UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015367
Receipt number R000017884
Scientific Title TANDEM-IRI-TACE combined with systemic FOLFIRI for colorectal liver metastases after oxaliplatin regimen failure: Phase I dose escalation study
Date of disclosure of the study information 2014/10/08
Last modified on 2017/10/10 13:40:44

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Basic information

Public title

TANDEM-IRI-TACE combined with systemic FOLFIRI for colorectal liver metastases after oxaliplatin regimen failure: Phase I dose escalation study

Acronym

TANDEM-IRI-TACE

Scientific Title

TANDEM-IRI-TACE combined with systemic FOLFIRI for colorectal liver metastases after oxaliplatin regimen failure: Phase I dose escalation study

Scientific Title:Acronym

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

1st name
Middle name
Last name Kimihiko Kichikawa

Organization

Nara Medical University Hospital

Division name

Radiology and IVR Center

Zip code


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

1st name
Middle name
Last name Toshihiro Tanaka

Organization

Nara Medical University Hospital

Division name

Radiology and IVR Center

Zip code


Address

840 Sijo-cho,kashihara-city,Nara,Japan

TEL

+81-744-22-3051

Homepage URL


Email

toshihir@bf6.so-net.ne.jp


Sponsor or person

Institute

Radiology, Nara Medical University

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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

2014 Year 09 Month 01 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017884


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name