UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057114 |
|---|---|
| Receipt number | R000065271 |
| Scientific Title | A prospective observational study on the efficacy and safety of neoadjuvant gemcitabine + nab-paclitaxel chemotherapy on survival for curative unresectable pancreatic body and tail cancer with imaging-based splenic artery and vein invasion |
| Date of disclosure of the study information | 2025/02/21 |
| Last modified on | 2025/02/21 20:13:10 |
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Basic information
Public title
A prospective observational study on the efficacy and safety of neoadjuvant gemcitabine + nab-paclitaxel chemotherapy on survival for curative unresectable pancreatic body and tail cancer with imaging-based splenic artery and vein invasion
Acronym
A prospective observational study on the efficacy and safety of neoadjuvant gemcitabine + nab-paclitaxel chemotherapy on survival for curative unresectable pancreatic body and tail cancer with imaging-based splenic artery and vein invasion
Scientific Title
A prospective observational study on the efficacy and safety of neoadjuvant gemcitabine + nab-paclitaxel chemotherapy on survival for curative unresectable pancreatic body and tail cancer with imaging-based splenic artery and vein invasion
Scientific Title:Acronym
A prospective observational study on the efficacy and safety of neoadjuvant gemcitabine + nab-paclitaxel chemotherapy on survival for curative unresectable pancreatic body and tail cancer with imaging-based splenic artery and vein invasion
Region
| Japan |
Condition
Condition
Pancreatic body/tail cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Statistical evaluation of the efficacy and safety of neoadjuvant gemcitabine + nab-paclitaxel chemotherapy on survival time for unresectable pancreatic body and tail cancer with imaging-based splenic artery and vein invasion
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival time after protocol therapy.
Key secondary outcomes
1. Recurrence free survival time after protocol therapy.
2. Safety of protocol therapy (CTCAE Ver 4.0.)
3. Incicence of morbidity (equal to more than grade I of Clavien Dindo classification).
4. Response rate, disease control rate.
5. Preoperative/postoperative tumor marker (CA19-9, CEA), rate of normalization.
6. Reduction rate of SUVmax value on PET-CT(limited to available patients)
7. Chemotherapeutic effect (grade based on Evans classification).
8. Resection rate.
9. R0 resection rate.
10. Surgical data(operative time, blood loss, transfusion, postoperative hospital day), overall morbidity rates (reoperation, rate of re-admission, mortality).
11. Incoidence of all morbidity.
12. Rate of patient undergo postoperative adjuvant therapy (entry rate, completion rate).
13. Dose intensity
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Histologically or cytologically diagnosed with pancreatic body/tail adenocarcinoma, radiologically involving splenic artery and/or vein, and consistent with NCCN guideline (Version 1.2020) resectable-arterial, resectable-venous.
2. Measurable lesion.
3. First-line treatment.
4. PS(ECOG) 0-1.
5. Equal to or more than 18 years old
6. The following criteria must be satisfied in laboratory tests within 14 days of registration: WBC count equal to or less than 12,000/mm3, Neutrophil count equal to or more than 1,500/mm3, Hb equal to or more than9.0g/dl, Plt equal to or more than 100,000/mm3, T.Bil less than2.0mg/dl(equal to or less than 3.0mg/dl in biliary drainage case), Serum Cr equal to or less than1.5 mg/dl, AST,ALT equal to or less than 2.5xULN.
7. Written informed consent to participate in this study was also required.
Key exclusion criteria
i) Severe drug hypersensitivity.
ii) Multiple primary cancers within five years.
iii) Severe infection.
iv) Severe peripheral neuropathy of Grade 2 or more.
v) Interstitial pneumonia or pulmonary fibrosis.
vi) Uncontrollable pleural effusion or ascites.
vii) Uncontrollable diabetes mellitus.
viii) Uncontrollable heart failure, angina, hypertension and arrhythmia.
ix) Severe neurological/psychological symptoms.
x) Watery diarrhea.
xi) Pregnant or lactating women or women with unknown or suspected pregnancy.
xii) Inappropriate patients for enrollment based on the judgement of the researchers.
xiii) Diagnosed as resectable/unresectable pancreatic carcinoma according to NCCN guideline (Version 1.2020).
xiv) Active hepatitis B.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ken-ichi |
| Middle name | |
| Last name | Okada |
Organization
Tokai University School of Medicine
Division name
Department of Gastroenterological Surgery,
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa, JAPAN
TEL
0463931121
kokada@tokai.ac.jp
Public contact
Name of contact person
| 1st name | Ken-ichi |
| Middle name | |
| Last name | Okada |
Organization
Tokai University Scool of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa, JAPAN
TEL
0463931121
Homepage URL
kokada@tokai.ac.jp
Sponsor or person
Institute
Department of Gastroenterological Surgery, Tokai University Scool of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Tokai University
Address
143 Shimokasuya, Isehara, Kanagawa, JAPAN
Tel
0463931121
kokada@tokai.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
| 2025 | Year | 02 | Month | 21 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 02 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 19 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A prospective cohort study of unresectable pancreatic body and tail cancer with imaged splenic artery and vein invasion (maximum follow-up period of 5 years).The primary endpoint, overall survival time analysis, will be compared with the survival curve of literature data using the Kaplan-Meier method, and significant differences will be tested using the log-rank test.
Management information
Registered date
| 2025 | Year | 02 | Month | 21 | Day |
Last modified on
| 2025 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065271
