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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN C000000350
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Japanese Association for Research on the Thymus
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000401

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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