NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs031190028

Registered date:24/05/2019

chemoradiotherapy with weekly carboplatin for head and neck carcinoma ineligible for cisplatin

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedHead and Neck squamous cell carcinoma
Date of first enrollment01/06/2019
Target sample size30
Countries of recruitment
Study typeInterventional
Intervention(s)Chemoradiotherapy with weekly carboplatin for head and neck carcinoma

Outcome(s)

Primary OutcomeCompletion rate of chemoradiotherapy
Secondary OutcomeResponse rate Incidense of adverse events

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 90age old
GenderBoth
Include criteria1)Pathologic or cytologic diagnosis of head and neck squamous cell carcinoma treated with radical chemoradiotherapy, ie, whole-neck irradiation including bilateral levels II-IV 2)Measurable or evaluable lesions 3)Over 20 and less than 75 years with moderate renal dysfunction (over 30 and less than 60ml/min of eGFR) 4)Over 75 and less than 90 years old with over 40ml/min of eGFR 5)Performance status(PS) 0-2 6)Adequate organ functions defined as indicated below before registration in 14 days White blood cells >3,000/ mm3 Neutrophilic >1,500/mm3 Blood platelet >100,000/mm3 Total bilirubin less than 2 times as standard AST and ALT less than 2 times as standard 7)Written informed consent
Exclude criteria1)Past history of serious drug hypersensitivity 2)Presence of other cancer 3)Clinically problematic infectious disease 4)Severe complication that might affect treatment (eg. emphysema or interstitial pneumoniae) 5) Nonradical treatment indicated 6) Continuous administration of steroid or immunosuppressant 7) Pregnant or nursing women and those with the possibility of pregnancy 8) Refusal to birth control during participation 9Mental or neurologic disease that might affect participation 10)Participation judged by physician to be inadvisable

Related Information

Contact

Public contact
Name Yushi Ueki
Address Asahimachi-dori 1-754, Chuo-ku, Niigata City, Niigata Niigata Japan 951-8520
Telephone +81-25-227-2306
E-mail ucuekin@gmail.com
Affiliation Niigata University Medical &amp; Dental Hospital
Scientific contact
Name Yushi Ueki
Address Asahimachi-dori 1-754, Chuo-ku, Niigata City, Niigata Niigata Japan 951-8520
Telephone +81-25-223-6161
E-mail ucuekin@gmail.com
Affiliation Niigata University Medical &amp; Dental Hospital