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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018624
Receipt No. R000021553
Scientific Title A phase II randomized controlled trial comparing perioperative mFOLFOXIRI with perioperative chemoradiotherapy for locally advanced rectal cancer.
Date of disclosure of the study information 2015/08/10
Last modified on 2018/02/15

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Basic information
Public title A phase II randomized controlled trial comparing perioperative mFOLFOXIRI with perioperative chemoradiotherapy for locally advanced rectal cancer.
Acronym A phase II randomized controlled trial comparing perioperative mFOLFOXIRI with perioperative chemoradiotherapy for locally advanced rectal cancer.
Scientific Title A phase II randomized controlled trial comparing perioperative mFOLFOXIRI with perioperative chemoradiotherapy for locally advanced rectal cancer.
Scientific Title:Acronym A phase II randomized controlled trial comparing perioperative mFOLFOXIRI with perioperative chemoradiotherapy for locally advanced rectal cancer.
Region
Japan

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

Objectives
Narrative objectives1 Safety, Efficacy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes RFS:3 years relapse free survival
Key secondary outcomes Response rate, Proportion of patients with R0 resection, Pathological response, 3 years progression free survival, 3 years overall survival, Incidence of adverse events, Proportion of operative complication, Proportion of anus-preservation without stoma, Evaluation of anal function, Evaluation of bladder function

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 preoperative FOLFOXIRI+surgery
Interventions/Control_2 preoperative chemoradiotherapy+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
74 years-old >=
Gender Male and Female
Key inclusion criteria 1. Pathologically proven adenocarcinoma.
2. Primary tumor located at Rectosigmoid, Upper rectum, Lower rectum, and Anal canal.The lower border of the tumor located between the peritoneal reflection and the anal verge.
3. cT3and cT4a tumor on contrast-enhanced CT or MRI
4. Lateral lymph nodes without 7mm and more in short axis diameter on contrast-enhanced CT or MRI data of 5mm-thickness slices (cN0-cN2) .
5. No distant metastasis on contrast-enhanced CT or MRI (cM0)
6. Aged 20 to 74 years old
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
8. Adequate organ function as evidenced by the following laboratory studies within 14 days prior to enrollment
1) Neutrophil count >= 1,500 /mm3
2) Platelet count >= 100,000 /mm3
3) Hemoglobin >= 9.0 g/dL
4) T.Bil =< 2.0 mg/dL
5) AST =< 100 IU/L, ALT =< 100 IU/L
6) Cr =< 1.5 mg/dL
9. Written informed consent
Key exclusion criteria 1. Currently treated with systemic steroids or immunosuppressive agent
2. Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ or mucosal carcinoma
3. Infectious disease to be treated
4. Positive for HBs antigen
5. Uncontrollable hypertension, Uncontrollable diabetes mellitus, Uncontrollable arrhythmia, and severe clinical problem
6. Grade 1 or more peripheral neuropathy
7. Women during pregnancy, possible pregnancy or breast-feeding
8. Severe mental disease
9. Attending physician determines that the case was inappropriate as the subject of this study
Target sample size 34

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhisa Uchiyama
Organization Osaka Medical College Hospital
Division name Department of general and gastroenterological surgery
Zip code
Address 2-7 Daigaku-machi, Takatsuki City, Osaka, Japan
TEL 072-683-1221
Email uchi@poh.osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keitarou Tanaka
Organization Osaka Medical College Hospital
Division name Department of general and gastroenterological surgery
Zip code
Address 2-7 Daigaku-machi, Takatsuki City, Osaka, Japan
TEL 072-683-1221
Homepage URL
Email sur036@poh.osaka-med.ac.jp

Sponsor
Institute Osaka Medical College Hospital
Institute
Department

Funding Source
Organization Osaka Medical College 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 大阪医科大学附属病院

Other administrative information
Date of disclosure of the study information
2015 Year 08 Month 10 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
2015 Year 07 Month 06 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 20 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
2015 Year 08 Month 10 Day
Last modified on
2018 Year 02 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021553

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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