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

Primary Purpose

Gastric Cancer, Neoplasm Metastasis

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
5-FU continuous infusion
MTX + 5-FU sequential therapy
Sponsored by
Japan Clinical Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring gastric cancer, peritoneal metastasis, randomized trial, 5-FU, MTX

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: histologic confirmation of gastric adenocarcinoma inoperable metastatic disease or recurrent metastatic disease after surgery disease with peritoneal metastasis 20 years or more but less than 75 years performance status 2 or less on the Eastern Cooperative Oncology Group scale no prior treatment for gastric carcinoma except for surgery and adjuvant chemotherapy no prior chemotherapy or radiotherapy for other disease except for gastric cancer adequate bone marrow function, adequate liver function, and adequate renal function no prior transfusion for anemia provision of written informed consent Exclusion Criteria: Massive pleural effusion brain metastasis with symptoms severe diarrhea other severe medical conditions (infection, diabetes, hypertension, acute myocardial infarction, unstable angina, liver cirrhosis, intestinal pneumonia, pulmonary fibrosis) other active malignancies

Sites / Locations

  • Aichi Cancer Center Hospital
  • Aichi Cancer Center,Aichi Hospital
  • Nagoya Medical Center
  • Aomori Prefectural Central Hospital
  • National Cancer Center Hospital East
  • Chiba Cancer Center Hospital
  • Asahi General Hospital
  • National Hospital Organization Shikoku Cancer Center
  • Kyushu University Hospital
  • National Kyushu Cancer Center
  • Federation of national public service personnel mutual aid associations Tonan Hospital
  • Hokkaido University Hospital
  • Hyogo Medical Center for Adults
  • Kobe University Graduate School of Medicine
  • Ibaraki Kenritsu Chuo Hospital & Cancer Center
  • Iwate Prefectural Central Hospital
  • Kanagawa Cancer Center
  • Kitasato University East Hospital
  • Yokohama City University Medical Center
  • Yokohama Mucipical Citizen's Hospital
  • Kochi Health Science Center
  • Kumamoto Regional Medical Center Hospital
  • Kyoto University Hospital
  • Tohoku University Hospital
  • Saku Central Hospital
  • Osaka Medical College
  • Saitama Medical School Hospital
  • Saitama Cancer Center
  • Sizuoka Cancer Center
  • Tochigi Cancer Center
  • Showa University School of Medicine
  • Cancer Institute Hospital
  • National Cancer Center Hospital
  • Yamagata Prefectural Central Hospital

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

oral intake
toxicity

Full Information

First Posted
September 7, 2005
Last Updated
February 2, 2009
Sponsor
Japan Clinical Oncology Group
Collaborators
Ministry of Health, Labour and Welfare, Japan
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1. Study Identification

Unique Protocol Identification Number
NCT00149201
Brief Title
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

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Japan Clinical Oncology Group
Collaborators
Ministry of Health, Labour and Welfare, Japan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Neoplasm Metastasis
Keywords
gastric cancer, peritoneal metastasis, randomized trial, 5-FU, MTX

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
5-FU continuous infusion
Intervention Type
Drug
Intervention Name(s)
MTX + 5-FU sequential therapy
Primary Outcome Measure Information:
Title
overall survival
Secondary Outcome Measure Information:
Title
oral intake
Title
toxicity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: histologic confirmation of gastric adenocarcinoma inoperable metastatic disease or recurrent metastatic disease after surgery disease with peritoneal metastasis 20 years or more but less than 75 years performance status 2 or less on the Eastern Cooperative Oncology Group scale no prior treatment for gastric carcinoma except for surgery and adjuvant chemotherapy no prior chemotherapy or radiotherapy for other disease except for gastric cancer adequate bone marrow function, adequate liver function, and adequate renal function no prior transfusion for anemia provision of written informed consent Exclusion Criteria: Massive pleural effusion brain metastasis with symptoms severe diarrhea other severe medical conditions (infection, diabetes, hypertension, acute myocardial infarction, unstable angina, liver cirrhosis, intestinal pneumonia, pulmonary fibrosis) other active malignancies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kuniaki Shirao, MD,PhD
Organizational Affiliation
Gatrointestinal Oncology Division, National Cancer Center Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Aichi Cancer Center Hospital
City
1-1,Kanokoden,Chikusa-ku,Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Aichi Cancer Center,Aichi Hospital
City
18,Kuriyado,Kake-machi,Okazaki
State/Province
Aichi
ZIP/Postal Code
444-0011
Country
Japan
Facility Name
Nagoya Medical Center
City
4-1-1,Sannomaru,Naka-ku,Nagoya
State/Province
Aichi
ZIP/Postal Code
460-0001
Country
Japan
Facility Name
Aomori Prefectural Central Hospital
City
2-1-1,Higashitsukurimiti,Aomori
State/Province
Aomori
ZIP/Postal Code
030-0911
Country
Japan
Facility Name
National Cancer Center Hospital East
City
6-5-1,Kashiwanoha,Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Chiba Cancer Center Hospital
City
666-2,Nitona-cho,Chuo-ku,Chiba
State/Province
Chiba
ZIP/Postal Code
260-8717
Country
Japan
Facility Name
Asahi General Hospital
City
I-1326,Asahi
State/Province
Chiba
ZIP/Postal Code
289-2511
Country
Japan
Facility Name
National Hospital Organization Shikoku Cancer Center
City
13,Horinouchi,Matsuyama
State/Province
Ehime
ZIP/Postal Code
790-0007
Country
Japan
Facility Name
Kyushu University Hospital
City
3-1-1,Maidashi,Higashi-ku
State/Province
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
National Kyushu Cancer Center
City
3-1-1,Notame,Minami-ku,Fukuoka
State/Province
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Federation of national public service personnel mutual aid associations Tonan Hospital
City
kita 1 nishi 6,Chuo-ku,Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0001
Country
Japan
Facility Name
Hokkaido University Hospital
City
North-14 West-5 Kita-ku,Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Hyogo Medical Center for Adults
City
13-70,Kitaouji-cho,Akashi
State/Province
Hyogo
ZIP/Postal Code
673-8558
Country
Japan
Facility Name
Kobe University Graduate School of Medicine
City
7-5-2,Kusunoki-cho,Chuo-ku,Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
Ibaraki Kenritsu Chuo Hospital & Cancer Center
City
6528,Koibuchi,Tomobemachi,Nishi-ibarakigun
State/Province
Ibaraki
ZIP/Postal Code
309-1793
Country
Japan
Facility Name
Iwate Prefectural Central Hospital
City
1-4-1,Ueda,Morioka
State/Province
Iwate
ZIP/Postal Code
020-0066
Country
Japan
Facility Name
Kanagawa Cancer Center
City
1-1-2,Nakao,Asahi-ku,Yokohama
State/Province
Kanagawa
ZIP/Postal Code
241-0815
Country
Japan
Facility Name
Kitasato University East Hospital
City
2-1-1,Asamizodai,Sagamihara
State/Province
Kanagawa
ZIP/Postal Code
228-8520
Country
Japan
Facility Name
Yokohama City University Medical Center
City
4-57,Urafunecho,Minami-ku,Yokohama
State/Province
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Facility Name
Yokohama Mucipical Citizen's Hospital
City
56,Okazawa-cho,Hodogaya-ku,Yokohama
State/Province
Kanagawa
ZIP/Postal Code
240-8555
Country
Japan
Facility Name
Kochi Health Science Center
City
2125-1,Ike,Kochi
State/Province
Kochi
ZIP/Postal Code
781-8555
Country
Japan
Facility Name
Kumamoto Regional Medical Center Hospital
City
5-16-10,Honjo,Kumamoto
State/Province
Kumamoto
ZIP/Postal Code
860-0811
Country
Japan
Facility Name
Kyoto University Hospital
City
54,Syogoinkawara,Sakyo-ku,Kyoto
State/Province
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
Tohoku University Hospital
City
1-1,Seiryo-machi,Aoba-ku,Sendai
State/Province
Miyagi
ZIP/Postal Code
980-0874
Country
Japan
Facility Name
Saku Central Hospital
City
197,Usuda,Saku
State/Province
Nagano
ZIP/Postal Code
384-0301
Country
Japan
Facility Name
Osaka Medical College
City
2-7,Daigakucho,Takatsuki
State/Province
Osaka
ZIP/Postal Code
569-0801
Country
Japan
Facility Name
Saitama Medical School Hospital
City
38,Morohongo,Moroyama-machi,Iruma-gun
State/Province
Saitama
ZIP/Postal Code
350-0495
Country
Japan
Facility Name
Saitama Cancer Center
City
818,Komuro,Ina,Kita-adachi
State/Province
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
Sizuoka Cancer Center
City
1007,Shimonagakubo,Nagaizumi-cho,Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
Tochigi Cancer Center
City
4-9-13,Yohnan,Utsunomiya
State/Province
Tochigi
ZIP/Postal Code
320-0834
Country
Japan
Facility Name
Showa University School of Medicine
City
1-5-8,Hatanodai,Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
142-8666
Country
Japan
Facility Name
Cancer Institute Hospital
City
3-10-6,Ariake,Koto-ku
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
National Cancer Center Hospital
City
5-1-1 Tsukiji, Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Yamagata Prefectural Central Hospital
City
1800,Aoyagi,Yamagata
State/Province
Yamagata
ZIP/Postal Code
990-2292
Country
Japan

12. IPD Sharing Statement

Links:
URL
http://www.jcog.jp/
Description
Related Info

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

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