOG0106-MF, MF/5FU)


Peritoneal metastasis is common in advanced gastric cancer and is considered an incurable
disease state. Peritoneal metastasis may cause serious complications, such as intestinal
obstruction, massive ascites, and hydronephrosis associated with the clinical presentation
of abdominal pain and fullness, vomiting, constipation, malnutrition and renal
dysfunction.5-FU continuous infusion remains the mainstay for chemotherapy against gastric
cancer. On the other, sequential MTX+5-FU was reported to be effective in advanced gastric
cancer with peritoneal metastasis in some phase II studies. Therefore, the randomized phase
III study of 5-FU versus sequential MTX+5-FU in gastric cancer with peritoneal metastasis
was conducted.


Inclusion Criteria:



1. histologic confirmation of gastric adenocarcinoma

2. inoperable metastatic disease or recurrent metastatic disease after surgery

3. disease with peritoneal metastasis

4. 20 years or more but less than 75 years

5. performance status 2 or less on the Eastern Cooperative Oncology Group scale

6. no prior treatment for gastric carcinoma except for surgery and adjuvant chemotherapy

7. no prior chemotherapy or radiotherapy for other disease except for gastric cancer

8. adequate bone marrow function, adequate liver function, and adequate renal function

9. no prior transfusion for anemia

10. provision of written informed consent

Exclusion Criteria:

1. Massive pleural effusion

2. brain metastasis with symptoms

3. severe diarrhea

4. other severe medical conditions (infection, diabetes, hypertension, acute myocardial
infarction, unstable angina, liver cirrhosis, intestinal pneumonia, pulmonary
fibrosis)

5. other active malignancies

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

overall survival

Principal Investigator

Kuniaki Shirao, MD,PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Gatrointestinal Oncology Division, National Cancer Center Hospital

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

JCOG0106-MF

NCT ID:

NCT00149201

Start Date:

November 2002

Completion Date:

April 2008

Related Keywords:

  • Gastric Cancer
  • Neoplasm Metastasis
  • gastric cancer
  • peritoneal metastasis
  • randomized trial
  • 5-FU
  • MTX
  • Neoplasms
  • Stomach Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary

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