UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019230 |
|---|---|
| Receipt number | 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 | 2021/04/09 13:17:44 |
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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 | Ayumu |
| Middle name | |
| Last name | Hosokawa |
Organization
University of Miyazaki Hospital
Division name
Department of Clinical Oncology
Zip code
889-1692
Address
5200 Kihara, Kiyotake, Miyazaki, 889-1692, Japan
TEL
0985-85-9758
ayhosoka@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Ayumu |
| Middle name | |
| Last name | Hosokawa |
Organization
University of Miyazaki Hospital
Division name
Department of Clinical Oncology
Zip code
889-1692
Address
5200 Kihara, Kiyotake, Miyazaki, 889-1692, Japan
TEL
0985-85-9758
Homepage URL
ayhosoka@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki Hospital
Institute
Department
Personal name
Funding Source
Organization
University of Miyazaki 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
University of Miyazaki Hospital, Clinical Research Support Center
Address
5200 Kihara, Kiyotake, Miyazaki, 889-1692, Japan
Tel
0985-85-9010
igakubu_kenkyu@med.miyazaki-u.ac.jp
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
25
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
| 2015 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
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
| 2021 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022223
