UMIN-CTR Clinical Trial

Public title

A clinical phase-II trial of neoadjuvant chemoradiotherapy with S-1 and Gemcitabine for locally advanced pancreatic cancer (PerSeUS-GP02)

Acronym

PerSeUS-GP02

Scientific Title

A clinical phase-II trial of neoadjuvant chemoradiotherapy with S-1 and Gemcitabine for locally advanced pancreatic cancer (PerSeUS-GP02)

Scientific Title:Acronym

PerSeUS-GP02

Region

Japan

Condition

Locally advanced pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate efficacy and safety of neoadjuvant chemoradiotherapy with S-1 and Gemcitabine for locally advanced pancreatic cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

1-year survival rate

Key secondary outcomes

Progression free survival
Surgical resection rate
Curative resection rate
Response rate
Safety

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

After chemoradiation therapy with S-1 and Gemcitabine, surgical resection is carried out.
Post operative chemotherapy with S-1 is continued for 1 year.

S-1; 80mg/m2/day (administration on the day of radiation therapy)
Gemcitabine; 1000mg/m2/day, day1, 15, 29
Radiation therapy; a total dose of 39.6Gy by 22 fractions.
Post operative chemotherapy with S-1:
S-1; 80mg/m2 administration for 14 days, followed by a resting period for 7 days.

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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Histologically, cytologically or radiographically proven pancreatic cancer
2. Stage IVa borderline resectable pancreatic cancer defined in NCCN guidelines 2012 pancreatic adenocarcinoma
3. At least one measurable lesion
4. No prior history of the treatment such as surgical operation, radiotherapy, and chemotherapy for the lesion
5. ECOG performance status of 0-1.
6. Adequate oral intakes
7. Sufficient organ function:
Leukocytes: >= 3,500/mm3
Neutrophil: >= 2,000/mm3
Platelets: >= 100,000/mm3
Hemoglobin: >= 9g/dL
Serum total bilirubin: <= 2.0mg/dL (or 3.0mg/dL in cases after biliary drainage)
Serum transaminases: AST <= 100U/L (or 150U/L in cases after biliary drainage), ALT <= 100U/L (or 150U/L in cases after biliary drainage)
Serum creatinine: <= 1.2mg/dL
Creatinine clearance: >= 50ml/min (option)
8. Life expectancy of more than 3 months
9. Written informed consent

Key exclusion criteria

1. Lung fibrosis or interstitial pneumonia. (should be confirmed by chest radiograph or CT within 28 days before the entry)
2. Watery diarrhea or chronic diarrhea
3. Regular use of Fenitoin, Warfarin or Frucitocin
4. Pleural effusion or ascites
5. Active infection
6. Other malignancies
7. Active gastroduodenal ulcer
8. Serious comorbid illness (heart failure, renal failure, liver failure, intestinal paralysis, uncontrolled diabetes, etc)
9. Serious mental disorder
10. Serious drug allergy
11. Pregnancy, breast feeding, or women who desire to preserve fecundity. Men who want his partner to be pregnant.
12. Patients who were judged inappropriate for the entry to this study by the investigators

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Hisataka Moriwaki

Organization

Gifu University graduate school of medicine

Division name

Department of Gastroenterology

Zip code

Address

1-1 Yanagido, Gifu city

TEL

058-230-6308

Email

Name of contact person

1st name
Middle name
Last name	Ichiro Yasuda

Organization

Gifu University graduate school of medicine

Division name

Department of Gastroenterology

Zip code

Address

1-1 Yanagido, Gifu city

TEL

058-230-6308

Homepage URL

Email

Institute

PerSeUS: Perpetual Study estimated-by United Sections in gifu

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Gifu Prefectural Medical Center
Gifu Municipal Hospital

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

岐阜大学医学部附属病院（岐阜）
岐阜県総合医療センター（岐阜）
岐阜市民病院（岐阜）

Date of disclosure of the study information

2013

Year

04

Month

06

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2013

Year

04

Month

06

Day

Date of IRB

Anticipated trial start date

2013

Year

04

Month

12

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

04

Month

06

Day

Last modified on

2013

Year

04

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012201