UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000350 |
|---|---|
| Receipt number | R000000401 |
| Scientific Title | Phase II study of Chemotherapy for Advanced or Recurrent Thymoma |
| Date of disclosure of the study information | 2006/04/01 |
| Last modified on | 2006/11/02 12:31:02 |
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Basic information
Public title
Phase II study of Chemotherapy for Advanced or Recurrent Thymoma
Acronym
Chemotherapy for Advanced Thymoma
Scientific Title
Phase II study of Chemotherapy for Advanced or Recurrent Thymoma
Scientific Title:Acronym
Chemotherapy for Advanced Thymoma
Region
| Japan |
Condition
Condition
Thymoma (excluding thymic carcinoma)
Classification by specialty
| Medicine in general | Hematology and clinical oncology | Neurology |
| Surgery in general | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the effectiveness of Carboplatinplus Paclitaxel for advanced or recurrent thymoma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Overall response
Adverse effects
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
Carboplatin AUC5-6, day 1
Paclitaxel 180-210mg/m2 day 1 or 60-70mg/m2 weekly x3
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Thymoma, Masaoka Clinical Stage III or IV or recurrent thymoma.
Performance Status 0-2.
Measurable tumor (on CT, MRI or Chest X-ray).
Pathological diagnosis of thymoma (excluding thymic cancer)(preferably with WHO classification).
White blood cell count 4000/mm3 or more.
Hemoblobin 9.0mg/dl or more.
Serum AST, ALT not exceeding 100IU/L.
Serum creatinin less than 1.2mg/dl.
Total bilirubin 1.5mg/dl or less.
Patient signs the written informed conscent.
Key exclusion criteria
Patients with malignancies other than thymoma (those with CR can be included).
Patients who has been treated with steroid pulse therapy within one month of the registration.
Patients on oral steroid at a dose of more than 26mg every other day or 13mg everyday.
Pregnant women.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Fujii |
Organization
Nagoya City University Medical School
Division name
Second Department of Surgery
Zip code
Address
1 Kawasumi, Mizuhoku, Nagoya 467-8601 Japan
TEL
052-853-8231
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Fujii |
Organization
Nagoya City University Medical School
Division name
Second Department of Surgery
Zip code
Address
1 Kawasumi, Mizuhoku, Nagoya 467-8601
TEL
052-853-8231
Homepage URL
Sponsor or person
Institute
Japanese Association for Research on the Thymus
Institute
Department
Personal name
Funding Source
Organization
Japanese Association for Research on the Thymus
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
| 2006 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
http://plaza.umin.ac.jp/thymus/index.html
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
Terminated
Date of protocol fixation
| 2006 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 08 | Month | 01 | Day |
Other
Other related information
The report of the autopsy of the case reported below revealed a stage IVa thymoma, giant cell myositis of skeletal muscle throught the body including right and left ventricles. Whether the chemotherapy triggered the myositis is unknow. A very similar fatal case of thymoma after the same chemotherapy has been reported Am J Clin Oncol 29:213. The office of this clinical trial decided to discontinue this trial to avoid further risk.
The clinical course of the patient: 58 male patient with stage IVa thymoma received the chemotherapy on 2006.7.11 and 8.2. He received GCSF due to decreased white blood cell count 1000/mm3. He had fever and soar throat on 8.19. He was admitted due to high fever (39C) on 8.23. His serum CK was found to be elevated to 7271 on 8.28; serum myoglobin was 4000ng/ml and urin myoglobin 90000ng/ml on 8.30. He was found dead on 8.31.
(2006.11.2)
A case of suspected rhabdomyolysis with high CK and repiratory failure has reported (2006.8.31). Protocol has been changed to include measurement of serum CK, termination of the protocol when CK is increased, and others (see above URL for detail). The treatment of the patient can be resumed when the protocol change has been approved and the patient is informed of this incidence. The causal relationships between the study drugs and the rhabdomyolysis is unknown. (2006.9.19)
Management information
Registered date
| 2006 | Year | 03 | Month | 07 | Day |
Last modified on
| 2006 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000401
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