Contact information
Type
Scientific
Primary contact
Dr Paul Sanghera
ORCID ID
Contact details
University Hospitals Birmingham NHS Foundation Trust
Queen Elizabeth Hospital
Queen Elizabeth Medical Cancer Centre
Birmingham
B15 2TH
United Kingdom
+44 (0)121 472 1311
paul.sanghera@uhb.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HN2001
Study information
Scientific title
Accelerated hypofractionation, Chemotherapy, Intensity Modulation and Evaluation of Dose Escalation in Oropharyngeal cancer: a non randomised study
Acronym
ArChIMEDEs-Op
Study hypothesis
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
West Midlands Research Ethics Committee, South Birmingham, ref. 12/WM/0112.
Study design
Single arm single centre non-randomised feasibility study
Primary study design
Interventional
Secondary study design
Non 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
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
03/09/2012
Overall trial end date
02/12/2019
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
15
Participant 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
Recruitment start date
02/11/2012
Recruitment end date
22/01/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Hospitals Birmingham NHS Foundation Trust
Birmingham
B15 2TH
United Kingdom
Sponsor information
Organisation
University Hospitals Birmingham NHS Foundation Trust (UK)
Sponsor details
Mendelsohn Way
Birmingham
B15 2TH
United Kingdom
+44 (0)121 371 4185
Chris.counsell@uhb.nhs.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Queen Elizabeth Hospital Birmingham Charities (UK)
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
Basic results (scientific)
Publication list
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29478732