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

ISRCTN	ISRCTN00608410
DOI	https://doi.org/10.1186/ISRCTN00608410
Secondary identifying numbers	Ver 1.1

Submission date: 03/03/2008
Registration date: 20/03/2008
Last edited: 13/04/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Prof Johan Wennerberg
Scientific

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

Phone	+46 (0)46 17 28 10
Email	johan.wennerberg@med.lu.se

Study information

Study design	Open label randomised controlled multicentre study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet (Swedish only)
Scientific title	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
Study 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(s)	Ethics approval received from the Regional Ethical Review Board in Umea, Sweden on the 8th January 2008 (ref: 07-178M).
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	Mixed
Primary outcome measure	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 study start date	18/02/2008
Overall study end date	28/02/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	260
Total final enrolment	250
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 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

Study participating centre

Dept of ORL/Head & Neck Surgery

Lund
SE-22185
Sweden

Sponsor information

Umea University Hospital (Sweden)
Hospital/treatment centre

c/o Prof Björn Zackrisson
Department of Oncology
Umea
SE-90185
Sweden

Phone	+46 (0)90 785 00 00
Email	bjorn.zackrisson@onkologi.umu.se
Website	http://www.umu.se/umu/index_eng.html
"ROR"	https://ror.org/012k96e85

Funders

Funder type

Research organisation

The Swedish Cancer Society (Sweden)

No information available

Results and Publications

Intention to publish date	31/12/2019
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration. 2019 results were to be presented at the International Conference on Head and Neck Oncology (ICHNO) in https://user-swndwmf.cld.bz/7th-ICHNO-Abstract-book abstract OC-005
IPD sharing plan	Not provided at time of registration.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/01/2022	13/04/2022	Yes	No

Editorial Notes

13/04/2022: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
28/02/2019: The following changes have been made to the trial record:
1. Conference proceedings added to publication and dissemination plan.
2. An intention to publish date has been added.
3. The overall trial end date has been changed from 01/02/2012 to 28/02/2016.