UMIN-CTR Clinical Trial

Public title

A phase II study of low dose nab-paclitaxel as second-line chemotherapy for unresectable or recurrent gastric cancer

Acronym

A phase II study of nab-paclitaxel as second-line chemotherapy for gastric cancer

Scientific Title

A phase II study of low dose nab-paclitaxel as second-line chemotherapy for unresectable or recurrent gastric cancer

Scientific Title:Acronym

A phase II study of nab-paclitaxel as second-line chemotherapy for gastric cancer

Region

Japan

Condition

unresectable or recurrent gastric cance

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

To evaluate the efficacy and the safety of low dose nab-paclitael as second line chemotheray for metastatic or recurrent gastric cancer.
And, to explore the correlation between SPARC expression and the efficacy as biomarker for nab-paclitaxel.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

RR

Key secondary outcomes

OS, DFS, DCR, Safety, Dose-Intensity, Correlation between SPARC expression and efficacy, QOL

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

Low dose nab-Paclitaxel is administered tri-weekly.

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. Histopathologically confirmed gastric cancer.
2. Patients with measurable lesions within 28 days before registration.
3. Patients resisted first line chemotherapy consisted of fluoropyrimidine for unresectable or reccurent gastric cancer.
4. Patients with advanced/recurrent gastric cancer which are resistant to first line chemotherapy within 28 days before registration.
5. No influence of prior therapy.
6. PS 0-2
7. Age >=20
8. Expected more than 3 months survival
9. Adequate organ functions (within 14 days before registration)
Leu: >=3,000 /mm3, <=12,000 /mm3
Neu: >= 1,500 /mm3
Plt: >= 100,000 /mm3
Hemoglobin: >= 9.0 g/dL
ALT: <=ULNx2.5
AST: <=ULNx2.5
T-bil: =<1.5mg/dl
Scr: >= 1.5 mg/dl
10. With written informed consent

Key exclusion criteria

1. Patients with serious drug allergy
2. Patients with history of receiving paclitaxel treatment
3. Patients with infectious disease and febrile condition (over 38 centigrade)
4. Patiens with any other serious disease.
5. Patients with severe diarrhea
6. Patients with fresh bleeding from intestinal tract.
7. Patients with serious heart disease
8. Presence of active multiple primaries. (Active multiple primaries is simultaneous or metachronous with disease-free interval of 5 years or more. But, carcinoma in situ and skin cancer which are judged to be recovery by medical treatment are excluded.)
9. Patients with peripheral neuropathy(=>Grade2)
10. Patients wit psychological illness
11. Pregnant or nursing female
12. Patient with brain metastasis.
13. Not appropriate for the study at the physician's assessment

Target sample size

37

Name of lead principal investigator

1st name
Middle name
Last name	Shigefumi Yoshino

Organization

Yamaguchi University Graduate School of Medicine

Division name

Department of Digestive Surgery and Surgical Oncology

Zip code

Address

1-1-1 Minamikokushi, Ube, Yamaguchi 755-8505, Japan

TEL

0836-22-2264

Email

sigefumi@yamaguchi-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Shigefumi Yoshino

Organization

Yamaguchi University Graduate School of Medicine

Division name

Department of Digestive Surgery and Surgical Oncology

Zip code

Address

1-1-1 Minamikokushi, Ube, Yamaguchi 755-8505, Japan

TEL

0836-22-2264

Homepage URL

Email

sigefumi@yamaguchi-u.ac.jp

Institute

Department of Digestive Surgery and Surgical Oncology, Yamaguchi University Graduate School of Medicine

Institute

Department

Personal name

Organization

Department of Digestive Surgery and Surgical Oncology, Yamaguchi University Graduate 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

2015

Year

01

Month

13

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

Preinitiation

Date of protocol fixation

2015

Year

01

Month

10

Day

Date of IRB

Anticipated trial start date

2015

Year

02

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

2015

Year

01

Month

13

Day

Last modified on

2015

Year

01

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018775