UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000006583
Receipt No. R000007797
Scientific Title Multicancer Phase II study of mFOLFOX6 as Neoadjuvant chemotherapy for T3 or T4 Stage II / III rectal cancer
Date of disclosure of the study information 2011/10/21
Last modified on 2014/10/21

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Multicancer Phase II study of mFOLFOX6 as Neoadjuvant chemotherapy for T3 or T4 Stage II / III rectal cancer
Acronym Phase II study of mFOLFOX6 as Neoadjuvant chemotherapy for rectal cancer (FACT)
Scientific Title Multicancer Phase II study of mFOLFOX6 as Neoadjuvant chemotherapy for T3 or T4 Stage II / III rectal cancer
Scientific Title:Acronym Phase II study of mFOLFOX6 as Neoadjuvant chemotherapy for rectal cancer (FACT)
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy and safety of mFOLFOX6 as Neoadjuvant chemotherapy for T3 or T4 Stage II / III rectal cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Preoperative respose rate
Key secondary outcomes Pathological evaluation, R0 resection rate, Pathological complete respose rate, Down stage rate, Adverse events, The percentage of patients who complete scheduled treatment, Incidence of surgical morbidity and mortality

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
Interventions/Control_1 Fluororacil / l-leucovorin plus oxaliplatin (mFOLFOX6)
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1. Stage II / III rectal caner
2. Depth invasion: T3 or T4
3. No prior surgery for rectum
4. No prior chemotherapy for rectal cancer
5. No prior radiotherapy
6. Age: 20-80
7. Performance status(ECOG): 0-1
8. Adequate bone marrow, liver and renal functions
9. Patients who can perform an surgery for rectum 2-6 weeks after chemotherapy.
10. Written informed concent.
Key exclusion criteria 1. Comorbidity of active double cancer
2. Peripheral sensory nerve disorder
3. Poor controled hypertension
4. Poor controled diabetes mellitus
5. Severe electrocardiographic abnormality or comorbidity of poor controled heart failure
6. Comorbidity of severe pulmonary diease
(interstitial lung disease, pulmonary
fibrosis, emphysema pulmonum and so on)
7. Poor controlled psychiatric disorder
or history of central nervous system disorder
8. Watery diarrhea
9. Treated continuously with systemic steroids
10. Pregnant or lactating women or women childbearing potential
11. Any other cases who are regarded as inadequate for study enrollment by the investigator.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shingo Kameoka
Organization Tokyo Women's Medical University Hospital
Division name Surgery 2
Zip code
Address 8-1, KAWATACHO, SHINJYUKU-KU, TOKYO
TEL 03-3353-8111
Email itabashi@surg2.twmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Michio Itabashi MD
Organization FACT Investigator Group
Division name Tokyo Women's Medical University Hospital
Zip code
Address 8-1, KAWATACHO, SHINJYUKU-KU, TOKYO
TEL 03-3353-8111
Homepage URL
Email itabashi@surg2.twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical University Hospital
Institute
Department

Funding Source
Organization Tokyo Women's Medical University Hospital
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 FACT Investigator Group

Other administrative information
Date of disclosure of the study information
2011 Year 10 Month 21 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 No longer recruiting
Date of protocol fixation
2011 Year 07 Month 12 Day
Date of IRB
Anticipated trial start date
2011 Year 08 Month 01 Day
Last follow-up date
2016 Year 01 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
2011 Year 10 Month 21 Day
Last modified on
2014 Year 10 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007797

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.