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

JRCT ID: jRCTs031190028

Registered date:24/05/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Head and Neck squamous cell carcinoma
• Date of first enrollment: 01/06/2019
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Chemoradiotherapy with weekly carboplatin for head and neck carcinoma

Outcome(s)

• Primary Outcome: Completion rate of chemoradiotherapy

Secondary Outcome

Response rate
Incidense of adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 90age old
• Gender: Both

Include criteria

1)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 criteria

1)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

• Primary Sponsor: Ueki Yushi