Gastric CancerPhase 3NCT00149201
A Study of 5-FU Versus MTX+5-FU in Gastric Cancer With Peritoneal Metastasis
A Phase 3 study testing 5-FU continuous infusion and MTX + 5-FU sequential therapy in people with Gastric Cancer and Neoplasm Metastasis, run by Japan Clinical Oncology Group at 34 sites in Japan.
Trial summary
To develop effective chemotherapy regimen against gastric cancer with peritoneal metastasis Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Gastric Cancer, Neoplasm Metastasis
- What is being tested?
- 5-FU continuous infusion and MTX + 5-FU sequential therapy
- Type of treatment
- Injection or infusion
- How many people
- 160 participants
- Where
- 34 sitesJapan
- Study dates
- Nov 2002to Apr 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
Japan34 sites
Kanagawa Cancer Center
1-1-2,Nakao,Asahi-ku,Yokohama, Kanagawa, 241-0815
Aichi Cancer Center Hospital
1-1,Kanokoden,Chikusa-ku,Nagoya, Aichi-ken, 464-8681
Tohoku University Hospital
1-1,Seiryo-machi,Aoba-ku,Sendai, Miyagi, 980-0874
Iwate Prefectural Central Hospital
1-4-1,Ueda,Morioka, Iwate, 020-0066
Showa University School of Medicine
1-5-8,Hatanodai,Shinagawa-ku, Tokyo, 142-8666
Sizuoka Cancer Center
1007,Shimonagakubo,Nagaizumi-cho,Sunto-gun, Shizuoka, 411-8777
Hyogo Medical Center for Adults
13-70,Kitaouji-cho,Akashi, Hyōgo, 673-8558
National Hospital Organization Shikoku Cancer Center
13,Horinouchi,Matsuyama, Ehime, 790-0007
Aichi Cancer Center,Aichi Hospital
18,Kuriyado,Kake-machi,Okazaki, Aichi-ken, 444-0011
Yamagata Prefectural Central Hospital
1800,Aoyagi,Yamagata, Yamagata, 990-2292
Saku Central Hospital
197,Usuda,Saku, Nagano, 384-0301
Kitasato University East Hospital
2-1-1,Asamizodai,Sagamihara, Kanagawa, 228-8520
Aomori Prefectural Central Hospital
2-1-1,Higashitsukurimiti,Aomori, Aomori, 030-0911
Osaka Medical College
2-7,Daigakucho,Takatsuki, Osaka, 569-0801
Kochi Health Science Center
2125-1,Ike,Kochi, Kochi, 781-8555
Kyushu University Hospital
3-1-1,Maidashi,Higashi-ku, Fukuoka, 812-8582
National Kyushu Cancer Center
3-1-1,Notame,Minami-ku,Fukuoka, Fukuoka, 811-1395
Cancer Institute Hospital
3-10-6,Ariake,Koto-ku, Tokyo, 135-8550
Saitama Medical School Hospital
38,Morohongo,Moroyama-machi,Iruma-gun, Saitama, 350-0495
Nagoya Medical Center
4-1-1,Sannomaru,Naka-ku,Nagoya, Aichi-ken, 460-0001
Yokohama City University Medical Center
4-57,Urafunecho,Minami-ku,Yokohama, Kanagawa, 232-0024
Tochigi Cancer Center
4-9-13,Yohnan,Utsunomiya, Tochigi, 320-0834
National Cancer Center Hospital
5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045
Kumamoto Regional Medical Center Hospital
5-16-10,Honjo,Kumamoto, Kumamoto, 860-0811
Kyoto University Hospital
54,Syogoinkawara,Sakyo-ku,Kyoto, Kyoto, 606-8507
Yokohama Mucipical Citizen's Hospital
56,Okazawa-cho,Hodogaya-ku,Yokohama, Kanagawa, 240-8555
National Cancer Center Hospital East
6-5-1,Kashiwanoha,Kashiwa, Chiba, 277-8577
Ibaraki Kenritsu Chuo Hospital & Cancer Center
6528,Koibuchi,Tomobemachi,Nishi-ibarakigun, Ibaraki, 309-1793
Chiba Cancer Center Hospital
666-2,Nitona-cho,Chuo-ku,Chiba, Chiba, 260-8717
Kobe University Graduate School of Medicine
7-5-2,Kusunoki-cho,Chuo-ku,Kobe, Hyōgo, 650-0017
Saitama Cancer Center
818,Komuro,Ina,Kita-adachi, Saitama, 362-0806
Asahi General Hospital
I-1326,Asahi, Chiba, 289-2511
Federation of national public service personnel mutual aid associations Tonan Hospital
Kita 1 Nishi 6,Chuo-ku,Sapporo, Hokkaido, 060-0001
Hokkaido University Hospital
North-14 West-5 Kita-ku,Sapporo, Hokkaido, 060-8648
About this study
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)
To develop effective chemotherapy regimen against gastric cancer with peritoneal metastasis
Read the 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.
- Conditions
- Gastric Cancer, Neoplasm Metastasis
- Being tested
- 5-FU continuous infusion, MTX + 5-FU sequential therapy
- Keywords
- gastric cancer, peritoneal metastasis, randomized trial, 5-FU, MTX
- Medical subject headings
- Stomach Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-FU continuous infusionDrug
MTX + 5-FU sequential therapyDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Secondary outcomes (2)
oral intake
toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startNov 2002
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants
Sponsor and investigators
- Lead sponsor
- Japan Clinical Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Labour and Welfare, Japan
- Investigators
- Kuniaki Shirao, MD,PhD, Study chair, Gatrointestinal Oncology Division, National Cancer Center Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00149201
- Sponsor's protocol ID
- JCOG0106-MF
- Other IDs
- C000000123
- Status last verified
- Feb 2009
- First submitted
- 7 Sep 2005
- Last updated
- 3 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00149201
- Acronym / sponsor ID
- JCOG0106-MF
- Conditions
- Gastric Cancer, Neoplasm Metastasis
- Keywords
- gastric cancer, peritoneal metastasis, randomized trial, 5-FU, MTX
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants
- Lead sponsor
- Japan Clinical Oncology GroupUniversity, hospital or other
- Collaborators
- Ministry of Health, Labour and Welfare, Japan
- Study start
- Nov 2002
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 8 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5-FU continuous infusion | Drug | – |
| MTX + 5-FU sequential therapy | Drug | – |
Primary outcome
overall survival
2 secondary outcomes
oral intake
toxicity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2009.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kuniaki Shirao, MD,PhD study chair
Gatrointestinal Oncology Division, National Cancer Center Hospital
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 5-FU continuous infusion and MTX + 5-FU sequential therapy in people with Gastric Cancer and Neoplasm Metastasis, run by Japan Clinical Oncology Group at 34 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2009.