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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000019230
Receipt No. R000022223
Scientific Title A phase II study of weekly paclitaxel in patients with advanced or recurrent esophageal cancer who had previously received docetaxel-containing chemotherapy
Date of disclosure of the study information 2015/10/13
Last modified on 2018/10/08

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Basic information
Public title A phase II study of weekly paclitaxel in patients with advanced or recurrent esophageal cancer who had previously received docetaxel-containing chemotherapy
Acronym A phase II study of weekly paclitaxel in patients with advanced or recurrent esophageal cancer who had previously received docetaxel-containing chemotherapy
Scientific Title A phase II study of weekly paclitaxel in patients with advanced or recurrent esophageal cancer who had previously received docetaxel-containing chemotherapy
Scientific Title:Acronym A phase II study of weekly paclitaxel in patients with advanced or recurrent esophageal cancer who had previously received docetaxel-containing chemotherapy
Region
Japan

Condition
Condition Advanced or recurrent esophageal cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of weekly paclitaxel in patients with advanced or recurrent esophageal cancer who had previously received docetaxel-containing chemotherapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes Overall survival, progression-free survival, adverse events

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, 1-h intravenous infusion) is administered on day1, 8, 15, 22, 29 and 36, repeated every 7 weeks.
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 1)Histologically confirmed squamous cell carcinoma or adenosquamous cell carcinoma of the esophagus
2)Advanced (stage IV) or recurrent esophageal cancer who had previously received docetaxel-containing chemotherapy
3)Adequate recovery from prior systemic therapy as follows: >=4 weeks post-radiation therapy; >=4 weeks post-chemotherapy and surgical therapy; >=2 weeks post-treatment with antimetabolic drugs
4)Patients with measurable lesions
5)ECOG performance status of 0 to 1
6)Adequate organ functioing of major organ systems as indicated by the following laboratory parameters: neutrophils >=1,500/mm3; platelets>=100,000/mm3; hemoglobin>=9.0g/dL; AST and ALT levels<=100IU/L; total bilirubin <=1.5mg/dL; and serum creatinin <=2.0mg/dL
7)A life expectancy of >=2 months
8)Age 20 years old or more
9)HBs antigen negative
10)Written informed consent
Key exclusion criteria 1)Pregnant or lactating women
2)Symptomatic brain metastasis
3)Synchronous or metachronous (within 5 years) malignancies except for mucosal tumors of gastrointestinal tract
4)Severe complications (serious cerebrovascular disorders, uncontrollable hypertension, uncontrollable diabetes mellitus, active ulceration)
5)Active bacterial or fungous infection
6)Interstitial pneumonitis or pulmonary fibrosis
7)Massive pleural effusion or massive ascites
8)Past histrory of myocardial infarction and angina attack within 6 months
9)Past histrory of congested heart failure
10)Arhythmia requiring treatment
11)Peripheral neuropathy grade >=2 by CTCAE v4.0
12)With a history of allergic reaction to polyoxyethylene castor oil or hydrogenated castor oil
13)Serious psychiatric disease
14)Systemic steroids medication
Target sample size 44

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ayumu Hosokawa
Organization Miyazaki University Hospital
Division name Department of Clinical Oncology
Zip code
Address 5200 Kihara, Kiyotake, Miyazaki, 889-1692, Japan
TEL 0985-85-9758
Email ayhosoka@med.miyazaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ayumu Hosokawa
Organization Miyazaki University Hospital
Division name Department of Clinical Oncology
Zip code
Address 5200 Kihara, Kiyotake, Miyazaki, 889-1692, Japan
TEL 0985-85-9758
Homepage URL
Email ayhosoka@med.miyazaki-u.ac.jp

Sponsor
Institute Miyazaki University Hospital
Institute
Department

Funding Source
Organization Miyazaki University Hospital
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
2015 Year 10 Month 13 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 Open public recruiting
Date of protocol fixation
2015 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 01 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
2015 Year 10 Month 04 Day
Last modified on
2018 Year 10 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022223

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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