UMIN-CTR Clinical Trial

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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