UMIN-CTR Clinical Trial

Public title

The multicenter observational study of systemic chemotherapy for gastrointestinal and hepatobiliary-pancreatic poorly differentiated neuroendocrine carcinoma.

Acronym

The multicenter observational study of systemic chemotherapy for gastrointestinal and hepatobiliary-pancreatic poorly differentiated neuroendocrine carcinoma.

Scientific Title

The multicenter observational study of systemic chemotherapy for gastrointestinal and hepatobiliary-pancreatic poorly differentiated neuroendocrine carcinoma.

Scientific Title:Acronym

The multicenter observational study of systemic chemotherapy for gastrointestinal and hepatobiliary-pancreatic poorly differentiated neuroendocrine carcinoma.

Region

Japan

Condition

gastrointestinal and hepatobiliary-pancreatic poorly differentiated neuroendocrine carcinoma

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the outcome of systemic chemotherapy for poorly differentiated neuroendcrine carcinoma

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Primary outcomes

Response rate

Key secondary outcomes

Progression-free survival, Overall survival, Time to progression

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

* The poorly-differentiated neuroendocrine carcinoma arising from esophagus,stomach, duodenum, colorectum, liver, biriary tract, or pancreas.
* Chemotherapy was performed for poorly-differentiated neuroendocrine carcinoma.

Key exclusion criteria

malignant carcinoid
insulinoma, gastrinoma, VIPoma
islet cell carcinoma

Target sample size

300

Name of lead principal investigator

1st name
Middle name
Last name	Chigusa Morizane

Organization

National Cancer Center Hospital,Tokyo,Japan

Division name

Division of Hepatobiliary and Pancreatic Oncology

Zip code

Address

5-1-1 Tsukiji, Chuo-ku, Tokyo

TEL

Email

Name of contact person

1st name
Middle name
Last name	Tomohiro Yamaguchi

Organization

National Cancer Center Hospital ,Tokyo,Japan

Division name

Division of Hepatobiliary and Pancreatic Oncology

Zip code

Address

TEL

Homepage URL

Email

toyamagu@ncc.go.jp

Institute

National Cancer Center Hospital-TOKYO

Institute

Department

Personal name

Organization

Cancer Research and development fund.

Organization

Division

Category of Funding Organization

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

2011

Year

03

Month

04

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

2011

Year

02

Month

01

Day

Date of IRB

Anticipated trial start date

2011

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

Results
This study included 258 patients (males/females, 182/76) with median age of 62.5 years.
Primary sites were esophagus/stomach/small bowel/colorectum/hepato-biliary system/
pancreas in 85/70/6/31/31/35 patients (pts). According to the primary sites, the median overall
survival period (mOS) was 13.4/13.3/29.7/7.6/7.9/8.5 months, and that of GI/HBP was 13.0/7.9
months, respectively. Most common regimen was IP (160 pts, 62%), followed by EP (46 pts,
18%). For IP/EP patients, response rates (RR) were 50%/27%, the median progression free
survival periods (mPFS) were 5.2/4.0 months. Second line chemotherapy was performed for
88 pts (55%)/28 pts (61%), and mOS from first line Cx were 13.0/7.3 months in IP/EP groups.
Multivariate analysis demonstrated that a primary site of HBP (HR=1.96, p=0.003), and
Performance status> 2 (HR=2.32, p=0.01) were independent unfavorable prognostic factors of
PDNEC patients treated with systemic chemotherapy, while the hazard ratio comparing IP with
EP was 0.79 (p=0.305).
Conclusions
PDNEC of HPB had poorer prognosis than GI. IP was the most common treatment regimen,
and seemed to show better treatment outcomes than EP.

Registered date

2011

Year

03

Month

03

Day

Last modified on

2012

Year

09

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006148