UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031028 |
|---|---|
| Receipt number | R000035432 |
| Scientific Title | A phase II trial of FOLFOXIRI+Bevacizumab as preoperative chemotherapy for locally advanced lower rectal cancer |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2020/07/30 13:47:58 |
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Basic information
Public title
A phase II trial of FOLFOXIRI+Bevacizumab as preoperative chemotherapy for locally advanced lower rectal cancer
Acronym
A phase II trial of FOLFOXIRI+Bev as preoperative chemotherapy for lower rectal cancer
Scientific Title
A phase II trial of FOLFOXIRI+Bevacizumab as preoperative chemotherapy for locally advanced lower rectal cancer
Scientific Title:Acronym
A phase II trial of FOLFOXIRI+Bev as preoperative chemotherapy for lower rectal cancer
Region
| Japan |
Condition
Condition
Lower rectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
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
pathological complete response (pCR) rate
Key secondary outcomes
Feasibility, Response rate, Pathological response rate, Proportion of operative complication, Proportion of adverse events, R0 resection rate, Proportion of anus-preservation, 3 years progression free survival, 3 years overall survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Preoperative FOLFOXIRI+Bevacizumab followed by surgery
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. Pathologically proven adenocarcinoma.
2. Primary tumor located at Ra, Rb or P. The lower margin of the tumor located between Rb and P.
3. cT2N1-3M0 or cT3-4aN0-3M0 tumor
4. With or without lateral pelvic lymph node involvement.
5. Aged beteen 20 and 74 years old
6. Performance status of 0 or 1
7. Sufficient organ function as evidenced by the following laboratory studies within 14 days prior to enrollment
1) WBC count >=3,000 /mm3, <=12,000 /mm3
2) Neutrophil count >= 1,500 /mm3
3) Platelet count >= 100,000 /mm3
4) Hemoglobin >= 8.0 g/dL
5) AST, ALT <= 100 IU/L
6) T.Bil <= 1.5 mg/dL
6) Cr <= 1.5 mg/dL
8. Written informed consent
Key exclusion criteria
1. Previously treated with systemic chemotherapy, radiotherapy, hormone therapy, or immunotherapy for the present disease
2. Severe drug intorelance
3. Peripheral neuropathy (>= Grade 1)
4. Infectious disease to be treated
5. Uncontrollable hypertension
6. Uncontrollable diabetes mellitus
7. Severe heart disease such as congestive heart failure, pectoris, and myocardial infarction.
8. Severe pulmonary disease
9. Severe mental disease
10. Active bleeding from the intestine
11. Currently treated by Phenytoin, Warfarin, or Flucytosine.
12. Diarrhea(>= Grade 2)
13. Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ or mucosal carcinoma
14. Women during pregnancy, possible pregnancy or breast-feeding
15. Liver chirrhosis or hepatitis
16. UGT1A1*6/*6, UGT1A1*28/*28, or UGT1A1*6/*28
17. Attending physician determines that the case was inappropriate as the subject of this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takeru |
| Middle name | |
| Last name | Matsuda |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Surgery, Division of Gastrointestinal Surgery
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
078-382-5925
takerumatsuda@nifty.com
Public contact
Name of contact person
| 1st name | Takeru |
| Middle name | |
| Last name | Matsuda |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Surgery, Division of Gastrointestinal Surgery
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
078-382-5925
Homepage URL
takerumatsuda@nifty.com
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Graduate School of Medicine
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Japan
Tel
078-382-5925
tmatsuda@med.kobe-u.ac.jp
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
| 2018 | Year | 04 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 01 | Month | 18 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 27 | Day |
Last modified on
| 2020 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035432
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| Registered date | File name |
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