UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018624 |
|---|---|
| Receipt number | 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 11:21:44 |
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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
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
sur036@poh.osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021553
