UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053630 |
|---|---|
| Receipt number | R000061203 |
| Scientific Title | A Prospective Interventional Trial of Combination Therapy with hepatic arterial infusion of 5-FU and systemic infusion of Gemcitabine as Postoperative Adjuvant Therapy for Pancreatic Cancer |
| Date of disclosure of the study information | 2024/02/16 |
| Last modified on | 2024/02/15 23:17:06 |
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Basic information
Public title
A Prospective Interventional Trial of Combination Therapy with hepatic arterial infusion of 5-FU and systemic infusion of Gemcitabine as Postoperative Adjuvant Therapy for Pancreatic Cancer
Acronym
A Prospective Interventional Trial of Combination Therapy with hepatic arterial infusion of 5-FU and systemic infusion of Gemcitabine as Postoperative Adjuvant Therapy for Pancreatic Cancer
Scientific Title
A Prospective Interventional Trial of Combination Therapy with hepatic arterial infusion of 5-FU and systemic infusion of Gemcitabine as Postoperative Adjuvant Therapy for Pancreatic Cancer
Scientific Title:Acronym
A Prospective Interventional Trial of Combination Therapy with hepatic arterial infusion of 5-FU and systemic infusion of Gemcitabine as Postoperative Adjuvant Therapy for Pancreatic Cancer
Region
| Japan |
Condition
Condition
Patients with pancreatic cancer undergoing radical resection
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of present study is to confirm the efficacy of hepatic arterial infusion of 5-FU combined with systemic infusion of gemcitabine as adjuvant chemotherapy in patients with pancreatic cancer after resection of the primary tumor or hepatic metastases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of liver metastases occurring 5 years postoperatively
Key secondary outcomes
Overall survival, progression-free survival, safety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment | Maneuver |
Interventions/Control_1
After radical resection of pancreatic cancer, 5-FU hepatic arterial infusion and gemcitabine combination therapy are administered as adjuvant chemotherapy. The course of 28 days consists of 3 consecutive weeks of hepatic arterial infusion of 5-FU and intravenous administration gemcitabine on days 1, 8, and 15, with a break in week 4. 3 courses are repeated every 4 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) Patients who have been diagnosed as pancreatic cancer (pancreatic ductal carcinoma) by various imaging and pathological examinations and have undergone radical resection. Or, patients who have undergone hepatic resection for liver metastasis of pancreatic cancer and have undergone radical resection of the primary tumor.
2) No evidence of metastasis or recurrence by imaging diagnosis.
3) Patients must be at least 20 years of age.
4) Performance status (ECOG classification) of 0 or 1
5) No concurrent cancer of other organs
6) Preservation of major organ function (within 14 days prior to enrollment)
7) Have sufficient judgment to understand the study and provide written consent
Key exclusion criteria
1) Active multiple carcinoma (synchronous multiple carcinoma and heterochronic multiple carcinoma with a disease-free interval of 5 years or less) However, active multiple carcinoma does not include intraepithelial carcinoma or intramucosal carcinoma equivalent lesions that are considered curable with local treatment.
2) Have clear infection or inflammation requiring systemic treatment.
3) Fever of 38.0 degrees or higher at the time of enrollment
4) Allergy or contraindication to 5-FU or gemcitabine
5) History of serious drug hypersensitivity or drug allergy
6) Allergy to contrast media that precludes contrast studies
7) Serious cardiac disease or history of cardiac disease
8) Serious underlying disease (uncontrolled diabetes mellitus, renal failure, cirrhosis, etc.)
9) Has ascites or pleural effusion that is difficult to control
10) Active gastrointestinal bleeding requiring repeated blood transfusions
11) Diarrhea (more than 4 times a day or watery stools)
12) Uncontrolled cancer pain
13) Pulmonary fibrosis or interstitial pneumonia evident on imaging or clinical findings
14) Pregnant or lactating woman or possible (intended) pregnancy
15) Psychiatric illness or psychiatric symptoms that would preclude participation in the study
16) Unable to give consent to participate in this study
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Fujii |
Organization
Faculty of Medicine, Academic Assembly, University of Toyama
Division name
Department of Surgery and Science
Zip code
9300194
Address
2630, Sugitani, Toyama
TEL
076-434-7331
fjt@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Kazuto |
| Middle name | |
| Last name | Shibuya |
Organization
Faculty of Medicine, Academic Assembly, University of Toyama
Division name
Department of Surgery and Science
Zip code
9300194
Address
2630, Sugitani, Toyama
TEL
076-434-7331
Homepage URL
shibuyak@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
University of Toyama
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
Center for Clinical Research, Toyama University Hospital
Address
2630, Sugitani, Toyama
Tel
076-434-7331
rinri@adm.u-toyama.ac.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 16 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 16 | Day |
Last follow-up date
| 2032 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 15 | Day |
Last modified on
| 2024 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061203
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