Condition category
Cancer
Date applied
09/02/2012
Date assigned
25/05/2012
Last edited
01/05/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Not provided at time of registration

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 measures

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

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

03/09/2012

Recruitment end date

02/12/2019

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

University of Birmingham
Research and Development Office
HSRC Building
Birmingham
B15 2TH
United Kingdom
+44 (0)121 371 4185
Chris.counsell@uhb.nhs.uk

Sponsor type

University/education

Website

http://www.uhb.nhs.uk/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes