Phase II trial of S-1 with concurrent radiotherapy in T2N0M0 laryngeal, mesopharynx, hypopharynx cancer

Phase 2

• Conditions: head and neck cancer

• Registration Number: JPRN-UMIN000002168
• Lead Sponsor: Yokohama City University Graduate School of Medicine

Brief Summary

From August 2009 to October 2012, 37 patients were evaluated for the study. The overall response rate was 100%. The 3-year local control rate was 89.0% (95% confidence interval (CI), 78.9-99.2%), and the 3-year overall survival rate was 97.2% (95% CI, 91.8-100%). Mucositis and dermatitis in the radiation field were the most common acute adverse events observed. The rates of Grade 3 mucositis and dermatitis were 27% and 35%, respectively. No patients experienced Grade 4 acute adverse events. The treatment completion rate was 89.2% As a conclusion, CCRT with S-1 was safe and effective in improving local control for stage II SCC of the pharynx or larynx.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-07-18
• Study Completion: 2014-06-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

1)with active double cancer 2)with severe complications (congested heart failure, coronary insufficiency, myocardial infarction, angina pectoris or abnormal cardiac rhythm which need to treat, history of cerebrovascular accident, hemorrhagic gastrointestinal ulceration, uncontrolled diabetes, renal failure, active hepatitis, liver cirrhosis) 3)with develop fever and suspected infection 4)with motor palsy, peripheral neuropathy or edema (exclude the disorder which derives from primary disease) 5)with pleural effusion which need to treat or pericardial effusions 6)pregnant or nursing women or women who like be pregnant and men with partner willing to get pregnant 7)with interstitial pneumonitis which is revealed from chest X ray and chest CT 8)with history of mental disorder or treating it at the moment 9)with history of severe allergy 10)with severe allergy to S-1 11)patients receiving 5-FU based chemotherapy 12)patients receiving Flucytosine 13)doctor's decision not to be registered to this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
local control rate

Secondary Outcome Measures

Name	Time	Method
response rate, treatment completion rate, local control time, progression free time, overall survival, safety