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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001527
Receipt No. R000001843
Scientific Title Randomized Phase III Trial Comparing surgery-alone to UFT+PSK in Stage II Rectal Cancer
Date of disclosure of the study information 2009/01/01
Last modified on 2017/11/09

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Basic information
Public title Randomized Phase III Trial Comparing surgery-alone to UFT+PSK in Stage II Rectal Cancer
Acronym Randomized Phase III Trial Comparing surgery-alone to UFT+PSK in Stage II Rectal Cancer(JFMC38-0901)
Scientific Title Randomized Phase III Trial Comparing surgery-alone to UFT+PSK in Stage II Rectal Cancer
Scientific Title:Acronym Randomized Phase III Trial Comparing surgery-alone to UFT+PSK in Stage II Rectal Cancer(JFMC38-0901)
Region
Japan

Condition
Condition Rectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinical effectiveness of UFT-PSK combination as adjuvant therapy in comparison to surgery-alone for rectal cancer.
Enrolling patients : pTNM stage II (UICC version6) rectal cancer who have undergone surgery of remaining tumor R0.
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 1) Overall survival
2) Relation between Clinical Parameters and prognosis

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
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 Control group : surgery-alone
Interventions/Control_2 UFT : Administered orally 400 mg/day thrice daily after meal for 5 days and followed by 2 days rest (one cycle) for one year after surgery.
PSK:Administered orally 3 g/day thrice daily after meal for one year after surgery.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1)Stage II,Histologically confirmed adenocarcinoma of the rectum.
2)Patients with resection of a rectal cancer with D2 or more lymph node dissection.
3)pN0
4)Performance status:0-2
5)Patients without receiving chemotherapy, radiation exposure, rectum resection (remove the local operation), and the excision of the pelvis lymph node ,including the treatment for the other carcinoma.
6)Patients who have satisfied the following the latest clinical test values in two weeks or after operation and within two weeks before the registration.
1.WBC:>= 3,000/mm3, <12,000/mm3
2.Neutrophile:>= 1,500/mm3
3.Hemoglobin:>= 9.0g/dL
4.Platelet:>= 100,000/mm3
5.Total bilirubin:< 1.5 mg/dL
6.AST,ALT:<100IU/L
7.Serum creatinine:<1.5mg/dL
7)Patient with starting the chemotherapy within 8 weeks after operation.
8)Patients who have given consent to participate in this clinical study by himself/herself.
Key exclusion criteria 1)Ingestion impossibility or digestive organs stricture.
2)Serious coexisting illness.
3)Primary tumor in Proctos(P) or External skin (E).
4)Active synchronous or metachronous malignancy carcinoma in situ.
5)Pregnant or nursing.
6)Not suitable for participating in the study for any other reason.
Target sample size 540

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyotaka Okuno
Organization Kinki University School of Medicine
Division name Department of Surgery
Zip code
Address 377-2 Ohno-higashi, Osaka-sayama 589-8511, Japan
TEL
Email

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/
Email jfmc-dc@jfmc.or.jp

Sponsor
Institute Japanese Foundation for Multidisciplinary Treatment of Cancer
Institute
Department

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
Email

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
2009 Year 01 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://dx.doi.org/10.1007/s00280-017-3466-7
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
2008 Year 10 Month 04 Day
Date of IRB
Anticipated trial start date
2009 Year 01 Month 01 Day
Last follow-up date
2016 Year 12 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
2008 Year 11 Month 26 Day
Last modified on
2017 Year 11 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001843

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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