UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019466 |
|---|---|
| Receipt number | R000022511 |
| Scientific Title | Phase II clinical trial on systemic oxaliplatin chemotherapy plus molecular target therapy combined with hepatic arterial infusion (HAI) therapy for colorectal liver metastases |
| Date of disclosure of the study information | 2015/10/23 |
| Last modified on | 2025/04/30 23:36:21 |
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Basic information
Public title
Phase II clinical trial on systemic oxaliplatin chemotherapy plus molecular target therapy combined with hepatic arterial infusion (HAI) therapy for colorectal liver metastases
Acronym
Systemic chemotherapy combined with HAI therapy for CRLM
Scientific Title
Phase II clinical trial on systemic oxaliplatin chemotherapy plus molecular target therapy combined with hepatic arterial infusion (HAI) therapy for colorectal liver metastases
Scientific Title:Acronym
Systemic chemotherapy combined with HAI therapy for CRLM
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of systemic chemotherapy plus molecular target therapy combined with hepatic arterial infusion (HAI) therapy for colorectal liver metastases.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Two-year relative-free survival after liver surgery
Overall survival
Key secondary outcomes
Adverse events
Response rate
Progression-free survival in unresectable cases
Intra- and extra-hepatic recurrence rate
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
| Medicine |
Interventions/Control_1
Period of intervension: 8 cycles of chemotherapy, mainly for 6 months.
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. Age >=20 yrs.
2. Pathologically proved colorectal cancer (CRC).
3. Liver-specific metastases.
4. Primary lesion resected or under controlled.
5. Metastatic target legions evaluable on imaging modalities, for example changes in sizes and numbers.
6. ECOG performance status 0 or 1.
7. Healthy primary organs satisfying all listed below:
- WBC >=2,000 /uL and <=2,000 /uL
- Neutrophil count >=1,500 /uL
- Platelet count >=85,000 /uL
- Hemoglobin >=8.0 g/dL
- AST (GOT) <=150 IU/L and ALT (GPT) <=175 IU/L
- Serum bilirubin >=2.0 mg/dL
- Serum creatinine >=1.8 mg/dL
- Normal electrocardiography
- Written informed consent from the objects
Key exclusion criteria
1. Intestinal pneumonia presenting clinical signs.
2. Severe infectious diseases.
3. Severely complicated diseases including heart failure, liver malfunction, renal failure and uncontrolled diabetes.
4. Anorexia
5. Women who are pregnant, lactate or have a probability of pregnancy.
6. History of allergy against fluorouracil, leucovorin, oxaliplatin and/or cetuximab.
7. Patients whom the researcher judged as ineligible.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Tanaka |
Organization
Tokai University School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
2591143
Address
143 Shimokasuya, Isehara, Kanagawa
TEL
0463-93-1121
akira-tanaka@eva.hi-ho.ne.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Tanaka |
Organization
Tokai University School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
2591143
Address
143 Shimokasuya, Isehara, Kanagawa
TEL
0463-93-1121
Homepage URL
http://irb.med.u-tokai.ac.jp/d/2/research-list.html
akira-tanaka@eva.hi-ho.ne.jp
Sponsor or person
Institute
Department of Gastroenterological Surgery, Tokai University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Tokai University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokai University School of Medicine
Address
143 Shimokasuya, Isehara, Kanagawa, Japan
Tel
0463931121
akira-tanaka@eva.hi-ho.ne.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
東海大学医学部付属病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 23 | Day |
Related information
URL releasing protocol
http://irb.med.u-tokai.ac.jp/d/2/research-list.html
Publication of results
Unpublished
Result
URL related to results and publications
-
Number of participants that the trial has enrolled
47
Results
The median OS was 59M (95% CI: 40-65) and the median PFS was 20M (14-20) in all the cases included. Among the liver resected cases, the median OS was 100M (50-NA) and the median DFS was 26M (14-NA) indicating the poor improvement of survival with this study strategy compared to surgery alone.
Results date posted
| 2025 | Year | 04 | Month | 30 | Day |
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
| 2015 | Year | 10 | Month | 22 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 23 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 22 | Day |
Last modified on
| 2025 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022511
