UMIN-CTR Clinical Trial

Public title

Phase II study of Neoadjuvant chemotherapy with Gemcitabine and S1 (GS therapy) for resectable pancreatic carcinoma

Acronym

Phase II study of Neoadjuvant chemotherapy with Gemcitabine and S1 (GS therapy) for resectable pancreatic carcinoma

Scientific Title

Phase II study of Neoadjuvant chemotherapy with Gemcitabine and S1 (GS therapy) for resectable pancreatic carcinoma

Scientific Title:Acronym

Phase II study of Neoadjuvant chemotherapy with Gemcitabine and S1 (GS therapy) for resectable pancreatic carcinoma

Region

Japan

Condition

resectable pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Efficacy and feasibilty for gemcitabine and S1 therapy as Neoadjuvant against pancreatic cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

2 year survival rate

Key secondary outcomes

Adverse effect, resectability rate, pathological effect, recurrence free survival, patterns of recurrence, reduction rate and normalization rate for tumor marker

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Neoadjuvant treatment with gemcitabine and S1

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

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) invasive ductal carcinoma of the pancreas
2) no distant metastasis
3) R0/1 resectable
4) all adult who anticipate to undergo pancreatectomy
5) no prior therapy
6) written informed consent

Key exclusion criteria

1) pulmonary fibrosis or interstitial pneumonitis
2) tumor other than ductal carcinoma
3) distant metastasis
4) R2 resection
5) prior anti-cnacer therapy
6) pregnancy
7) under 18 years old

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Michiaki Unno

Organization

Tohoku University Hospital

Division name

Hepato-Biliary Pancreatic surgery

Zip code

Address

1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan

TEL

022-717-7205

Email

Name of contact person

1st name
Middle name
Last name	Motoi Fuyuhiko

Organization

Tohoku University Hospital

Division name

Hepato-Biliary Pancreatic surgery

Zip code

Address

1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan

TEL

022-717-7205

Homepage URL

Email

fmotoi@surg1.med.tohoku.ac.jp

Institute

Department of surgery, Tohoku University

Institute

Department

Personal name

Organization

None (Self-funding)

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

Miyagi HBP COG

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2008

Year

11

Month

13

Day

URL releasing protocol

http://www.surg1.med.tohoku.ac.jp/class/hbpcog.html

Publication of results

Published

URL related to results and publications

http://www.annsurgoncol.org/index.html

Number of participants that the trial has enrolled

Results

Of 36 patients enrolled, 35 were eligible for this
clinical trial conducted between 2008 and 2010. The most common toxicity was neutropenia in response to 90 % of the relative dose intensity. Responses to NAC included radiological tumor shrinkage (69 %) and decreases in CA19-9 levels (89 %). R0 resection was performed for 87 % in resection, and the morbidity rate (40 %) was acceptable. The 2-year survival rate of the total cohort was 45.7 %. Patients who underwent resection without metastases after NAC-GS (n = 27) had an increased median overall survival (34.7 months) compared with those who did not undergo resection (P = 0.0017). NAC-GS was well tolerated and safe when used in a multi-institutional setting. The R0 resection rate and the 2-year survival rate analysis are encouraging for patients with resectable and borderline PDAC.

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

Recruitment status

Completed

Date of protocol fixation

2008

Year

10

Month

27

Day

Date of IRB

Anticipated trial start date

2008

Year

11

Month

01

Day

Last follow-up date

2012

Year

04

Month

01

Day

Date of closure to data entry

2012

Year

04

Month

06

Day

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2008

Year

11

Month

13

Day

Last modified on

2013

Year

08

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001775