Head and Neck Cancer Clinical Trial
— TPSHNSCCOfficial title:
Multicenter Phase II Study of Weekly Docetaxel, Cisplatin, and S-1 (TPS) Induction Chemotherapy in Locally Advanced Squamous Cell Cancer of the Head and Neck
Verified date | July 2012 |
Source | Chonnam National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Institutional Review Board |
Study type | Interventional |
The purpose of this study was to evaluate the tolerability and efficacy of a combination of weekly docetaxel, cisplatin, and S-1 (weekly TPS) as induction chemotherapy in patients with locally advanced head and neck squamous cell carcinoma (HNSCC).
Status | Completed |
Enrollment | 35 |
Est. completion date | March 2012 |
Est. primary completion date | October 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - locally advanced stage III or IV squamous cell carcinoma of the larynx, oropharynx, or hypopharynx - =18 years old - absolute neutrophil count =1,500/µL, platelets =100,000/µL - serum bilirubin <2.0 mg/dL - creatinine <1.5 mg/dL - serum transaminase levels less than twice the upper limit of normal Exclusion Criteria: - received previous chemotherapy - another malignancy - current or history of distant metastasis - history of clinically significant cardiac disease within 6 months - active serious infection - nasopharyngeal carcinoma - psychiatric illness that would preclude obtaining informed consent |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Chonnam National University Hwasun Hospital | Gwangju | Jeollanamdo |
Lead Sponsor | Collaborator |
---|---|
Chonnam National University Hospital | Chonbuk National University, Chungbuk National University, Chungnam National University |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response rate | After completion of CCRT, response rate was assessed. Patients underwent examination by an otolaryngologist, CT or MRI imaging of the primary tumor and neck. A biopsy of the primary site was recommended if possible. Tumor response was assessed according to the RECIST. For all patients with complete response (CR) on physical examination and CT or MRI scan, PET scan was performed for confirmation at 1 month after CT or MRI confirmation. | Response rate was evaluated 1 months after completion of CCRT | No |
Secondary | Safety | Number of participants with adverse events as a measure of safety according to NCI-CTC version 3.0 was checked every 3 weeks up to 18 weeks. | From initiation of induction chemotherapy up to 18 weeks | Yes |
Secondary | Progression free survival | Progression free survival means that the time from date of initiation of treatment until the date of first documented progression. Patients who completed treatment were followed by physician examination and CT or MRI scanning every 3 months for 1 year and then these checkup was done every 6 months for another one year. | From initiation of treatment up to 2 years | No |
Secondary | Overall survival | Overall survival means that the time from initiation of treatment until the date of death from any cause up to 2 years | From initiatin of treatment up to 2 years | No |
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