Accelerated RadioTherapy of Squamous Cell carcinoma of the head And Neck - study II: preoperative accelerated versus postoperative conventional radiotherapy in patients with resectable cancer of the oral cavity

Not Applicable

Completed

• Conditions: Resectable squamous cell carcinoma of the oral cavity; Cancer; Squamous cell carcinoma

• Registration Number: ISRCTN00608410
• Lead Sponsor: mea University Hospital (Sweden)

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/34793864/ (added 13/04/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-03-20
• Study Completion: 2016-02-28
• Last Update Posted: 25 April 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 250

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ocal 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 Outcome Measures

Name	Time	Method
<br> 1. Survival:<br> 1.1. Overall, measured with continuous monitoring<br> 1.2. Cause specific, measured every three-four months during the first two years and every six months thereafter until five years have passed<br> 2. Quality of life, measured before treatment start, after six months, one, two and five years<br> 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<br>