Colorectal NeoplasmsPhase 3NCT00190515
A Trial Comparing Adjuvant Oral UFT/LV to 5-FU/l-LV in Stage III Colorectal Cancer (JCOG-0205-MF)
A Phase 3 study testing 5FU+l-leucovorin and UFT+Leucovorin in people with Colorectal Neoplasms, run by Haruhiko Fukuda at 48 sites in Japan.
Trial summary
To evaluate the clinical effectiveness of oral UFT/LV comparing 5-FU/l-LV as adjuvant therapy for stage III colorectal cancer. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- 5FU+l-leucovorin and UFT+Leucovorin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,101 participants
- Where
- 48 sitesJapan
- Study dates
- Feb 2003to Nov 2011
- 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
- Pathologically proved colorectal cancer (either adenocarcinoma, mucinous carcinoma, or signet-ring cell carcinoma).
- Tumor is mainly located in between cecum and upper rectum, excluding that invades to lower rectum.
- Stage III cancer by General Rules for Clinical and Pathological Studies on Cancer of the Colon, Rectum and Anus (6th ed.), excluding si(ai), n(-), M(-).
- No synchronous colorectal cancer which invade muscularis propria or deeper.
- Tumor resection with D2 or D3 lymph node dissection was performed.
- Pathological determination of curability of tumor resection is cur A.
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- Age at registration is above 20 and below 75 years old.
- ECOG Performance status is 0 or 1.
- No prior chemotherapy or radiation therapy.
- Intake of normal diet and oral drugs is possible.
- Major organ function is preserved. WBC>=3,000/mcl, PLT>=100,000/mcl, GOT<=100 IU/L, GPT<=100 IU/L, T.Bil <=2.0 mg/dl, Cr<=1.5 mg/dl
- Adjuvant chemotherapy can be started within 9 weeks after surgery.
- Written informed consent is taken.
Who cannot join
- Active co-existing malignancy （synchronous or metachronous malignancy whose disease free period is within 5 years). Carcinoma in situ is eligible.
- Severe postoperative complications which do not resolve until registration.
- There is following complication. insulin-controlling or uncontrollable diabetes mellitus, uncontrollable hypertension, myocardial infarction within six month or unstable angina pectoris, liver cirrhosis, interstitial pneumonia, pulmonary fibrosis, severe emphysema
- Pregnant or breast-feeding woman.
- Difficult to participate with the trial, having mental disorder or psychiatric symptoms.
- Judged to be inappropriate to register.
Trial locations and contacts
48 sites in 1 country.
48 sites in 1 country
Japan48 sites
Kansai Rosai Hospital
Amagasaki,Inabasou,3-1-69, Hyōgo, 660-8511
Tokyo Medical and Dental University Hospital
Bunkyo-ku,Yushima,1-5-45, Tokyo, 113-8519
Chiba Cancer Center Hospital
Chiba,Chuo-ku,Nitona-cho,666-2, Chiba, 260-8717
National Cancer Center Hospital
Chuo-ku, Tsukiji, 5-1-1, Tokyo, 104-0045
National Kyushu Cancer Center
Fukuoka,Minami-ku,Notame,3-1-1, Fukuoka, 811-1395
Hiroshima University, School of Medicine
Hiroshima,Minami-ku,Kasumi,1-2-3, Hiroshima, 734-8551
Hiroshima City Hospital
Hiroshima,Naka-ku,Motomachi,7-33, Hiroshima, 730-8518
Ishikawa Prefectual Central Hospital
Kanazawa,Kuratsuki-Higashi,2-1, Ishikawa-ken, 920-8530
National Cancer Center Hospital East
Kashiwa,Kashiwanoha,6-5-1, Chiba, 277-8577
Teikyo University Hospital, Mizonokuchi
Kawasaki,Takatsu-ku,Mizonokuchi,3-8-3, Kanagawa, 213-8507
Kurume University School of Medicine
Kurume,Asahi-machi,67, Fukuoka, 830-0011
Kurume University Medical Center
Kurume,Kokubumachi,155-1, Fukuoka, 839-0863
National Hospital Organization Kyoto Medical Center
Kyoto,Fushimi-ku,Fukakusa,Mukaihata-cho,1-1, Kyoto, 612-8555
National Hospital Organization Shikoku Cancer Center
Matsuyama,Horinouchi,13, Ehime, 790-0007
Toho University Ohashi Hospital
Meguro-ku,Ohashi,2-17-6, Tokyo, 153-0044
Toranomon Hospital
Minato-ku,Toranomon,2-2-2, Tokyo, 105-8470
Minoh City Hospital
Minoh,Kayano,5-7-1, Osaka, 562-8562
Kyorin University School of Medicine
Mitaka,Shinkawa,6-20-2, Tokyo, 181-8611
Nagano Municipal Hospital
Nagano,Tomitake,1333-1, Nagano, 381-8551
Aichi Cancer Center Hospital
Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi-ken, 464-8681
Miyagi Cancer Center
Natori,Medeshima-Shiode,Nodayama,47-1, Miyagi, 981-1293
Niigata Cancer Center Hospital
Niigata,Kawagishi-cho,2-15-3, Niigata, 951-8566
Ibaraki Kenritsu Chuo Hospital & Cancer Center
Nishi-ibarakigun,Tomobemachi,Koibuchi,6528, Ibaraki, 309-1793
Sapporo-Kosei General Hospital
North-3,East8-5,Chuou-ku,Sapporo, Hokkaido, 060-0033
Oita University Fuculty of Medicine
Oita,Hasama-machi,Oogaoka,1-1, Oita Prefecture, 879-5593
Okayama Saiseikai General Hospital
Okayama,Ifukucho,1-17-18, Okayama-ken, 700-8511
Osaka National Hospital
Osaka,Chuo-ku,Hoenzaka,2-1-14, Osaka, 540-0006
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, 537-8511
Osaka City General Hospital
Osaka,Miyakojima-ku,Miyakojimahondori,2-13-22, Osaka, 534-0021
Gunma Prefectural Cancer Center
Ota,Takabayashi-nishi-cho,617-1, Gunma, 373-8550
Kitasato University East Hospital
Sagamihara,Asamizodai,2-1-1, Kanagawa, 228-8520
Kitasato University School of Medichine
Sagamihara,Kitasato,1-15-1, Kanagawa, 228-8555
Omiya Medical Center, Jichi Medical School
Saitama,Omiya-ku,Amanuma-cho,1-847, Saitama, 330-8503
Sakai Municipal Hospital
Sakai,Minamiyasuicho,1-1-1, Osaka, 590-0064
Toho University Sakura Hospital
Sakura,Shimoshidu,564-1, Chiba, 285-8741
Tokyo Medical University
Shinjuku-ku,Nishi-shinjuku,6-7-1, Tokyo, 160-0023
Keio University Hospital
Shinjuku-ku,Shinanomachi,35, Tokyo, 160-8582
Osaka University Graduate School of Medicine
Suita,Yamada-oka,2-2, Osaka, 565-0871
Sizuoka Cancer Center
Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007, Shizuoka, 411-8777
Osaka Medical College
Takatsuki,Daigakucho,2-7, Osaka, 569-0801
National Defense Medical College
Tokorozawa,Namiki,3-2, Saitama, 359-8513
Fujita Health University
Toyoake,Kutsukake-cho,Dengakugakubo,1-98, Aichi-ken, 470-1192
Jyuntendo Urayasu Hospital
Urayasu,Tomioka,2-1-1, Chiba, 279-0021
Tochigi Cancer Center
Utsunomiya,Yohnan,4-9-13, Tochigi, 320-0834
Yamagata Prefectural Central Hospital
Yamagata,Aoyagi,1800, Yamagata, 990-2292
Yokohama City University Medical Center
Yokohama,Minami-ku,Urafunecho,4-57, Kanagawa, 232-0024
Kanagawa Cancer Center
Yokohama,Nakao,Asahi-ku,1-1-2, Kanagawa, 241-0815
Showa University Northern Yokohama Hospital
Yokohama,Tsuzuki-ku,Chigasakichuo,35-1, Kanagawa, 224-8503
About this study
Official title: Randomized Phase III Trial Comparing Adjuvant Oral UFT/LV to 5-FU/l-LV in Stage III Colorectal Cancer (JCOG-0205-MF)
To evaluate the clinical effectiveness of oral UFT/LV comparing 5-FU/l-LV as adjuvant therapy for stage III colorectal cancer.
Read the detailed description
Oral fluoropyrimidines are widely used in practice for postoperative adjuvant chemotherapy for curatively resected colorectal cancer in Japan. In order to evaluate a clinical benefit of oral anticancer drugs in adjuvant chemotherapy, we conducted randomized controlled trial comparing the oral combination chemotherapy, UFT+LV, to the standard intravenous combination chemotherapy, 5-FU+l-LV, in stage III colorectal cancer.
UFT+LV: UFT 300mg/m2/day and LV 75mg/day, orally for 28days with 7days rest, repeated five times every 5 weeks.
5-FU+l-LV: 5-FU 500mg/m2, l-LV 250mg/m2, weekly administration for 6 times, repeated three times every 8 weeks.
Primary endpoints are disease-free survival and secondary endpoints are overall survival and adverse event rate.
- Conditions
- Colorectal Neoplasms
- Being tested
- 5FU+l-leucovorin, UFT+Leucovorin
- Keywords
- adjuvant chemotherapy, Stage III colorectal cancer, 5-FU+l-LV, UFT+LV, randomized controlled trial
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5FU+l-leucovorinDrug
5FU+l-leucovorin
UFT+LeucovorinDrug
UFT+Leucovorin
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 5-FU/l-LV Receives: Drug: 5FU+l-leucovorin |
| 2 | Experimental | UFT/LV Receives: Drug: UFT+Leucovorin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
Measured: during the study conduct
Secondary outcomes (2)
Overall survival
Measured: during the study conduct
Rate of adverse event
Measured: during the study conduct
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startFeb 2003
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies 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
- 1,101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haruhiko Fukuda
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Labour and Welfare, Japan
- Responsible party
- Sponsor-investigator, Haruhiko Fukuda, Japan Clinical Oncology Group
- Investigators
- Yoshihiro Moriya, MD, Study chair, National Cancer Center Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00190515
- Sponsor's protocol ID
- JCOG-0205-MF
- Other IDs
- C000000193
- Status last verified
- Sep 2016
- First submitted
- 12 Sep 2005
- Last updated
- 22 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase III Trial Comparing Adjuvant Oral UFT/LV to 5-FU/l-LV in Stage III Colorectal Cancer (JCOG-0205-MF)
- ClinicalTrials.gov ID
- NCT00190515
- Acronym / sponsor ID
- JCOG-0205-MF
- Conditions
- Colorectal Neoplasms
- Keywords
- adjuvant chemotherapy, Stage III colorectal cancer, 5-FU+l-LV, UFT+LV, randomized controlled trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,101 participants (actual)
- Lead sponsor
- Haruhiko FukudaUniversity, hospital or other
- Collaborators
- Ministry of Health, Labour and Welfare, Japan
- Study start
- Feb 2003
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 19 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 evaluate the clinical effectiveness of oral UFT/LV comparing 5-FU/l-LV as adjuvant therapy for stage III colorectal cancer.
Detailed description
Oral fluoropyrimidines are widely used in practice for postoperative adjuvant chemotherapy for curatively resected colorectal cancer in Japan. In order to evaluate a clinical benefit of oral anticancer drugs in adjuvant chemotherapy, we conducted randomized controlled trial comparing the oral combination chemotherapy, UFT+LV, to the standard intravenous combination chemotherapy, 5-FU+l-LV, in stage III colorectal cancer.
UFT+LV: UFT 300mg/m2/day and LV 75mg/day, orally for 28days with 7days rest, repeated five times every 5 weeks.
5-FU+l-LV: 5-FU 500mg/m2, l-LV 250mg/m2, weekly administration for 6 times, repeated three times every 8 weeks.
Primary endpoints are disease-free survival and secondary endpoints are overall survival and adverse event rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: 5FU+l-leucovorin5-FU/l-LV |
| 2 | Experimental | Drug: UFT+LeucovorinUFT/LV |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Pathologically proved colorectal cancer (either adenocarcinoma, mucinous carcinoma, or signet-ring cell carcinoma).
- Tumor is mainly located in between cecum and upper rectum, excluding that invades to lower rectum.
- Stage III cancer by General Rules for Clinical and Pathological Studies on Cancer of the Colon, Rectum and Anus (6th ed.), excluding si(ai), n(-), M(-).
- No synchronous colorectal cancer which invade muscularis propria or deeper.
- Tumor resection with D2 or D3 lymph node dissection was performed.
Key exclusion criteria (6 listed)
- Active co-existing malignancy （synchronous or metachronous malignancy whose disease free period is within 5 years). Carcinoma in situ is eligible.
- Severe postoperative complications which do not resolve until registration.
- There is following complication. insulin-controlling or uncontrollable diabetes mellitus, uncontrollable hypertension, myocardial infarction within six month or unstable angina pectoris, liver cirrhosis, interstitial pneumonia, pulmonary fibrosis, severe emphysema
- Pregnant or breast-feeding woman.
- Difficult to participate with the trial, having mental disorder or psychiatric symptoms.
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 |
|---|---|---|
| 5FU+l-leucovorin5FU+l-leucovorin | Drug | 1 |
| UFT+LeucovorinUFT+Leucovorin | Drug | 2 |
Primary outcome
Disease-free survival
Time frame: during the study conduct
2 secondary outcomes
Overall survival
Time frame: during the study conduct
Rate of adverse event
Time frame: during the study conduct
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 22 Sep 2016.
- 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.
Yoshihiro Moriya, MD study chair
National Cancer Center Hospital
48 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 5FU+l-leucovorin and UFT+Leucovorin in people with Colorectal Neoplasms, run by Haruhiko Fukuda at 48 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 13 inclusion and 6 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 22 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 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?
Disease-free survival (time frame: during the study conduct). 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 22 Sep 2016.