UMIN-CTR Clinical Trial

Public title

Randomized phase II trial of TS-1 monotherapy versus TS-1 plus gemcitabine therapy in patients with gemcitabine-resistant advanced pancreatic cancer

Acronym

KCGCOR-1

Scientific Title

Randomized phase II trial of TS-1 monotherapy versus TS-1 plus gemcitabine therapy in patients with gemcitabine-resistant advanced pancreatic cancer

Scientific Title:Acronym

KCGCOR-1

Region

Japan

Condition

Patients with unresectable advanced pancreatic cancer (Stage IV, TNM Classification) who were primarily resistant to gemcitabine monotherapy

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To investigate the efficacy and safety of TS-1 therapy and TS-1 plus gemcitabine combination therapy as a second-line chemotherapy for advanced pancreatic cancer (Stage IV, TNM Classification) who were resistant to gemcitabine as a first-line chemotherapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

disease control rate

Key secondary outcomes

progression-free survival, overall survival, adverse event, QOL

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

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Arm 1: S-1 monotherapy
Patients who enrolled this study will receive either arm of the therapy 3 weeks after their prior treatment has finished. In the S-1 arm, S-1 is given orally for four weeks, followed by a 2-week rest. as two divided doses (after breakfast and dinner), determined according to body surface area (BSA): BSA below 1.25 m2, 80 mg; 1.25 to 1.5 m2, 100 mg and BSA over1.5 m2, 120 mg. This course is repeated until progressive disease or severe toxicities are confirmed.

Interventions/Control_2

Arm 2: S-1/Gem
Patients who enrolled this study will receive either arm of the therapy 3 weeks after their prior treatment has finished. In the S-1/Gem arm, Gemcitabine (1000 mg/m2) is given by intravenous infusion over 30 minutes on days 8 and 15, followed by a 1-week rest. However, if the dose is reduced in patients during the first-line chemotherapy, administration should be started after reducing the dose of gemcitabine to 800 mg/m2.
S-1 is given orally for two weeks from Day 1 to 14, followed by a 1-week rest. as two divided doses (after breakfast and dinner), determined according to body surface area (BSA): BSA below 1.25 m2, 60 mg; 1.25 to 1.5 m2, 80 mg and BSA over1.5 m2, 100 mg.
This course is repeated until progressive disease or severe toxicities are confirmed.

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

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

Eligible criteria in this study are as follows:
1)Cases with clinically proven carcinoma of the pancreas
2) Stage IV (TMN classification, UICC) unresectable patients.
3) Ages between 20 to 80 years old
4) An Eastern Cooperative Oncology Group performance status of 0 or 1. (Karnofsky performance status (KPS) of 70%)
5) Patients with solid tumor(s) which can be evaluated by Response Evaluation Criteria in Solid Tumours (RECIST) guidelines
6) Patients who previously had received gemcitabine monotherapy as the first-line chemotherapy and had been diagnosed as Progressive Disease (PD)
7) patients who experienced grade 4 hematologic toxicity are ineligible.
8) Patients must not have received any chemotherapy or radiotherapy for 3 weeks before entering this study
9) prior dose of the gemcitabine in the past chemotherapy>= 800 mg/m(2)
10) patients who are capable of oral intake.
11) Sufficient organ function within 1-week from the enrollment:
leukocytes >= 3,500 /mm3 and <= 12,000 /mm3, neutriphils >= 2,000 /mm3, platelets >= 100,000 /mm3, hemoglobin >= 9.0 g/dL, serum total bilirubin <= 2 times from upper normal value of the facility, serum aspartate aminotransferase (AST) <= 2.5 times from upper normal value of the facility, serum alanine aminotransferase (ALT) <= 2.5 times from upper normal value of the facility, creatinin clearance>=60 mL/mil
12) Written informed consent

Key exclusion criteria

Exclusion criteria are as follows:
1) Prior history of radiation therapy to pancreatic cancer
2) Presence of other active malignancy
3) Presence of severe complications such as plumonary fibrosis, interstitial pneumonia, intestinal paralysis, uncontrolled diabetes, uncontrolled hypertension, myocardial infarction within six months, unstable angina, severe infection, renal failure, liver failure, , etc
4) Past history of allergic reaction to gemcitabine
5) Regular use of frucitocin, fenitoin or warfarin
6) Past history of radiation therapy to the lung(s).
7) Massive ascites or pleural effusion
8) Severe diarrhea
9) active intestinal bleeding
10) Pregnancy, breast feeding, or women who desire to preserve fecundity or men who desire to have children
11) Severe mental disorder
12) regular use of steroids
13) Inadequate physical condition, as diagnosed by primary physician

Target sample size

80

Name of lead principal investigator

1st name
Middle name
Last name	Toshifumi Hibi, MD

Organization

Keio University School of Medicine, Department of Medicine

Division name

Gastroenterology

Zip code

Address

35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan

TEL

03-3353-1211

Email

Name of contact person

1st name
Middle name
Last name	Masayuki Adachi, MD

Organization

Keio University School of Medicine, Department of Medicine

Division name

Gastroenterology

Zip code

Address

35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan

TEL

03-3353-1211

Homepage URL

Email

adachi@sc.itc.keio.ac.jp

Institute

Keio University School of Medicine, Department of Medicine, Division of Gastroenterology

Institute

Department

Personal name

Organization

Keio University School of Medicine

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

Date of disclosure of the study information

2008

Year

04

Month

01

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

Date of protocol fixation

2007

Year

11

Month

12

Day

Date of IRB

Anticipated trial start date

2007

Year

11

Month

01

Day

Last follow-up date

2011

Year

04

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2008

Year

03

Month

28

Day

Last modified on

2008

Year

03

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001295