UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000245 |
|---|---|
| Receipt number | R000000304 |
| Scientific Title | Phase III Comparative Clinical Trial of Treatment Schedules for Oral UFT/LV Therapy as Postoperative Adjuvant Chemotherapy for Stage IIB/III Colorectal Cancer |
| Date of disclosure of the study information | 2005/09/22 |
| Last modified on | 2015/09/14 13:52:44 |
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Basic information
Public title
Phase III Comparative Clinical Trial of Treatment Schedules for Oral UFT/LV Therapy as Postoperative Adjuvant Chemotherapy for Stage IIB/III Colorectal Cancer
Acronym
Phase III Comparative Clinical Trial of Treatment Schedules for Oral UFT/LV Therapy as Postoperative Adjuvant Chemotherapy for Stage IIB/III Colorectal Cancer (JFMC33-0502)
Scientific Title
Phase III Comparative Clinical Trial of Treatment Schedules for Oral UFT/LV Therapy as Postoperative Adjuvant Chemotherapy for Stage IIB/III Colorectal Cancer
Scientific Title:Acronym
Phase III Comparative Clinical Trial of Treatment Schedules for Oral UFT/LV Therapy as Postoperative Adjuvant Chemotherapy for Stage IIB/III Colorectal Cancer (JFMC33-0502)
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the optimal treatment schedule for oral UFT/LV therapy as postoperative adjuvant chemotherapy for colorectal cancer, we will divide patients with Stage IIB/III colon and rectal cancer (only Rs) who have undergone curative surgery into two groups, a group treated with 5 courses (6 months), each consisting of 28 consecutive days of UFT/LV administration followed by 7 days off the drugs, and a group treated with 15 courses (18 months), each consisting of 5 weeks of 5 consecutive days of UFT/LV administration followed by 2 days off the drugs.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
disease-free survival
Key secondary outcomes
overall survival, incidence of adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group A (standard therapy group): Administration of 5 courses (6 months) of a schedule (consecutive administration method) in which one course consists of UFT (300 mg/m2/day) and LV (75 mg/day) for 28 consecutive days followed by 7 days off the drugs.
Interventions/Control_2
Group B (trial therapy group): Administration of 15 courses (18 months) of a schedule (5 days on, 2 days off: Saturday and Sunday) in which one course consists of 5 weeks of UFT (300 mg/m2/day) and LV (75 mg/day) for 5 consecutive days followed by 2 days off.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Histologically confirmed colorectal cancer
2) Histological Stage IIB, IIIA, IIIB, IIIC located in colon and rectosigmoid
3) Curative resection with D2 or more lymph node dissection
4) Resection of histological curability A was performed
5) Performance status (ECOG) 0, 1
6) No prior chemotherapy and radiotherapy
7) Oral intake is possible
8) Sufficient organ functions
a) WBC >= 3,000/mm3, <12,000/mm3
b) Neutrophil >=1,500/mm3
c) Hemoglobin >= 9.0g/dL
d) Platelet >= 100,000/mm3
e) Total bilirubin < 1.5mg/dL
f) AST, ALT < 100IU/L
g) Serum creatinine < 1.5mg/dL
9) Chemotherapy will be started within 6 weeks from operation
10) Written informed consent
Key exclusion criteria
1) active synchronous or metachronous malignancy other than carcinoma in situ
2) serious coexisting illness
a; severe pulmonary dysfunction
b; ileus or colon dysfunction
c; uncontrolled diabetes mellitus
d; liver cirrhosis
e; uncontrolled hypertension
f; history of myocardial infarction, unstable angina within 6 months prior to the registration
3) pregnant or nursing
4) severe mental disorders
5) not suitable for participating in the study for any other reason
Target sample size
840
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Susumu Kodaira |
Organization
Teikyo University
Division name
Visiting Professor
Zip code
Address
2-11-1, Kaga, Itabashi-ku, Tokyo, 173-8606, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Japanese Foundation for Multidisciplinary Treatment of Cancer |
Organization
Japanese Foundation for Multidisciplinary Treatment of Cancer
Division name
Office
Zip code
Address
TaniBuilding3F, 1-28-6, kameido, koutou-ku, Tokyo, 136-0071, Japan
TEL
03-5627-7594
Homepage URL
http://www.jfmc.or.jp/
jfmc-dc@jfmc.or.jp
Sponsor or person
Institute
Japanese Foundation for Multidisciplinary Treatment of Cancer
Institute
Department
Personal name
Funding Source
Organization
Japanese Foundation for Multidisciplinary Treatment of Cancer
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2005 | Year | 09 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://dx.doi.org/10.1093/annonc/mdv358
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2005 | Year | 07 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2005 | Year | 09 | Month | 21 | Day |
Last modified on
| 2015 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000304
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