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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by:
Japan Clinical Oncology Group
ClinicalTrials.gov Identifier:
NCT00149201
First received: September 7, 2005
Last updated: February 2, 2009
Last verified: February 2009
  Purpose

To develop effective chemotherapy regimen against gastric cancer with peritoneal metastasis


Condition Intervention Phase
Gastric Cancer
Neoplasm Metastasis
Drug: 5-FU continuous infusion
Drug: MTX + 5-FU sequential therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Japan Clinical Oncology Group:

Primary Outcome Measures:
  • overall survival

Secondary Outcome Measures:
  • oral intake
  • toxicity

Estimated Enrollment: 160
Study Start Date: November 2002
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00149201

Locations
Japan
Aichi Cancer Center Hospital
1-1,Kanokoden,Chikusa-ku,Nagoya, Aichi, Japan, 464-8681
Aichi Cancer Center,Aichi Hospital
18,Kuriyado,Kake-machi,Okazaki, Aichi, Japan, 444-0011
Nagoya Medical Center
4-1-1,Sannomaru,Naka-ku,Nagoya, Aichi, Japan, 460-0001
Aomori Prefectural Central Hospital
2-1-1,Higashitsukurimiti,Aomori, Aomori, Japan, 030-0911
National Cancer Center Hospital East
6-5-1,Kashiwanoha,Kashiwa, Chiba, Japan, 277-8577
Chiba Cancer Center Hospital
666-2,Nitona-cho,Chuo-ku,Chiba, Chiba, Japan, 260-8717
Asahi General Hospital
I-1326,Asahi, Chiba, Japan, 289-2511
National Hospital Organization Shikoku Cancer Center
13,Horinouchi,Matsuyama, Ehime, Japan, 790-0007
Kyushu University Hospital
3-1-1,Maidashi,Higashi-ku, Fukuoka, Japan, 812-8582
National Kyushu Cancer Center
3-1-1,Notame,Minami-ku,Fukuoka, Fukuoka, Japan, 811-1395
Federation of national public service personnel mutual aid associations Tonan Hospital
kita 1 nishi 6,Chuo-ku,Sapporo, Hokkaido, Japan, 060-0001
Hokkaido University Hospital
North-14 West-5 Kita-ku,Sapporo, Hokkaido, Japan, 060-8648
Hyogo Medical Center for Adults
13-70,Kitaouji-cho,Akashi, Hyogo, Japan, 673-8558
Kobe University Graduate School of Medicine
7-5-2,Kusunoki-cho,Chuo-ku,Kobe, Hyogo, Japan, 650-0017
Ibaraki Kenritsu Chuo Hospital & Cancer Center
6528,Koibuchi,Tomobemachi,Nishi-ibarakigun, Ibaraki, Japan, 309-1793
Iwate Prefectural Central Hospital
1-4-1,Ueda,Morioka, Iwate, Japan, 020-0066
Kanagawa Cancer Center
1-1-2,Nakao,Asahi-ku,Yokohama, Kanagawa, Japan, 241-0815
Kitasato University East Hospital
2-1-1,Asamizodai,Sagamihara, Kanagawa, Japan, 228-8520
Yokohama City University Medical Center
4-57,Urafunecho,Minami-ku,Yokohama, Kanagawa, Japan, 232-0024
Yokohama Mucipical Citizen's Hospital
56,Okazawa-cho,Hodogaya-ku,Yokohama, Kanagawa, Japan, 240-8555
Kochi Health Science Center
2125-1,Ike,Kochi, Kochi, Japan, 781-8555
Kumamoto Regional Medical Center Hospital
5-16-10,Honjo,Kumamoto, Kumamoto, Japan, 860-0811
Kyoto University Hospital
54,Syogoinkawara,Sakyo-ku,Kyoto, Kyoto, Japan, 606-8507
Tohoku University Hospital
1-1,Seiryo-machi,Aoba-ku,Sendai, Miyagi, Japan, 980-0874
Saku Central Hospital
197,Usuda,Saku, Nagano, Japan, 384-0301
Osaka Medical College
2-7,Daigakucho,Takatsuki, Osaka, Japan, 569-0801
Saitama Medical School Hospital
38,Morohongo,Moroyama-machi,Iruma-gun, Saitama, Japan, 350-0495
Saitama Cancer Center
818,Komuro,Ina,Kita-adachi, Saitama, Japan, 362-0806
Sizuoka Cancer Center
1007,Shimonagakubo,Nagaizumi-cho,Sunto-gun, Shizuoka, Japan, 411-8777
Tochigi Cancer Center
4-9-13,Yohnan,Utsunomiya, Tochigi, Japan, 320-0834
Showa University School of Medicine
1-5-8,Hatanodai,Shinagawa-ku, Tokyo, Japan, 142-8666
Cancer Institute Hospital
3-10-6,Ariake,Koto-ku, Tokyo, Japan, 135-8550
National Cancer Center Hospital
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan, 104-0045
Yamagata Prefectural Central Hospital
1800,Aoyagi,Yamagata, Yamagata, Japan, 990-2292
Sponsors and Collaborators
Japan Clinical Oncology Group
Ministry of Health, Labour and Welfare, Japan
Investigators
Study Chair: Kuniaki Shirao, MD,PhD Gatrointestinal Oncology Division, National Cancer Center Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Japan Clinical Oncology Group
ClinicalTrials.gov Identifier: NCT00149201     History of Changes
Other Study ID Numbers: JCOG0106-MF, C000000123
Study First Received: September 7, 2005
Last Updated: February 2, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japan Clinical Oncology Group:
gastric cancer
peritoneal metastasis
randomized trial
5-FU
MTX

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Stomach Diseases

ClinicalTrials.gov processed this record on November 25, 2014