UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008574 |
|---|---|
| Receipt number | R000010053 |
| Scientific Title | A prospective clinical study to evaluate the feasibility and safeness of the chemotherapy with weekly paclitaxel administration in cases with anaplastic thyroid cancer |
| Date of disclosure of the study information | 2012/07/31 |
| Last modified on | 2014/07/30 13:05:12 |
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Basic information
Public title
A prospective clinical study to evaluate the feasibility and safeness of the chemotherapy with weekly paclitaxel administration in cases with anaplastic thyroid cancer
Acronym
ATCCJ-TXL-P2
Scientific Title
A prospective clinical study to evaluate the feasibility and safeness of the chemotherapy with weekly paclitaxel administration in cases with anaplastic thyroid cancer
Scientific Title:Acronym
ATCCJ-TXL-P2
Region
| Japan |
Condition
Condition
anaplastic thyroid cancer
Classification by specialty
| Endocrinology and Metabolism | Hematology and clinical oncology | Surgery in general |
| Endocrine surgery | Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility and the safeness to perform the chemotherapy with weekly paclitaxel administration for the patients with anaplastic thyroid cancer. Efficacy of the treatment will be evaluated in cases with evaluable lesion.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relative dose intensity and safety of the chemotherapy will be evaluated.
Overall response rate, time to failure, type of recurrence, overall survival.
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
Chemotherapy with weekly paclitaxel administration. 80mg/m2 once every week. One course consisted of 3 administrations. At least 1 course of the therapy is necessary. Therapy may continue when available.
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
Patient who fulfills all following criterion.
(1) pathologically proven anaplastic thyroid cancer
(2) aged 20 and over
(3) ECOG performance status 0-2
(4) suffient organ function(e.g. marrow,liver, kidney,bone)
(5) written informed consent
Key exclusion criteria
Patient who matches one of these criterion.
(1) suspision for interstitial pneumonia or pulmonary fibrosis by chest radiograph
(2) brain metastasis with symptom
(3) presence of the active peptic ulcer
(4) presence of the active other malignancies
(5) fever more than 38C
(6) severe complication (e.g. myocardial infarction within 3 months, heart failure with clinically problem, poorly controlled diabetes mellitus, severe infectious disease.
(7) past history for severe drug allergy
(8) past history of hypersisitivity to polyoxyethylated or hydrogenated castor oil
(9) hypersisitivity to alcohol
(10) pregnant or nursing women
(11) difficult to entry due to psychological problem
(12) previous chemotherapy or radiation therapy to the present illness
(13) physician judged improper to entry this trial
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoyoshi Onoda |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Surgical Oncology
Zip code
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL
+81-06-6645-3838
nonoda@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Iwao Sugitani |
Organization
Anaplastic Thyroid Carcinoma Consortium Japan
Division name
Department of Endocrine Surgery, Nippon Medical School
Zip code
Address
1-1-5,Sendagi, Bunkyo-ku, Tokyo 113-8603, Japan
TEL
03-5814-6219
Homepage URL
isugitani@nms.ac.jp
Sponsor or person
Institute
Anaplastic Thyroid Carcinoma Consortium Japan
Institute
Department
Personal name
Funding Source
Organization
Thyroid Oncology Doctors Japan
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
| 2012 | Year | 07 | Month | 31 | 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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 04 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2015 | Year | 03 | 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
| 2012 | Year | 07 | Month | 30 | Day |
Last modified on
| 2014 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010053
