Nedaplatin +Gemcitabine chemotherapy for previously treated thymic cancer

JRCT ID: jRCTs031180359

Registered date:18/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: thymic carcinoma
• Date of first enrollment: 17/01/2017
• Target sample size: 25
• Study type: Interventional
• Intervention(s): Chemotherapy using

Outcome(s)

• Primary Outcome: Response rate
• Secondary Outcome: Overall survival, progression-free survival, adverse events

Key inclusion & exclusion criteria

• Age minimum: 20 years old
• Age maximum: 74 years old
• Gender: Both

Include criteria

1)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 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.

Related Information

• Primary Sponsor: Koizumi Tomonobu
• Secondary ID(s): UMIN000004230