Accelerated hypofractionation, Chemotherapy, Intensity Modulation and Evaluation of Dose Escalation in Oropharyngeal cancer

ISRCTN	ISRCTN44435485
DOI	https://doi.org/10.1186/ISRCTN44435485
Secondary identifying numbers	HN2001

Submission date: 09/02/2012
Registration date: 25/05/2012
Last edited: 26/02/2020

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 of protocol

http://www.cancerresearchuk.org/cancer-help/trials/a-study-looking-increased-dose-intensity-modulated-radiotherapy-treat-head-neck-cancer-archimedes-op

Contact information

Dr Paul Sanghera
Scientific

University Hospitals Birmingham NHS Foundation Trust
Queen Elizabeth Hospital
Queen Elizabeth Medical Cancer Centre
Birmingham
B15 2TH
United Kingdom

Phone	+44 (0)121 472 1311
Email	paul.sanghera@uhb.nhs.uk

Study information

Study design	Single arm single centre non-randomised feasibility study
Primary study design	Interventional
Secondary study design	Non 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
Scientific title	Accelerated hypofractionation, Chemotherapy, Intensity Modulation and Evaluation of Dose Escalation in Oropharyngeal cancer: a non randomised study
Study acronym	ArChIMEDEs-Op
Study objectives	To determine whether it is safe and feasible to deliver a 5 week schedule of dose escalated intensity modulated chemoradiotherapy for poor prognosis patients with Human Papillomavirus (HPV) negative and P16 negative locally advanced squamous carcinoma of the oropharynx (SCCOP) in the context of a feasibility study.
Ethics approval(s)	West Midlands Research Ethics Committee, South Birmingham, ref. 12/WM/0112.
Health condition(s) or problem(s) studied	Locally advanced squamous carcinoma of the oropharynx
Intervention	Patients entered into the study will receive intensity modulated chemoradiotherapy (IMRT), 64Gy in 25F for 5 weeks. Chemotherapy (cisplatin) will also be given as standard practice once in the 1st week and once in the last week of radiotherapy.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Cisplatin
Primary outcome measure	Full dose radiotherapy received as planned and the absence of consequential damage defined by the absence of Grade 3 mucositis at 3 months
Secondary outcome measures	1. Duration of Grade 3 mucositis: defined as the number of days of Grade 3 mucositis scored using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3 2. Incidence of acute Grade 4 toxicity defined according to the NCI CTCAE version 4 3. Incidence of ≥ Grade 3 late toxicity defined according to RTOG (see appendix 2) and CTCAE version 4 scoring systems 4. Complete response rate at 3 months defined as no clinically visible (including endoscopic evaluation), palpable or measurable disease on imaging OR the absence of residual tumour on directed biopsy/neck dissection. The primary tumour and regional lymph nodes will be considered separately 5. Two year local control defined as no re-appearance of tumour within primary site (including immediately adjoining anatomical sites) or regional lymph nodes after complete response 6. Two year disease free survival defined in whole days, as the time from entry into the study until death from any cause. Patients will be censored at the date last seen alive. All patients will be followed up for at least 5-years 7. Two year overall survival defined in whole days as the time from entry into the study until death from any cause. Patients will be censored at the date last seen alive. All patients will be followed up for at least 5-years 8. Incidence of feeding tube dependency at one year defined by the patient requiring supplementation of nutrition by a feeding tube
Overall study start date	03/09/2012
Completion date	02/12/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	15
Key inclusion criteria	1. Histologically proven, P16 negative SCCOP deemed suitable for radical primary chemoradiotherapy with curative intent requiring bilateral neck irradiation. Neoadjuvant chemotherapy and pre or post chemoradiation neck dissections are permitted 2. Only patients requiring bilateral radiotherapy 3. Age ≥18 and <75 years 4. World Health Organisation (WHO) performance status 0 or 1 5. Adequate bone marrow: absolute neutrophil count > 1,800 cells/mm3, platelets > 100,000 cells/mm3, haemoglobin > 8.0 g/dl 6. Creatinine clearance > 50 ml/minute 7. Informed consent
Key exclusion criteria	1. Prior invasive malignancy (except basal cell carcinoma and cervical intraepithelial neoplasia) within last 3 years 2. Prior radiotherapy to the head and neck region 3. Pregnancy and/or lactation 4. Reproductive capability agreement to use contraceptive 5. Contraindications to cisplatin chemotherapy including active vascular disease (e.g. myocardial within last 6 months, angina and symptomatic peripheral vascular disease) 6. Non curative intent 7. Non squamous cell carcinoma histology 8. Nasophaynx, larynx, hypopharynx, salivary gland or sino-nasal primary site 9. Other physical or psychiatric disorder that may interfere with subject compliance, adequate informed consent, follow up or determine the causality of adverse events 10. Suitable for unilateral radiotherapy
Date of first enrolment	02/11/2012
Date of final enrolment	22/01/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University Hospitals Birmingham NHS Foundation Trust

Birmingham
B15 2TH
United Kingdom

Sponsor information

University Hospitals Birmingham NHS Foundation Trust (UK)
University/education

Mendelsohn Way
Birmingham
B15 2TH
England
United Kingdom

Phone	+44 (0)121 371 4185
Email	Chris.counsell@uhb.nhs.uk
Website	http://www.uhb.nhs.uk/
"ROR"	https://ror.org/014ja3n03

Funders

Funder type

Charity

Queen Elizabeth Hospital Birmingham Charities (UK)

No information available

Results and Publications

Intention to publish date
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
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2018		Yes	No
Plain English results			26/02/2020	No	Yes

Editorial Notes

26/02/2020: Link to basic results added to results (plain English)
07/02/2019: The sponsor details were updated.
06/02/2019: The following changes were made:
1. The recruitment start date was changed from 03/09/2012 to 02/11/2012.
2. The recruitment end date was changed from 02/12/2019 to 22/01/2014.
3. The ethics approval was added.
4. Publication reference added.