UMIN-CTR Clinical Trial

Public title

A Phase II trial of combination therapy of gemcitabine and hyperthermia in unresectable pancreatic cancer.

Acronym

Combination therapy of gemcitabine and hyperthermia in unresectable pancreatic cancer.

Scientific Title

A Phase II trial of combination therapy of gemcitabine and hyperthermia in unresectable pancreatic cancer.

Scientific Title:Acronym

Combination therapy of gemcitabine and hyperthermia in unresectable pancreatic cancer.

Region

Japan

Condition

unresectable pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The purpose of this study is to evaluate clinical efficacy and safety of the combination of GEM and hyperthermia in unresectable pancreatic cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

1-year survival rate

Key secondary outcomes

safety, performance status, response rate

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

Maneuver

Interventions/Control_1

One cycle of the chemotherapy regimen consist of a drip infusion of 1000mg/m2 of GEM weekly for 3 weeks and 1 week off, and this was repeated every 4 weeks. Patients receive hyperthermia once per week, each session is scheduled for the day after administratin of GEM, employing radio frequency capacitive heating; Thermotron RF8. The duration of heating session is from 40 minutes to 50 minutes.

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

Eligible criteria in this study are as follows:
1.Histologically confirmed pancreatic cancer
2. Existing measurable lesion(more than two times thickness slice resolution with CT)
3. Over 20 years of age
4. Without active other malignancy
5. No prior treatment(radiation thera
for pancreatic cancer
6. PS is 0, 1 or 2.
7. Sufficient functions of main organ (bone marrow, kidney, heart)
8. Without severe complications or inadequate physical condition, as diagnosed by primary physician
9. Written informed consent

Key exclusion criteria

Exclusion criteria in this study are as follows:
1. Interstitial pneumonitis, pulmonary fibrosis with radiological findings
2. Recurrence after resection for CBD cancer or presence of hepatocellular carcinoma, duodenal cancer, peritonitis carcinomatosa.
3. Presence of ileus
4. Presence of active biliary infection
5. Presence of uncontrolled diabetes, severe liver dysfunction, unstable angina, myocardial infarction within three months.
6. Presence of active severe infection
7. Pregnant, lactating women or women with suspected pregnancy.
8. Medical history of severe hypersensitivity.
9. Severe complications
10. Inappropriate patients for this study judged by the physicians.

Target sample size

18

Name of lead principal investigator

1st name
Middle name
Last name	Toshikazu Yoshikawa

Organization

Graduate School of Medical Science, Kyoto Prefectural University of Medicine

Division name

Molecular Gastroenterology and Hepatology

Zip code

Address

Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan

TEL

075-251-5519

Email

s-kokura@koto.kpu-m.ac.jp

Name of contact person

1st name
Middle name
Last name	Satoshi Kokura

Organization

Graduate School of Medical Science, Kyoto Prefectural University of Medicine

Division name

Molecular Gastroenterology and Hepatology

Zip code

Address

Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan

TEL

075-251-5519

Homepage URL

Email

s-kokura@koto.kpu-m.ac.jp

Institute

Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine

Institute

Department

Personal name

Organization

Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

Hyakumanben clinic

Name of secondary funder(s)

Hyakumanben clinic

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

07

Month

01

Day

URL releasing protocol

Publication of results

Published

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

Completed

Date of protocol fixation

2008

Year

06

Month

13

Day

Date of IRB

Anticipated trial start date

2008

Year

06

Month

01

Day

Last follow-up date

2012

Year

03

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2008

Year

06

Month

30

Day

Last modified on

2015

Year

10

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001455