NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs031180359

Registered date:18/03/2019

Nedaplatin +Gemcitabine chemotherapy for previously treated thymic cancer

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedthymic carcinoma
Date of first enrollment17/01/2017
Target sample size25
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Chemotherapy using

Outcome(s)

Primary OutcomeResponse rate
Secondary OutcomeOverall survival, progression-free survival, adverse events

Key inclusion & exclusion criteria

Age minimum20 years old
Age maximum74 years old
GenderBoth
Include criteria1)Histologically 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.
Exclude criteria1)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.

Related Information

Contact

Public contact
Name Tomonobu Koizumi
Address 3-1-1 Asahi Matsumoto,Nagano 390-8621, Japan Nagano Japan 390-8621
Telephone +81-263-37-2554
E-mail tomonobu@shinshu-u.ac.jp
Affiliation Shinshu University Faculty of Medicine
Scientific contact
Name Tomonobu Koizumi
Address 3-1-1 Asahi Matsumoto,Nagano 390-8621, Japan Nagano Japan 390-8621
Telephone +81-263-37-2554
E-mail tomonobu@shinshu-u.ac.jp
Affiliation Shinshu University Faculty of Medicine