A Study of 5-FU Versus MTX+5-FU in Gastric Cancer With Peritoneal Metastasis
This study has been completed.
Sponsor:
Japan Clinical Oncology Group
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
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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) |
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:
- 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
Contacts and Locations
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:
|
Neoplasms Stomach Neoplasms Neoplasm Metastasis Neoplasms, Second Primary Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Neoplastic Processes |
Pathologic Processes Fluorouracil Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013