Randomized phase II syudy of weekly docetaxel versus S-1 and concurrent radiothrapy for stage III and IV laryngeal, oropharyngeal, and hypopharyngeal cancer in elderly patients or patients with complications

UMIN ID: UMIN000001144

Registered date:01/05/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: laryngeal, oropharyngeal, and hypopharyngeal cancer
• Date of first enrollment: 2008/04/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Docetaxel administration group: Administration of 5 courses (5 weeks) concurrent chemotherapy in which one course consists of docetaxel 12mg/m2 weekly. A total radiation dose of 70 Gy is planned with conventional fractionation (1.8-2Gy/day). After a total dose of 40 Gy, all patients were clinically evaluated by endoscopy, and by computed tomography scan or magnetic resonance image. Patients with a 50% or greater decrease in the product of 2 perpendicular diameters of primary and neck tumors (responders) continued chemotherapy and completed radiotherapy. For non-responders with resectable tumor, definitive surgery was recommended. 4-6 weeks after the end of treatment, tumor evaluation will be carried out by biopsy, aspiration cytology, and image. If remaining cancer cells is detected in the patient, the patient have a operation.
S-1 administration group: Administration of 2 courses (6 weeks) concurrent chemotherapy in which one course consists of S-1 65mg/m2 for 2 weeks administration followed by 1 week rest. A total radiation dose of 70 Gy is planned with conventional fractionation (1.8-2Gy/day). After a total dose of 40 Gy, all patients were clinically evaluated by endoscopy, and by computed tomography scan or magnetic resonance image. Patients with a 50% or greater decrease in the product of 2 perpendicular diameters of primary and neck tumors (responders) continued chemotherapy and completed radiotherapy. For non-responders with resectable tumor, definitive surgery was recommended. 4-6 weeks after the end of treatment, tumor evaluation will be carried out by biopsy, aspiration cytology, and image. If remaining cancer cells is detected in the patient, the patient have a operation.

Outcome(s)

• Primary Outcome: Response rate
• Secondary Outcome: locoregional relapse free survival, survival with primary organ preservation, overall survival, treatment completion rate, incidence and severity of adverse events, economic analysis

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 85years-old
• Gender: Male and Female
• Exclude criteria: 1)with sever complications (for example ; malignant hypertension, congested heart failure, coronary insufficiency, myocardial infarction, angina pectoris, or abnormal cardiac rhythm which need to treat within 6 months, cerebrovascular accident within 6 months, cirrhosis, hemorrhagic gastrointestinal ulceration, diabetes that is loss of control, bleeding tendency) 2)with deverop fever and suspected infection 3)with motor palsy, peripheral neuropathy or edema (exclude the disorder which derives from primary disease) 4)with pleural effusion which need to treat or pericardial effusions 5)with active double cancer 6)pregnant or nursing women or women who like be pregnant 7)with interstitial pneumonitis which is revealed from chest X ray or chest CT 8)with a history of mental disorder or treated it at the moment 9)with sever allergy to docetaxel or S-1, or with a history of sever allergy 10)doctor's decision not to be registered to this study

Related Information

• Primary Sponsor: study group of chemoradiotherapy of the head and neck cancer
• Source(s) of Monetary Support: study group of chemoradiotherapy of the head and neck cancer