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UMIN-CTR Clinical Trial |
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Name: | 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 |
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 |
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Condition | ||||||
Condition | Thymoma (excluding thymic carcinoma) | |||||
Classification by specialty |
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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 |
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Interventions/Control_1 | Carboplatin AUC5-6, day 1
Paclitaxel 180-210mg/m2 day 1 or 60-70mg/m2 weekly x3 |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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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 |
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Last modified on |
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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 |