Prospective observational study of combined modality therapy based on algorithmic chemoradioselection strategy in head and neck squamous cell carcinoma

Prospective observational study of combined modality therapy based on algorithmic chemoradioselection strategy in head and neck squamous cell carcinoma - Prospective observational study of combined modality therapy based on algorithmic chemoradioselection strategy in head and neck squamous cell carcinoma

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000049781

Enrollment

200

Registered

2022-12-15

Start date

2016-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

head and neck squamous cell carcinoma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Histologically or Cytological proven squamous cell carcinoma of the head and neck Primary lesion located at oropharynx, hypopharynx, or larynx ECOG performance status 0 to2 No history of irradiation to head and neck Adequate organ function including; WBC>=3,500/mm3 platlet>=100,000 Creatinin clearance>=30 (Cockcroft-Gault formula) Written informed consent Women of child-bearing potential and men who are able to father a child agree with using adequate contraception

Exclusion criteria

Exclusion criteria: Patients who reject chemoradiotherapy or bioradiotherapy as initial therapeutic intervention T4a cases with extensive distruction of laryngeal framework and in-operable T4b cases Distant metastasis cases Sever heart disease or heart failure Myocardial infarction or angina attack within 6 month Cases with Synchronous multiple primary cancer other than esophageal cancer which can be treated by Endoscopic Submucosal Dissection or endoscopic mucosal resection Other significant disease that in the investigator's opinion would exclude the subject from the trial.

Design outcomes

Primary

Measure	Time frame
overall survival	—

Secondary

Measure	Time frame
laryngeal preservation rate swallowing function	—

Countries

Japan

Contacts

Public ContactSatoshi Toh

National Hospital Organization Kyushu Cancer Center Department of Head and Neck Surgery

sttoshny@gmail.com0925413231

Outcome results