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 |
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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
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
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
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
