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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name