UMIN-CTR Clinical Trial

Public title

Phase II trial of weekly Nab-Paclitaxel as second-line chemotherapy for unrecectable or recurrent advanced gastric cancer.

Acronym

Phase II trial of weekly Nab-Paclitaxel as second-line chemotherapy for unrecectable or recurrent advanced gastric cancer.

Scientific Title

Phase II trial of weekly Nab-Paclitaxel as second-line chemotherapy for unrecectable or recurrent advanced gastric cancer.

Scientific Title:Acronym

Phase II trial of weekly Nab-Paclitaxel as second-line chemotherapy for unrecectable or recurrent advanced gastric cancer.

Region

Japan

Condition

Advanced Gastric Cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the safty and effectivity of weekly nab-paclitaxel as second-line chemotherapy for unrecectable or recurrent advanced gastric cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Response rate (RR)

Key secondary outcomes

Overall survival(OS),Progression free survival(PFS),Time to progression(TTP),Safty

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

Nab-paclitaxel 100mg/m2 is administered by an infusion lasting 30 minutes on days 1, 8,15 every 4weeks untile PD.

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 proven gastric adenocarcinoma
2) Patients with prior on chemotherapy incuding fluoropyrimydine (including recurrence within 6 months after last adjuvant chemotherapy)
3) With measurable lesions within 28 days before registration
4) Patients with advanced/recurrent gastric cancer which are resistant to chemotherapy within 28 days before registration
5) ECOG performance status 0, 1 or 2
6) Older than 20 years
7) With longer than 3 months of expected survival at the registration
8) Days before enrollment
More than 4 weeks last radiation therapy
More than 2 weeks last surgery
More than 2 weeks last chemotherapy
More than 2 weeks last immunotherapy
More than 4 weeks last investigational drug
9) Days before enrollment
Leukocyte count =>3,000 /mm3,=< 12000/mm3
Neutrophil count =>1,500/mm3
Platelet count => 100,000/mm3
Hemoglobin => 9.0 g/dL
Total bilirubin =<1.5 mg/dL
AST and ALTx2.5 of upper limit of normal (ULN) or less
Serum creatinine =<1.5 mg/dL
10) Patients were not received a blood transfusion within 14 day before enrollment
11) Written informed consent

Key exclusion criteria

1) With history of receiving paclitaxel treatment
2) With peripheral neuropathy greater than Grade2
3) With serious drug allergy
4) With infectious disease and febrile condition (over 38 centigrade)
5) With active double cancers excluding carcinoma in situ and/or prior cancer cured with longer than 5 year interval period
6) With brain metastasis
7) With severe diseases: infectious disease/ uncontrolled DM /poorly controlled hypertension/ myocardial infarction/liver failure/pneumonia or pulmonary fibrosis
8) pregnant or nursing female or male expecting pregnancy of partner
9) Psychological illness
10) Any other patients whom the physician in charge of the study judges to be unsuitable

Target sample size

35

Name of lead principal investigator

1st name
Middle name
Last name	Masahide Ikeguchi

Organization

Tottori University Faculty of Medicine

Division name

Department of Surgery Division of Surgical oncology

Zip code

Address

36-1 Nishi, Yonago, Tottori, 683-8504, Japan

TEL

0859-38-6567

Email

masaike@med.tottori-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Hiroaki Saitoh

Organization

Tottori University Faculty of Medicine

Division name

Department of Surgery Division of Surgical oncology

Zip code

Address

36-1 Nishi, Yonago, Tottori, 683-8504, Japan

TEL

0859-38-6567

Homepage URL

Email

sai10@med.tottori-u.ac.jp

Institute

Tottori University

Institute

Department

Personal name

Organization

No

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

2014

Year

12

Month

16

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

2014

Year

04

Month

01

Day

Date of IRB

Anticipated trial start date

2014

Year

10

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

12

Month

16

Day

Last modified on

2014

Year

12

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018498