Accelerated hypofractionation, Chemotherapy, Intensity Modulation and Evaluation of Dose Escalation in Oropharyngeal cancer
| ISRCTN | ISRCTN44435485 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44435485 |
| Protocol serial number | HN2001 |
| Sponsor | University Hospitals Birmingham NHS Foundation Trust (UK) |
| Funder | Queen Elizabeth Hospital Birmingham Charities (UK) |
- 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
Plain English summary of protocol
Contact information
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 |
|---|---|
| paul.sanghera@uhb.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single arm single centre non-randomised feasibility study |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Cisplatin |
| Primary outcome measure(s) |
Full dose radiotherapy received as planned and the absence of consequential damage defined by the absence of Grade 3 mucositis at 3 months |
| Key secondary outcome measure(s) |
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 |
| Completion date | 02/12/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
B15 2TH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| 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.