Resectable squamous cell carcinoma of the oral cavity Cancer Squamous cell carcinoma
Conditions
Interventions
Patients will be randomised to:
1. Accelerated pre-operative radiotherapy with a concomitant boost technique. The treatment is given in two daily fractions (interval greater than seven hours), five da
Sponsors
Umea University Hospital (Sweden)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Over the age of 18 years, either sex 2. Resectable (as classified before surgery with radical intent), histological proven, previously untreated, squamous cell carcinoma of all grades and stages in the oral cavity without distant metastases. All T3-T4 and/or N2-3 tumours of the oral cavity can be included. Additionally T1-T2 and any N tumours of the oral cavity can be included provided the tumour is invading at clinical/radiological examination. 3. The tumour has to be judged as accessible for primary radical surgery and the patient must be expected to withstand combined surgery and radiotherapy 4. The patient must be able to understand the information about the treatment and give a written informed consent to participate in the trial
Exclusion criteria
Exclusion criteria: 1. Previous anti-tumour treatment within three months before treatment 2. Evidence of distant metastases beyond the regional nodes in the neck 3. Co-existing disease prejudicing survival will exclude the patient (expected survival greater that six months) 4. Previous malignant disease in the head and neck region will exclude the patient with exception for basal cell carcinoma or curatively treated squamous cell carcinoma of the skin with follow-up time of at least three years 5. Adequate follow-up study must be possible; this will exclude a patient who is uncooperative
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local and regional tumour control. Measurements will be done every three to four months during the first two years and every six months thereafter until five years have passed. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Survival: 1.1. Overall, measured with continuous monitoring 1.2. Cause specific, measured every three-four months during the first two years and every six months thereafter until five years have passed 2. Quality of life, measured before treatment start, after six months, one, two and five years 3. Morbidity related to tumour/treatment, measured every three-four months during the first two years and every six months thereafter until five years have passed | — |
Countries
Sweden
Outcome results
None listed