UMIN-CTR Clinical Trial

Public title

Efficacy and safety of nab-paclitaxel plus carboplatin in patients with Carcinoma of unknown primary site

Acronym

Efficacy and safety of CBDCA plus nab-PTX in patients with CUP

Scientific Title

Efficacy and safety of nab-paclitaxel plus carboplatin in patients with Carcinoma of unknown primary site

Scientific Title:Acronym

Efficacy and safety of CBDCA plus nab-PTX in patients with CUP

Region

Japan

Condition

Carinoma of unknown primary site(CUP)

Classification by specialty

Medicine in general

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Patients with cancer of unknown primary site(CUP) are treated by a combination chemotherapy of nab-paclitaxel and carboplatin(CBDCA) as a first-line chemotherapy. We analyze the efficacy(1-year survival rate,RR, PFS, OS) and safety.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

1-year survival rate

Key secondary outcomes

progression free survival, overall survival,response rate,tumor control rate,adverse event,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

Nab-paclitaxel is administered as a 30-minute infusion at a dose of 100mg/m2 on days 1,8,and 15 followed by carboplatin at an AUC of5 mg.min/ml(per Calvert formula) given on day1, every 21 days. Responding patients and patients with stable disease have a four-cycle minimum.

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)Patients with histologically comfirmed metastatic malignant lesion, with no identifiable primary site by physical examination, imaging, and laboratory examination.
2)No prior chemotherapy for CUP
3)Patients should be 20 years or older at informed consent.
4)ECOG PS scale: 0-2
5)Patient with enough feasibility for planned chemotherapy(hematological, liver, renal, cardiopulmonary function).
6)Written informed consent.

Key exclusion criteria

1)Indication for radical operation and radiotherapy.
2)Patients unable to take nab-paclitaxel and CBDCA because of significant cardiovascular abnormalities, renal dysfunctions, hepatic insufficiency, uncontrolled diabetes, uncontrolled hypertension, bleeding tendency, active interstitial pneumonia,etc.
3)Known active brain metastasis.
4)Acute or subacute idiopathic interstitial pneumonia
5)Patient received a bone-marrow transplantation
6)Patient received a peripheral stem cell transplantation
7)Known hypersensitivity to any drugs
8)Seropositivity for HBsAg
9)Pregnancy or breast feeding.

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Nobuhiko Seki

Organization

Teikyo University School of Medicine

Division name

Division of Medical Oncology,Department of Internal Mediine

Zip code

Address

2-11-1 Kaga,Itabashi-ku,Tokyo,JAPAN

TEL

03-3964-1211

Email

nseki@med.teikyo-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Yasuko Ichikawa

Organization

Teikyo University School of Medicine

Division name

Division of Medical Oncology,Department of Internal Mediine

Zip code

Address

2-11-1 Kaga,Itabashi-ku,Tokyo,JAPAN

TEL

03-3964-1211

Homepage URL

Email

icchi@med.teikyo-u.ac.jp

Institute

Teikyo University School of Medicine

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

JAPAN

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

03

Month

06

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

10

Month

15

Day

Date of IRB

Anticipated trial start date

2015

Year

01

Month

13

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

03

Month

06

Day

Last modified on

2015

Year

03

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018725