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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005427
Receipt No. R000005434
Scientific Title Clinical trial of adjuvant chemotherapy with mFOLFOX6 (L-OHP+l-LV/5-FU)/XELOX(L-OHP+Capecitabine)after curative resection for stage III colon cancer
Date of disclosure of the study information 2011/04/12
Last modified on 2017/04/13

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Basic information
Public title Clinical trial of adjuvant chemotherapy with mFOLFOX6 (L-OHP+l-LV/5-FU)/XELOX(L-OHP+Capecitabine)after curative resection for stage III colon cancer
Acronym FACOS
Scientific Title Clinical trial of adjuvant chemotherapy with mFOLFOX6 (L-OHP+l-LV/5-FU)/XELOX(L-OHP+Capecitabine)after curative resection for stage III colon cancer
Scientific Title:Acronym FACOS
Region
Japan

Condition
Condition Colon cancer
Classification by specialty
Surgery in general Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the efficacy and safety of mFOLFOX6/XELOX regimen for patients with curatively resected stage III colon cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes 3-year disease-free survival
Key secondary outcomes Safety
2-year disease-free survival
5-year median survival

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Gene
Interventions/Control_1 mFOLFOX6(L-OHP:85mg/m2, l-LV:200mg/m2, 5FU:400mg/m2 (bolus), 5FU:2,400mg/m2 (civ)).
Cycles of chemotherapy are given every 2 weeks for 6 months.
XELOX(Capecitabine:2000mg/m2,Oxaliplatin:130mg/m2).
Cycles of chemotherapy are given every 2 weeks for 6 months.
Interventions/Control_2
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.Stage III colon and rectosigmoid cancer.
2.Colectomy with D2<= Lymph node dissection.
3.Resection of histological curability A was performed.
4.20-75 years old.
5.Performance Status(ECOG):0 or 1
6.Without prior anti-tumor therapy (chemotherapy and radiotherapy).
7.Adequate functions of bone marrow, liver and renal as belowes:
WBC>= 4,000/mm3 to =<12,000mm3.
Neutrophil >= 2,000/m m3.
Platlet is >= 100,000/m m3.
Hemoglobin >= 9.0g/dL.
AST and ALT =< 100IU/L.
Creatinine is within normal limits.
8.Able to start therapy between 4 and 8 weeks after surgery.
9.Written Informed Consent.
Key exclusion criteria 1.Synchronous multiple cancer and metachronous multiple cancer within 5-years.
2.Severe postoperative complications
,such as infection, ruptured suture, gastrointestinal bleeding.
3.Sensory peripheral neuropathy.
4.Uncontrolled hypertension.
5.Uncontrolled Diabetes Mellitus.
6.Marked abnormality of ECG, or clinically important cardiac disorders such as congestive heart failure, symptomatic coronary artery disease, uncontrolled arrythmia,history of cardiac infarction within 12 months.

7.Severe pulmonary complications, such as interstitial pneumonitis, pulmonary fibrosis, pulmonary emphysema.
8.With Evidence or history of psychiatric disability and central neurological disorder.
9.Diarrhea.
10.Systemic continuous administration of steroid drugs(p.o. or i.v.).
11.Pregnant, woman of child-bearing potential or lactating woman.
12.Not appropriate for the study at the physician's assessment.
Target sample size 130

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideyuki Ishida
Organization Saitama Medical Center,Saitama Medical University
Division name Department of digestive tract and
Zip code
Address 1981 Kamoda, Kawagoe-shi, SAITAMA 350-8550, JAPAN
TEL 048-228-3619
Email 05hishi@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satomi Oyama
Organization Saitama Medical Center,Saitama Medical University
Division name Department of digestive tract and
Zip code
Address 1981 Kamoda, Kawagoe-shi, SAITAMA 350-8550, JAPAN
TEL 048-228-3619
Homepage URL
Email 05hishi@saitama-med.ac.jp

Sponsor
Institute Saitama Medical Center,Saitama Medical University
Institute
Department

Funding Source
Organization Saitama Medical Center,Saitama Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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 ・埼玉医科大学総合医療センター(埼玉県)
・東松山医師会病院(埼玉県)
・福島県立医科大学病院(福島県)
・獨協医科大学病院(栃木県)
・東京女子医科大学東医療センター(東京都)
・高砂協立病院(東京都)
・帝京大学ちば総合医療センター(千葉県)
・松田病院(静岡県)
・金沢赤十字病院(石川県)
・順天堂大学医学部附属静岡病院(静岡県)
・千葉労災病院(千葉)
・高知大学医学部附属病院がん治療センター(高知)
・東邦大学医療センター佐倉病院(千葉)
・日本医科大学付属病院(東京都)
・友愛記念病院(茨城)
・獨協医科大学越谷病院(埼玉)
・上尾中央総合病院(埼玉)

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 12 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
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
2010 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 04 Month 12 Day
Last modified on
2017 Year 04 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005434

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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