A Study of 5-FU Versus MTX+5-FU in Gastric Cancer With Peritoneal Metastasis

Gastric Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00149201
• Other study ID #: JCOG0106-MF
• Secondary ID: C000000123
• Status: Completed
• Phase: Phase 3
• First received: September 7, 2005
• Last updated: February 2, 2009
• Start date: November 2002
• Est. completion date: April 2008

Study information

• Verified date: February 2009
• Source: Japan Clinical Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

To develop effective chemotherapy regimen against gastric cancer with peritoneal metastasis

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Gastric Cancer
• Neoplasm Metastasis
• Stomach Neoplasms

Intervention

Drug:
• 5-FU continuous infusion

• MTX + 5-FU sequential therapy

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Japan Clinical Oncology Group	Ministry of Health, Labour and Welfare, Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival
Secondary	oral intake
Secondary	toxicity

External Links

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