ArChiMEDEs-Op: Accelerated Hypofractionation, Chemotherapy, Intensity Modulation and Evaluation of Dose Escalation in Oropharyngeal Cancer

 
 Chief Investigator:
  Dr Paul Sanghera
 Sponsor:  University of Birmingham
 NHS Foundation Trust
 Funder:  QE Charities
Disease Site:   Head and Neck
 Trial Type:   Radiotherapy Trial
 Status:   Follow-up
 UKCRN Study ID (if applicable):  
 ISRCTN Referance Number:  44435485
 Open to New Sites?  No
 Recruitment Start Date:  20-Dec-2012
 Recruitment End Date:  22-Jan-2014
 CRCTU Trial Management Team:  Late Phase Trial Management Team- B
 Trial Email Address:  ArChIMEDEs@trials.bham.ac.uk

ArChiMEDEs-Op is a small feasibility study looking at an increased dose of intensity modulated radiotherapy to treat oropharyngeal cancer that is not linked to the human papilloma virus (HPV). HPV negative and/or smoking associated oropharyngeal cancer is associated with a poor prognosis. Treatment of oropharyngeal cancer is usually a combination of chemotherapy and radiotherapy. However this standard treatment doesn’t work so well in cancers that are HPV negative. ArChiMEDEs-Op was designed to investigate the tolerability of a dose intensified schedule in poor prognosis oropharyngeal cancer by delivering a 5 week course of radiotherapy at an increased dose with standard dose chemotherapy to treat oropharyngeal cancer.

ArChiMEDEs-Op closed to recruitment January 2014 having recruited 15 patients at the University Hospitals Birmingham NHS Foundation Trust. Patients taking part in the study have completed their treatment and are now been followed up for 5 years to monitor long-term safety. Preliminary analysis of the primary outcome measures showed that dose intensified radiotherapy schedule with standard dose chemotherapy is tolerable in patients with poor prognosis oropharyngeal cancer. Efficacy against other schedules will be investigated within the randomised controlled phase III trial called CompARE. The preliminary results have been presented at numerous meeting and will soon be published in a scientific journal. 

Please note that the trials team cannot give individual’s clinical advice. Patients and their families should contact their treating physician to discuss trials for which they may be eligible.

Trial Summary

Trial Protocol

Please Note:
Clinical trial protocols are complex technical documents which should only be used for the treatment of subjects taking part in the trial. Patients who are interested in taking part in the trial are advised to talk to their health care professional.

Investigators please ensure you have R&D approval for this specific version of the protocol before using as a reference.

Summary of Trial Results

A list of published abstracts is below:

Harrop V, Meade S, Gaunt P, Babrah J, Wagstaff L, Robinson M, Cashmore J, Mehanna H, Hartley A, Sanghera P. Chemoradiotherapy for poor/intermediate oropharyngeal carcinoma: First results of the ArChIMEDEs-Op study. 5th International Conference on Innovative Approaches in Head and Neck Oncology, 2015. Radiotherapy &Oncology Journal of the European Society for Radiotherapy and Oncology Volume 114 Supplement 1 (2015). Poster Presentation, PO-088

Harrop V, Meade S, Gaunt P, Babrah J, Wagstaff L, Robinson M, Cashmore J, Mehanna H, Hartley A, Sanghera P. Chemoradiotherapy for poor prognosis oropharyngeal carcinoma: 2 year results of the prospective ArCHIMEDEs pilot study. British Association of Head and Neck Oncology (BAHNO) Annual Conference 2016. Poster Presentation

Other Websites

CancerHelp (Cancer Research)