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
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
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
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
