UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II study of weekly paclitaxel for advanced or recurrent esophageal cancer
Title of the study (Brief title)	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	Atsushi sato
Organization	Hirosaki University Graduate School of Medicine
Division name	Medical Oncology
Address	5 Zaifucho, Hirosaki, Aomori
TEL	0172-39-5346
Email	oncology@hirosaki-u.ac.jp

Public contact
Name of contact person	atsushi sato
Organization	Hirosaki University Graduate School of Medicine
Division name	Medical Oncology
Address	5zaifucho.hirosaki.aomori
TEL	0172-39-5346
Homepage URL
Email	oncology@hirosaki-u.ac.jp

Sponsor
Institute	Medical Oncology, Hirosaki University Graduate School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 01 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011493