Recurrent or disseminated squamous cell carcinoma of the head and neck Cancer Squamous cell carcinoma of the head and neck
Conditions
Interventions
The treatment plan was as follows:
Day 1: Paclitaxel 175 mg/m2 iv over 3 h
Days 1 to 14: Capecitabine 825 mg/m2 per dose orally bid (twice daily) for 2 weeks, with 200 ml water taken <30 min after a
Sponsors
Department of Oncology, Herlev Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed recurrent or disseminated squamous cell carcinoma of the head and neck region, not suitable for curative radiotherapy or salvage surgery 2. Measurable disease in minimum 2 dimensions 3. Aged 18-75 years 4. World Health Organization (WHO) performance status <=2 5. No previous chemotherapy for 1 month 6. No other severe life-shortening disease or other malignant disease 7. Adequate bone marrow, liver, and renal function
Exclusion criteria
Exclusion criteria: 1. Non-measurable disease 2. Pregnant or breastfeeding women 3. Chemotherapy within the last month 4. Brain metastases 5. Other malignant disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Response rate as defined by WHO Handbook for Reporting Results of Cancer Treatment. Patients were only eligible if they had at least one lesion measurable in two dimensions using Ultasound, MRI scan or CT-scan. Lesions were measured at baseline and after every 3 cycles ( every 9th week). 2. Toxicity was measured by blood samples and patient interview after every treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall survival was measured from the day chemotherapy started until death. 2. Compliance was measured as number of treatment cycles given at 100% dose and number of treatments given without toxicity-related delay. | — |
Countries
Denmark
Outcome results
None listed