UMIN-CTR Clinical Trial

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
Email	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
Email	nsugano@kcch.jp

Sponsor
Institute	Kanagawa Cancer Center
Institute
Department

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
Email	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	Open public 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	2020 Year 04 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045945

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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