Condition category
Cancer
Date applied
03/03/2008
Date assigned
20/03/2008
Last edited
20/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Johan Wennerberg

ORCID ID

Contact details

Dept of ORL/Head & Neck Surgery
University Hospital Lund
Lund
SE-22185
Sweden
+46 (0)46 17 28 10
johan.wennerberg@med.lu.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Ver 1.1

Study information

Scientific title

Acronym

ARTSCAN II

Study hypothesis

To compare the efficiency of preoperative accelerated radiotherapy with postoperative radiotherapy, including chemotherapy for high-risk tumours, with respect to local control, disease free survival, overall survival and morbidity.

Ethics approval

Ethics approval received from the Regional Ethical Review Board in Umea, Sweden on the 8th January 2008 (ref: 07-178M).

Study design

Open label randomised controlled multicentre study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet (Swedish only)

Condition

Resectable squamous cell carcinoma of the oral cavity

Intervention

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 days/week during four and a half weeks. The total dose is 68 Gy given in 34 fractions. Radical surgery should be performed in four to six weeks after completion of radiotherapy.
2. Radical surgery is performed up-front. Radiotherapy is started four to six weeks later with conventional fractionation, 2 Gy/fraction, five fractions/week for six weeks to a total dose of 60 Gy. High-risk patients (R1, R2 and/or lymph node metastasis with extracapsular extension) receive three additional fractions to a total dose of 66 Gy and concomitant chemotherapy with cis-platinum 50 mg/week, if there are no contra-indications.

The total duration of follow-up for all treatment arms is five years from start of treatment for each patient in both arms. Twelve months after inclusion of the last patient in the study main analysis will be done.

Joint contact details:
Professor Bjorn Zackrisson
Department of Oncology
Umea University Hospital
Umea SE-90185
Sweden
Email: bjorn.zackrisson@onkologi.umu.se

Intervention type

Drug

Phase

Not Specified

Drug names

Cis-platinum

Primary outcome measures

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 outcome measures

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

Overall trial start date

18/02/2008

Overall trial end date

01/02/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

260

Participant 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

Recruitment start date

18/02/2008

Recruitment end date

01/02/2012

Locations

Countries of recruitment

Sweden

Trial participating centre

Dept of ORL/Head & Neck Surgery
Lund
SE-22185
Sweden

Sponsor information

Organisation

Umea University Hospital (Sweden)

Sponsor details

c/o Prof Björn Zackrisson
Department of Oncology
Umea
SE-90185
Sweden
+46 (0)90 785 00 00
bjorn.zackrisson@onkologi.umu.se

Sponsor type

Hospital/treatment centre

Website

http://www.umu.se/umu/index_eng.html

Funders

Funder type

Research organisation

Funder name

The Swedish Cancer Society (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes