UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040275 |
|---|---|
| Receipt number | R000045945 |
| Scientific Title | The efficacy and safety of FOLFOXIRI for unresectable advanced rectal cancer : a prospective observational study |
| Date of disclosure of the study information | 2020/04/30 |
| Last modified on | 2023/01/03 06:37:06 |
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Basic information
Public title
The efficacy and safety of FOLFOXIRI for unresectable advanced rectal cancer : a prospective observational study
Acronym
The efficacy and safety of FOLFOXIRI for unresectable advanced rectal cancer : a prospective observational study
Scientific Title
The efficacy and safety of FOLFOXIRI for unresectable advanced rectal cancer : a prospective observational study
Scientific Title:Acronym
The efficacy and safety of FOLFOXIRI for unresectable advanced rectal cancer : a prospective observational study
Region
| Japan |
Condition
Condition
Rectal Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of FOLFOXIRI for patients with unresectable advanced rectal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Conversion Rate (R0 and R1 resection rate )
Key secondary outcomes
R0 resection rate
Response rate
Pathological response rate
Surgical morbidity and complications
The rate of early toxicity of neoadjuvant treatment
Relapse-free survival
Local relapse-free survival
Negative Circumferential Resection Margin
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Histologically confirmed colorectal adenocarcinoma
2.FOLFOXIRI as first-line
3.The lower margin of the tumor located between Rb and P
4.Clinical T4b or CRM positive by CT or MRI
5.M0 or M1 expected to be convertible with treatment
6.Age:20-80 years old
7.ECOG performance status 0-1
8.No prior chemotherapy or treatment such as rectal resection, pelvic lymph node dissection, or pelvic irradiation for any malignancies
9.Main organ function is maintained
10.Signed informed consent
Key exclusion criteria
1.Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval.
2.Active infections, including HBs antigen positive
3.Body temperature >= 38 degrees Celsius
4.Serious complications
5.Currently treated with systemic steroids or immunosuppressive agents
6.Not appropriate for the trial by other reasons
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Shiozawa |
Organization
Kanagawa Cancer Center
Division name
Department of Gastrointestinal Surgery
Zip code
241-8515
Address
2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
TEL
0455202222
shiozawam@kcch.jp
Public contact
Name of contact person
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Sugano |
Organization
Kanagawa Cancer Center
Division name
Department of Gastrointestinal Surgery
Zip code
241-8515
Address
2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
TEL
0455202222
Homepage URL
nsugano@kcch.jp
Sponsor or person
Institute
Kanagawa Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Cancer Center
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
Kanagawa Cancer Center
Address
2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa prefecture
Tel
0455202222
chiken-jimu4@kcch.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
横浜市立大学附属病院（神奈川）、横浜南共済病院（神奈川）、藤沢湘南台病院（神奈川）、済生会横浜市南部病院（神奈川）、平塚共済病院（神奈川）、神奈川県立足柄上病院（神奈川）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 30 | 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
| 2020 | Year | 04 | Month | 09 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 30 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To clarify the safety and efficacy of prior surgery with FOLFOXIRI followed by surgery for advanced lower rectal cancer for which it is difficult to secure CRM in TME.
Management information
Registered date
| 2020 | Year | 04 | Month | 30 | Day |
Last modified on
| 2023 | Year | 01 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045945
