UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030717 |
|---|---|
| Receipt number | R000035070 |
| Scientific Title | The phase 2 study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel+S-1 for patients with biological borderline resectable pancreatic cancer. |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2019/10/04 17:00:36 |
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Basic information
Public title
The phase 2 study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel+S-1 for patients with biological borderline resectable pancreatic cancer.
Acronym
The phase 2 study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel+S-1 for patients with biological borderline resectable pancreatic cancer.
Scientific Title
The phase 2 study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel+S-1 for patients with biological borderline resectable pancreatic cancer.
Scientific Title:Acronym
The phase 2 study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel+S-1 for patients with biological borderline resectable pancreatic cancer.
Region
| Japan |
Condition
Condition
Pancreatic ductal adenocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of a biweekly combination neoadjuvant chemotherapy including gemcitabine, nab-paclitaxel, and S-1 (GAS) for patients with Biological borderline resectable pancreatic cancer which have no contact or less than 180 degre of portal vein contact and more tha 500 U/ml of preoperatine Ca19-9 level.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Over all survival after initiation of protocol therapy and median survival time
Key secondary outcomes
-Disease free survival after initiation of protocol therapy
-Adverse events
-postoperative complication with more than grade 3
-Response rate and normalization rate of tumormarkers after neoadjuvant chemotherapy
-Histological responce (Evans grade)
-Curative resection rate
-Short time outcomes after surgical resection
-Reoperation rate, readmission rate and mortality
-Initiation and completion rate of adjuvant chemotherapy
-Dose intensity
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients were assigned to the following levels of GAS regimens. Nab-paclitaxel was administered intravenously at 125 mg/m2, followed by intravenous gemcitabine at 1000 mg/m2. A daily dose of S1 was defined based on the patient's body surface area as follows:<1.25m2,60mg;1.25-1.5m2,80mg;>1.5m2,100mg. S1 administered orally twice a day on days 1-7. The treatment cycle was repeated every 2 weeks. After 6 cycles of the GAS chemotherapy regimen, patients were reevaluated to assess resectability and response to the treatment.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) a histologically or cytologically proven diagnosis of adenocarcinoma or adenosquamous carcinoma
(2) no distant metastasis
(3) tumor with no contact with the major arteries including the superior mesenteric artery, celiac artery, or common hepatic artery on pretreatment computed tomography (CT)
(4)tumor with no contact or less than 180 dgree contact with portal vein
(5)More than 500 U/ml of pretreatment serum CA19-9 level
(6)Initial treatment
(7)0 or 1 of Performance status(ECOG)
(8)Age between 20 and 79
(9)dequate hematological, hepatic, and renal functions by hemoglobin >8.0 g/dL, leucocytes >3,000 /mm3 and <12,000 /mm3, neutrophils >1,500 /mm3, platelets >100,000 /mm3, total bilirubin <2.0mg/dL, aspartate aminotransferase and alanine aminotransferase<Normal upper limit x2.5, serum creatinine <1.5mg/dL,
Key exclusion criteria
1.Severe allergy for protcol drugs
2.Histly of active malignant disease within 5 years
3. Active infectious disease
4. >Geade2 of neuropahty
5. Ileus
6. Active interstitional pneumonia
7. Uncontrolable ascites and pleural effusion
8.Uncontrolable diabetes
9.Uncontrolable heart diseases
10.Histry of sevese neurological sidease
11.Pregnancy or possibility of pregnancy
12.Others who were judged to be not appropriate for participation to this clinicalrial by attending physician
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiaki Murakami |
Organization
Hiroshima University Hospital
Division name
Gastrointestinal Surgery
Zip code
Address
1-2-3, Kasumi, Minami-Ku, Hiroshima, JAPAN, 7340037
TEL
082-257-5216
mura777@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naru Kondo |
Organization
Hiroshima University Hospital
Division name
Gastrointestinal Surgery
Zip code
Address
1-2-3, Kasumi, Minami-Ku, Hiroshima, JAPAN, 7340037
TEL
082-257-5216
Homepage URL
k-naru-surg@hiroshima-u.ac.jp
Sponsor or person
Institute
Department of gastrointestinal Surgery, Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of gastrointestinal Surgery, Hiroshima University Hospital
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 04 | Month | 01 | 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
| 2018 | Year | 01 | Month | 09 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 04 | Day |
Last follow-up date
| 2022 | 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 | 01 | Month | 07 | Day |
Last modified on
| 2019 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035070
