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

UMIN ID: UMIN000002168

Registered date:18/07/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: head and neck cancer
• Date of first enrollment: 2009/07/01
• Target sample size: 35
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): S-1 is administered orally at 60 mg/m2 for 14 consecutive days followed by a 7 days rest. A total radiation dose of 70 Gy is planned with conventional fractionation (1.8-2.0Gy/day). Cycles are repeated every 3 weeks until 3 courses. At a radiation dose of 40 Gy, tumor evaluation is carried out intermediary by inspection or image. If patient is in partial response or complete response, concurrent chemoradiation is continued until 70 Gy. 8 weeks after the end of treatment, tumor evaluation is carried out by imaging and biopsy. If remaining cancer cell is detected, patient have a operation.

Outcome(s)

• Primary Outcome: local control rate
• Secondary Outcome: response rate, treatment completion rate, local control time, progression free time, overall survival, safety

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Yokohama City University Graduate School of Medicine
• Source(s) of Monetary Support: Yokohama City University Graduate School of Medicine