UMIN-CTR Clinical Trial

Public title

A Randomised Phase II trial investigating the duration of adjuvant therapy(6 versus 12 months) with S-1 for patients after resection of pancreatic cancer

Acronym

Postoperative Adjuvant Chemotherapy S-1 : PACS-1

Scientific Title

A Randomised Phase II trial investigating the duration of adjuvant therapy(6 versus 12 months) with S-1 for patients after resection of pancreatic cancer

Scientific Title:Acronym

Postoperative Adjuvant Chemotherapy S-1 : PACS-1

Region

Japan

Condition

Resected pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the efficacy and safety of the duration of adjuvant therapy (6 versus 12 months) with S-1 for patients after resection of pancreatic cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

2-year overall survival rate

Key secondary outcomes

DFS, OS, Dose Intensity, Complete rate of each treatment point (3 and 6, 9, 12 months), Safety

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

S-1 40 mg/m2 is given orally twice a day for four weeks, followed by a two-week rest. This course is repeated until 6 months or to meet discontinuation criteria.

Interventions/Control_2

S-1 40 mg/m2 is given orally twice a day for four weeks, followed by a two-week rest. To be repeated until 12 months or to meet discontinuation criteria.

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) Patients with written informed consent
2) Patients who are judged to be suitable for receiving this protocol therapy by the physician
3) Resected cases with histologically proven invasive ductal carcinoma of the pancreas
4) According to the UICC 7th classification;
- Stage I or II, or III in whom celiac artery resection was performed
- R0 or R1
- Cancer negative for washing cytology of the abdominal cavity
5) No distant metastasis nor malignant ascites
6) Adequate oral intakes
7) Aged 20 years and older
8) An Eastern Cooperative Oncology Group performance status of 0 or 1
9) No prior history of chemotherapy nor radiation therapy within three years
10) Within 10 weeks after operation
11) Sufficient organ function of bone marrow, liver, and kidney:
12) Patients with laboratory data within 14days before enrollment as follows;
Leukocytes >= 3,000 /mm3 and <= 12,000 /mm3, Platelets >= 100,000 /mm3, Hemoglobin >= 8.0 g/dL, Serum total bilirubin <= 2.0 mg/dL, Serum aspartate aminotransferase (AST) <= 100 IU/L, Serum alanine aminotransferase (ALT) <= 100 IU/L, and Serum creatinine <= 1.2 mg/dL

Key exclusion criteria

1) Previously treated by chemotherapy for locally advanced pancreatic cancer
2) Prior history of S-1 therapy
3) History of serious drug hypersensitivity or a history of drug allergy
4) Patients with contraindication for the medication of S-1
5) Serious complications ( ex. interstitial pneumonitis, pulmonary fibrosis, renal failure, liver failure, intractable diabetes, intractable hypertension)
6) Recurrent disease before enrollment
7) Moderate or ascites or pleural effusion
8) Plumonary fibrosis or interstitial pneumonia diagnosed by chest X-ray.
9) Serious diarrhea
10) Myocardial infarction within six months
11) Active infection(fever up; over 38 degree)
12) Blood transfusion within 2 weeks before enrollment
13) Severe mental disorder
14) Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free survival of 5 years or less).
15) Pregnant or lactating woman and man who hope for partner&#39;s pregnancy
16) Patients who need flucytosine, phenytoin or warfarin potassium.
17) Requiring continous steroid administration
18) Not appropriate for the study at the physician&#39;s assessment

Target sample size

170

Name of lead principal investigator

1st name
Middle name
Last name	Yoshihiko MAEHARA

Organization

Graduate School of Medical Sciences, Kyushu University

Division name

Department of Surgery and Science

Zip code

Address

3-1-1, Maidashi, Higashi-Ku, Fukuoka 812-8582, Japan

TEL

092-642-5466

Email

abesato@surg2.med.kyushu-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Norifumi HARIMOTO

Organization

Graduate School of Medical Sciences, Kyushu University

Division name

Department of Surgery and Science

Zip code

Address

3-1-1, Maidashi, Higashi-Ku, Fukuoka 812-8582, Japan

TEL

092-642-5466

Homepage URL

Email

abesato@surg2.med.kyushu-u.ac.jp

Institute

Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

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

九州大学病院（福岡県）、済生会福岡総合病院（福岡県）、九州中央病院（福岡県）、九州がんセンター（福岡県）、福岡市民病院（福岡県）、飯塚病院（福岡県）、大分赤十字病院（大分県）、大分県立病院（大分県）、別府医療センター（大分県）、熊本大学大学院生命科学研究部（熊本県）、済生会熊本病院（熊本県）、広島赤十字・原爆病院（広島県）、徳島大学大学院ヘルスバイオサイエンス研究部（徳島県）、松山赤十字病院（愛媛県）、東京慈恵会医科大学（東京都）、群馬大学大学院（群馬県）

Date of disclosure of the study information

2013

Year

12

Month

20

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

No longer recruiting

Date of protocol fixation

2013

Year

12

Month

16

Day

Date of IRB

Anticipated trial start date

2013

Year

12

Month

20

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

12

Month

20

Day

Last modified on

2017

Year

06

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014772