UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028101
Receipt number R000032172
Scientific Title Multicenter phase II study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel therapy for patients with resectable pancreatic cancer.
Date of disclosure of the study information 2017/08/15
Last modified on 2017/07/06 15:14:21

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Basic information

Public title

Multicenter phase II study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel therapy for patients with resectable pancreatic cancer.

Acronym

Multicenter phase II study of neoadjuvant GEM+nab-PTX for resectable pancreatic cancer.

Scientific Title

Multicenter phase II study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel therapy for patients with resectable pancreatic cancer.

Scientific Title:Acronym

Multicenter phase II study of neoadjuvant GEM+nab-PTX for resectable pancreatic cancer.

Region

Japan


Condition

Condition

Invasive ductal adenocarcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine Hematology and clinical oncology Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety and efficacy of gemcitabine+nab-paclitaxel therapy as neoadjuvant chemotharpy for resectable pancreatic cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

2 year progression-free survival rate (the initial date in reckoning is set at the date of registration)

Key secondary outcomes

Overall survival from registration
Radiological response rate
R0 resection rate
Histological response rate
Protocol compliance
Relative dose intensity
Incidence of adverse events


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

gemcitabine and nab-paclitaxel therapy as neoadjuvant therapy

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. Resectable pancreatic cancer
2. Adenocarcinoma or adenosquamous carcinoma
3. Age 20-79
4. ECOG PS 0-1
5. Able to eat orally
6. Appropriate biliary drainage if bile duct obstructed
7. No apparent sensory or motor neuropathy
8. No history of chemotherapy within last 3 years
9. No prior therapy for pancreatic cancer 10. Meet all the criteria of laboratory examination
11. Informed consent by patient

Key exclusion criteria

1. History of gemcitabine, nab-paclitaxel
2. Ongoing active other malignancy
3. Allergic to gemcitabine and nab-
4. Computed tomography contrast media allergy
5. poor control of diarrhea
6. Intestinal pneumonia
7. Moderate amount of ascites or pleural effusion
8. Active infection
9. Poor control of diabetes mellitus
10. Serious comorbid conditions
11.Myocardial infarction within last 6 months
12. Systemic steroid therapy
13. Serious psychiatric diseases
14. Planning a baby or pregnancy
15. Planning a baby
16. Judged unable to guarantee safety

Target sample size

45


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hirochika Toyama

Organization

Kobe University Graduate School of Medicine

Division name

Division of Hepato-biliary-pancreatic Surgery Department of Surgery

Zip code


Address

7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan

TEL

078-382-6302

Email

tymhr@me.com


Public contact

Name of contact person

1st name
Middle name
Last name Hirochika Toyama

Organization

Kobe University Graduate School of Medicine

Division name

Division of Hepato-biliary-pancreatic Surgery Department of Surgery

Zip code


Address

7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan

TEL

078-382-6302

Homepage URL


Email

tymhr@me.com


Sponsor or person

Institute

Division of Hepato-biliary-pancreatic Surgery Department of Surgery, Kobe University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Self-funding

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


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

神戸大学医学部附属病院


Other administrative information

Date of disclosure of the study information

2017 Year 08 Month 15 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

2017 Year 09 Month 01 Day

Date of IRB


Anticipated trial start date

2017 Year 09 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 07 Month 06 Day

Last modified on

2017 Year 07 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032172


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name