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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000004230 |
Receipt No. | R000005085 |
Scientific Title | Phase II Study of Nedaplatin and Gemcitabine in Previously Treated Advanced Thymic Carcinoma Patients |
Date of disclosure of the study information | 2010/10/01 |
Last modified on | 2014/04/24 |
Basic information | ||
Public title | Phase II Study of Nedaplatin and Gemcitabine in Previously Treated Advanced Thymic Carcinoma Patients | |
Acronym | Phase II Study of Nedaplatin and Gemcitabine in Previously Treated Advanced Thymic Carcinoma Patients | |
Scientific Title | Phase II Study of Nedaplatin and Gemcitabine in Previously Treated Advanced Thymic Carcinoma Patients | |
Scientific Title:Acronym | Phase II Study of Nedaplatin and Gemcitabine in Previously Treated Advanced Thymic Carcinoma Patients | |
Region |
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Condition | ||
Condition | Thymic carcinoma | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the efficacy and safety of nedaplatin plus gemcitabine in previously treated advanced thymic carcinoma patients. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Response rate |
Key secondary outcomes | Overall survival, progression-free survival, adverse events |
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 | administration of nedaplatin and gemcitabine | |
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 | 1)Historogically or cytologically confirmed thymic carcinoma.
2)Unresectable disease or recurrent disease after surgery. 3)One or more prior chemotherapy or chemoradiotherapy. 4)Measurable by RECIST criteria. 5)ECOG Performance status of 0-2. 6)Sufficient organ functions. 1.WBC >= 4000/mm3 2.neutrophil >= 2000/mm3 3.Hb >= 9.0g/dL 4.Plt >= 100000/mm3 5.T-bil < 1.5mg/dL 6.AST, ALT < 100IU/L 7.Cr < 1.5mg/dL 8.PaO2 >= 60Torr or SpO2 >= 90% 7)Expected to live over 3 months 8)Written informed consent. |
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Key exclusion criteria | 1)Symptomatic brain metastasis
2)Poorly controlled pleural or pericardial effusion. 3)Need for thoracic radiation. 4)History of double cancer within 5 years. 5)Serious complications. 1.Uncontrollable heart disease (heart failure, ischemic heart disease). 2.History of myocardial infarction within 6 months. 3.Interstitial pneumonia or pulmonary fibrosis detectable on chest X ray. 4.Uncontrollable diabetes mellitus. 5.Uncontrollable hypertension. 6.Active infection. 6)History of severe allergy. 7)Previous administration of nedaplatin or gemcitabine. 8)Now pregnant or lactation. 9)Judged to be not suitable by the attending physician. |
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Target sample size | 25 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Shinshu University School of Medicine | ||||||
Division name | First Department of Internal Medicine | ||||||
Zip code | |||||||
Address | 3-1-1 Asahi, Matsumoto, Japan | ||||||
TEL | 0263-37-2631 | ||||||
shintarokanda@gmail.com |
Public contact | |||||||
Name of contact person |
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Organization | Shinshu University School of Medicine | ||||||
Division name | First Department of Internal Medicine | ||||||
Zip code | |||||||
Address | 3-1-1 Asahi, Matsumoto, Japan | ||||||
TEL | 0263-37-2631 | ||||||
Homepage URL | |||||||
shintarokanda@gmail.com |
Sponsor | |
Institute | First Department of Internal Medicine, Shinshu University School of Medicine |
Institute | |
Department |
Funding Source | |
Organization | Shinshu University Hospital |
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 | |
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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 | |
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 | Enrolling by invitation | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
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=R000005085 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |