UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055760 |
|---|---|
| Receipt number | R000063729 |
| 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 | 2024/11/08 |
| Last modified on | 2024/10/07 12:54:59 |
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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 and tail adenocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Efficacy and safety of preoperative chemotherapy with gemcitabine and nab-paclitaxel for survival in patients with unresectable pancreatic body and tail cancer with splenic arterial and vein invasion.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival after initiation of protocol treatment
Key secondary outcomes
1. Recurrence-free survival after initiation of protocol treatment
2. Safety (adverse events) of protocol treatment (gemcitabine + nab-paclitaxel therapy) (CTCAE Ver 4.0.)
3. Rate of all surgical complications of Clavien-Dindo classification Grade III or higher during postoperative hospital stay
4. Response rate of preoperative chemotherapy (RECIST Ver1.1) and disease control rate
5. Tumor marker (CA19-9, CEA) normalization rate before and after preoperative chemotherapy
6. Reduction rate of SUVmax value of primary tumor by PET-CT examination
7. Histological treatment effect (Grade based on tumor cell disappearance rate according to Evans criteria)
8. Resection rate
9. Radical resection rate (R1 or R0; R1: no macroscopic residual cancer, R0: no histological residual cancer)
10. Surgery-related results (operation time, blood loss, transfusion, length of hospital stay after surgery)
11. Postoperative complication rate (reoperation rate, readmission rate within 90 days after discharge, surgery-related mortality)
12. Adjuvant chemotherapy initiation 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 Cases in which the primary lesion has been confirmed to be pancreatic cancer by histology, cytology, or imaging, and the extent of the disease has been diagnosed by imaging diagnosis, and among cases that meet the criteria for resectable pancreatic body and tail cancer in the NCCN Guidelines (Version 1.2020), those with unresectable pancreatic body and tail cancer with splenic artery and vein invasion by imaging diagnosis
2 Cases with measurable lesions
3 Cases undergoing initial treatment
4 Cases with performance status (ECOG)of 0 or 1
5 Cases aged 18 years or older at the time of consent
6 Cases whose major organ functions meet the following criteria(latest values within 14 days prior to enrollment)
White blood cells: up to12,000/mm3
Neutrophils: over 1,500/mm3
Hemoglobin level: over 9.0g/dL
Platelets: over 100,000 /mm3
Total bilirubin:less than 2.0mg/dL (less than 3.0mg/dL in cases of reduced jaundice)
Serum creatinine: up to 1.5mg/dL
AST and ALT: 2.5 X upper limit of facility standard or less
7 Patients who have signed consent to participate in this study prior to enrollment
Key exclusion criteria
1. Patients with a history of severe drug hypersensitivity or drug allergy
2. Patients with a history of malignant tumors (Patients with a recurrence-free period of 5 years or more, and patients with endoscopically curatively resected intramucosal cancer, curatively resected cervical cancer, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin may be enrolled)
3. Patients with active infections
4. Patients with peripheral sensory neuropathy (Grade 2 or higher)
5. Patients with a history of interstitial pneumonia or pulmonary fibrosis
6. Patients with uncontrollable ascites or pleural effusion
7. Patients with uncontrollable diabetes mellitus
8. Patients with uncontrollable congestive heart failure, angina pectoris, hypertension, or arrhythmia
9. Patients with a history or comorbidity of significant neurological or psychiatric disease
10. Patients with diarrhea (including increased stool frequency and watery stools)
11. Pregnant women, lactating women, and those who may be pregnant (or intend to become pregnant), or those who have been pregnant for a certain period (180 days) during the clinical trial or after the final administration of the investigational drug Women and men who have no intention of using contraception.
12. Other cases that a doctor judges to be inappropriate for participation in the clinical trial.
13. Those whose stage of disease is diagnosed by MDCT and meets the Borderline Resectable/Unresectable criteria of the NCCN Guidelines (Version 1.2020).
14. Patients with active hepatitis B
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Okada |
Organization
Tokai University School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
2591193
Address
Shimokasuya 143, Isehara city, Kanagawa
TEL
0463931121
kokada@tokai.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihito |
| Middle name | |
| Last name | Masuoka |
Organization
Tokai University School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
2591193
Address
Shimokasuya 143, Isehara city, Kanagawa
TEL
0463931121
Homepage URL
y-masu@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University School of Medicine
Institute
Department
Personal name
Kenichi Okada
Funding Source
Organization
Tokai University School of Medicine
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
Tokai University School of Medicine
Address
Shimokasuya 143, Isehara city, Kanagawa
Tel
0463931121
tokai-rec@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
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
| 2024 | Year | 11 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 10 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
not applicable
Management information
Registered date
| 2024 | Year | 10 | Month | 07 | Day |
Last modified on
| 2024 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063729
