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

Phase 2

• Conditions: Head and Neck squamous cell carcinoma; Head and neck carcinoma, squamous cell carcinoma, ineligible for cisplatin treatment; D000077195

• Registration Number: JPRN-jRCTs031190028
• Lead Sponsor: eki Yushi

Brief Summary

Concurrent chemoradiotherapy with low-dose weekly carboplatin showed favorable feasibility, efficacy and acceptable safety for cisplatin ineligible patients with head and neck squamous cell carcinoma. These results suggested that concurrent chemoradiotherapy with weekly carboplatin can be a promising treatment option for head and neck squamous cell carcinoma patients who are unsuitable for standard therapy.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-24
• Study Completion: 2022-06-21
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 30

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Completion rate of chemoradiotherapy

Secondary Outcome Measures

Name	Time	Method
Response rate<br>Incidense of adverse events