Clinical trial NCT00149201: A Study of 5-FU Versus MTX+5-FU in Gastric Cancer With Peritoneal Metastasis
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Cancer
Neoplasm Metastasis
Keywords: gastric cancer
peritoneal metastasis
randomized trial
5-FU
MTX
Lead sponsor: Japan Clinical Oncology Group
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Labour and Welfare, Japan
First posted: 2005-09-08
Enrollment: 160
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To develop effective chemotherapy regimen against gastric cancer with peritoneal metastasis

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: overall survival
Secondary outcomes:
measure: oral intake
measure: toxicity
Other outcomes:
Locations:
city: 1-1,Kanokoden,Chikusa-ku,Nagoya
country: Japan
facility: Aichi Cancer Center Hospital
state: Aichi
city: 18,Kuriyado,Kake-machi,Okazaki
country: Japan
facility: Aichi Cancer Center,Aichi Hospital
state: Aichi
city: 4-1-1,Sannomaru,Naka-ku,Nagoya
country: Japan
facility: Nagoya Medical Center
state: Aichi
city: 2-1-1,Higashitsukurimiti,Aomori
country: Japan
facility: Aomori Prefectural Central Hospital
state: Aomori
city: 6-5-1,Kashiwanoha,Kashiwa
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: 666-2,Nitona-cho,Chuo-ku,Chiba
country: Japan
facility: Chiba Cancer Center Hospital
state: Chiba
city: I-1326,Asahi
country: Japan
facility: Asahi General Hospital
state: Chiba
city: 13,Horinouchi,Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
state: Ehime
city: 3-1-1,Maidashi,Higashi-ku
country: Japan
facility: Kyushu University Hospital
state: Fukuoka
city: 3-1-1,Notame,Minami-ku,Fukuoka
country: Japan
facility: National Kyushu Cancer Center
state: Fukuoka
city: kita 1 nishi 6,Chuo-ku,Sapporo
country: Japan
facility: Federation of national public service personnel mutual aid associations Tonan Hospital
state: Hokkaido
city: North-14 West-5 Kita-ku,Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: 13-70,Kitaouji-cho,Akashi
country: Japan
facility: Hyogo Medical Center for Adults
state: Hyogo
city: 7-5-2,Kusunoki-cho,Chuo-ku,Kobe
country: Japan
facility: Kobe University Graduate School of Medicine
state: Hyogo
city: 6528,Koibuchi,Tomobemachi,Nishi-ibarakigun
country: Japan
facility: Ibaraki Kenritsu Chuo Hospital & Cancer Center
state: Ibaraki
city: 1-4-1,Ueda,Morioka
country: Japan
facility: Iwate Prefectural Central Hospital
state: Iwate
city: 1-1-2,Nakao,Asahi-ku,Yokohama
country: Japan
facility: Kanagawa Cancer Center
state: Kanagawa
city: 2-1-1,Asamizodai,Sagamihara
country: Japan
facility: Kitasato University East Hospital
state: Kanagawa
city: 4-57,Urafunecho,Minami-ku,Yokohama
country: Japan
facility: Yokohama City University Medical Center
state: Kanagawa
city: 56,Okazawa-cho,Hodogaya-ku,Yokohama
country: Japan
facility: Yokohama Mucipical Citizen's Hospital
state: Kanagawa
city: 2125-1,Ike,Kochi
country: Japan
facility: Kochi Health Science Center
state: Kochi
city: 5-16-10,Honjo,Kumamoto
country: Japan
facility: Kumamoto Regional Medical Center Hospital
state: Kumamoto
city: 54,Syogoinkawara,Sakyo-ku,Kyoto
country: Japan
facility: Kyoto University Hospital
state: Kyoto
city: 1-1,Seiryo-machi,Aoba-ku,Sendai
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: 197,Usuda,Saku
country: Japan
facility: Saku Central Hospital
state: Nagano
city: 2-7,Daigakucho,Takatsuki
country: Japan
facility: Osaka Medical College
state: Osaka
city: 38,Morohongo,Moroyama-machi,Iruma-gun
country: Japan
facility: Saitama Medical School Hospital
state: Saitama
city: 818,Komuro,Ina,Kita-adachi
country: Japan
facility: Saitama Cancer Center
state: Saitama
city: 1007,Shimonagakubo,Nagaizumi-cho,Sunto-gun
country: Japan
facility: Sizuoka Cancer Center
state: Shizuoka
city: 4-9-13,Yohnan,Utsunomiya
country: Japan
facility: Tochigi Cancer Center
state: Tochigi
city: 1-5-8,Hatanodai,Shinagawa-ku
country: Japan
facility: Showa University School of Medicine
state: Tokyo
city: 3-10-6,Ariake,Koto-ku
country: Japan
facility: Cancer Institute Hospital
state: Tokyo
city: 5-1-1 Tsukiji, Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: 1800,Aoyagi,Yamagata
country: Japan
facility: Yamagata Prefectural Central Hospital
state: Yamagata
Study officials:
affiliation: Gatrointestinal Oncology Division, National Cancer Center Hospital
name: Kuniaki Shirao, MD,PhD
role: STUDY_CHAIR
References: