UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	TANDEM-IRI-TACE combined with systemic FOLFIRI for colorectal liver metastases after oxaliplatin regimen failure: Phase I dose escalation study
Title of the study (Brief title)	TANDEM-IRI-TACE
Region	Japan

Condition
Condition	Colorectal Cancer
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this Phase I study is to estimate the recommend dose (RD) of loaded irinotecan in TANDEM-IRI-TACE combined with systemic FOLFIRI.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	Dose Limiting Toxicity,Recommended Dose
Key secondary outcomes	pharmacokinetics of irinotecan, tumor response, progression free survival, overall survival

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	TACE will be conducted every 5 weeks. Systemic FOLFIRI will be conducted every 2 weeks.
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 carcinoma with unresectable liver metastases. 2. Metastatic hepatic lesion as the most prior prognostic factor. 3. Refractory with standard oxaliplatin based-chemotherapy. No history of chemotherapy 2 weeks before. 4. Existing measurable hepatic lesion Response Evaluation Criteria in Solid Tumor (RECIST) or modified RECIST is applicable (More than two times thickness slice). 5. Performance Status (ECOG): 0,1,2 6. Adequate organ functions: bone marrow, Heart, renal function (2 weeks before entry) WBC (or Neut): >= 3000/mm3 (or >=1500/mm3) Plt: >=7.5x104/mm3 T-Bil: <=2.5mg/dl Serum Cre: <=1.2mg/dl AST: < 5 times ULN ALT: < 5 times ULN 7. Age: more than 20 y.o 8. Expected survival time over 8 weeks 9. Written informed consent
Key exclusion criteria	1 Previous pancreato-biliary surgery or post endoscopic sphincteropapillotomy 2. Serious complications 3. Concomitant malignancy 4. A history of allergy to iodine containing agents or contrast media, irinotecan and 5FU 5. Presence of remarkable AP shunts or AV shunts 6. UGT1A1 6, UGT1A1 28
Target sample size	9

Research contact person
Name of lead principal investigator	Kimihiko Kichikawa
Organization	Nara Medical University Hospital
Division name	Radiology and IVR Center
Address	840 Sijo-cho,kashihara-city,Nara,Japan
TEL	+81-744-22-3051
Email	rad@naramed-u.ac.jp

Public contact
Name of contact person	Toshihiro Tanaka
Organization	Nara Medical University Hospital
Division name	Radiology and IVR Center
Address	840 Sijo-cho,kashihara-city,Nara,Japan
TEL	+81-744-22-3051
Homepage URL
Email	toshihir@bf6.so-net.ne.jp

Sponsor
Institute	Radiology, Nara Medical University
Institute
Department

Funding Source
Organization	Radiology, Nara Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2014 Year 10 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 09 Month 01 Day
Anticipated trial start date	2014 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2017 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 10 Month 08 Day
Last modified on	2017 Year 10 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017884