UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009807
Receipt number R000011493
Scientific Title A phase II study of weekly paclitaxel for advanced or recurrent esophageal cancer
Date of disclosure of the study information 2013/01/21
Last modified on 2017/04/03 09:14:53

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

A phase II study of weekly paclitaxel for advanced or recurrent esophageal cancer

Acronym

Second line treatment using weekly paclitaxel for esophageal cancer

Scientific Title

A phase II study of weekly paclitaxel for advanced or recurrent esophageal cancer

Scientific Title:Acronym

Second line treatment using weekly paclitaxel for esophageal cancer

Region

Japan


Condition

Condition

advanced or reccurent esophageal cancer

Classification by specialty

Gastroenterology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of weekly paclitaxel in patients with advanced or recurrent esophageal cancer.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

response rate

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Paclitaxel (100mg/m2) is administered intravenously over 1 h on days 1, 8 and 15 of each 4-week period.

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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

older than 20 years of age with histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the esophagus, and who had received at least one regimen of platinum-based chemotherapy
advanced (stage IV) or recurrent (after chemotherapy, surgery or radiotherapy) disease
previous platinum-based chemotherapy could have occurred in the adjuvant or neoadjuvant setting, or in combination with radiotherapy
patients had either failed or progressed (stage IV) following platinum-based therapy, or had discontinued due to toxicity
patients with measurable disease
ECOG PS of 0 or 1, and a life expectancy of 3 months
treatment interval longer than 3 weeks adequate functioning of major organ systems as indicated by the following laboratory parameters: neutrophils >=1,500/mm3; platelets >=100,000/mm3; hemoglobin >=9 g/dL; ALT and AST levels <=100 IU/L; total bilirubin <=1.5 mg/dL; and serum creatinine <=1.5 mg/dL
written informed consent was obtained from all patients

Key exclusion criteria

severe bone marrow suppression
active infection
uncontrolled comorbidities
acute inflammatory disease
interstitial pneumonia or pulmonary fibrosis
symptomatic metastases of the central nervous system
with a history of allergic reaction to polyoxyethylene-castor oil
under administration of disulfiram, cyanamide and procarbazine hydrochloride
pregnant or nursing woman
any patients judged by the investigator to be unfit to participate in the study

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Atsushi sato

Organization

Hirosaki University Graduate School of Medicine

Division name

Medical Oncology

Zip code


Address

5 Zaifucho, Hirosaki, Aomori

TEL

0172-39-5346

Email

oncology@hirosaki-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name atsushi sato

Organization

Hirosaki University Graduate School of Medicine

Division name

Medical Oncology

Zip code


Address

5zaifucho.hirosaki.aomori

TEL

0172-39-5346

Homepage URL


Email

oncology@hirosaki-u.ac.jp


Sponsor or person

Institute

Medical Oncology,
Hirosaki University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Medical Oncology,
Hirosaki University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2013 Year 01 Month 21 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Completed

Date of protocol fixation

2013 Year 01 Month 18 Day

Date of IRB


Anticipated trial start date

2013 Year 01 Month 21 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 01 Month 18 Day

Last modified on

2017 Year 04 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011493


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name