UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031822 |
|---|---|
| Receipt number | R000036343 |
| Scientific Title | Neoadjuvant nab-paclitaxel plus gemcitabine therapy for resectable pancreatic cancer; A phase II multicenter trial |
| Date of disclosure of the study information | 2018/03/20 |
| Last modified on | 2022/09/27 09:35:37 |
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Basic information
Public title
Neoadjuvant nab-paclitaxel plus gemcitabine therapy for resectable pancreatic cancer; A phase II multicenter trial
Acronym
HOPS-R02
Scientific Title
Neoadjuvant nab-paclitaxel plus gemcitabine therapy for resectable pancreatic cancer; A phase II multicenter trial
Scientific Title:Acronym
HOPS-R02
Region
| Japan |
Condition
Condition
Resectable pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology | Hepato-biliary-pancreatic surgery |
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To estimate the safety and the efficacy of neoadjuvant nab-paclitaxel plus gemcitabine therapy for resectable pancreatic cancer patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Two year disease free survival
Key secondary outcomes
Overall survival, Progression free survival, R0 resection rate, Response rate of diagnostic imaging, Pathological chemotherapy effect, Adverse events, Rate of preoperative treatment completion, Rate of protocol achievement, Surgical complication
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 | Maneuver |
Interventions/Control_1
1) Preoperative therapy: 2 course of gemcitabine and nab-PTX combination therapy (28days for one course:day1, day8, day15 nab-PTX:125mg/m2/day+GEM:1000mg/m2/day) or total six time administration
2) Surgical resection
3) Postoperative therapy: 4 course of S-1 monotherapy (42days for one course:day1-28 S-1 80mg/m2)
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Resectable pancreatic cancer (JPS7th)
2.Pathological or cytologically proven invasive ductal adenocarcinoma or adenosquamous carcinoma
3.No distant metastasis
4.Age over 20 or under 80
5.ECOG performance status 0-1
6.No history of chemo therapy within 3 years.
7.No history of pancreatic cancer therapy
8.No problems for oral intake
9.Neither peripheral sensory neuropathy nor peripheral motor neuropathy
10.In the case of obstructive jaundice, appropriate bileduct drainage is performed
11.No findings of gastrointestinal infiltration protruding into the lumen and or gastrointestinal bleeding
12.The latest inspection value within 14 days before registration satisfies all of the following. 1) White blood cell count more than 3,000 / mm 3, 2) Hemoglobin more than 9.0 g / dL (no transfuse within 7 days before registration), 3) Platelet count more than 10 x 10 4 / mm 3, 4) Albumin more than 3.0 g / dL, 5) Total bilirubin less than 2.0 mg / dL (3.0 mg / dL or less in case of bileduct drainarge), 6) AST less than 100 U / L (150 IU / L or less in case of bileduct drainarge), 7) ALT less than 100 U / L (150 IU / L or less in case of bileduct drainarge), 8) Serum creatinine less than 1.2 mg / dL, 9) Creatinine clearance 50 ml / min or more
13.Written informed consent
Key exclusion criteria
1.GEM, nab-PTX or fluorinated pyrimidine anticancer drugs have been treated.
2.Severe diarrhea with uncontrolled bowel movement
3.Phenytoin, warfarin potassium, flucytosine are used.
4.History of sever allergic reaction with nab-paclitaxel, paclitaxel or albumin
5.Drug allergy to iodine contrast medium and impossible to perform contrast CT imaging. However, do not exclude the case of contrast-enhanced CT imaging with steroid prophylaxis.
6.Pulmonary fibrosis or interstitial pneumonia
7.Patients with medium or more pleural effusion or ascites
8.Active infection (Clinically stable HBV and chronic viral hepatitis by HCV are excluded).
9.Uncontrolled diabetes
10.Active double cancer (Synchronous double cancer and metachronous double cancer with disease-free period within 3 years). However, lesions such as carcinoma in situ that are cured by topical therapy are not included in active double cancers.
11.Active digestive ulcer
12.Serious complications (heart failure, renal failure, liver failure, intestinal palsy, etc).
13.Myocardial infarction within six months
14.Continuous systemic administration of steroids
15.Sever mental disorder
16.Women who are pregnant / lactating or pregnant or willing, or wish to baby.
17.A man who wishes to become a partner's pregnant.
18.Inappropriate physical condition as diagnosed by the attending physician
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Hirano |
Organization
Hokkaido University
Division name
Gastroenterological Surgery II
Zip code
060-8638
Address
N15, W7, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-7714
satto@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Nakamura |
Organization
Hokkaido University
Division name
Gastroenterological Surgery II
Zip code
060-8638
Address
N15, W7, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-7714
Homepage URL
torunakamura@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido Pancreatic Cancer Study Group (HOPS)
Institute
Department
Personal name
Funding Source
Organization
None
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
Hokkaido University Certified Review Board
Address
N15, W7, Kita-ku, Sapporo, Hokkaido, Japan
Tel
011-706-7934
recjimu@huhp.hokudai.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
| 2018 | Year | 03 | Month | 20 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2024 | 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
| 2018 | Year | 03 | Month | 20 | Day |
Last modified on
| 2022 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036343
