ART Protocol V1.0_20Jun2014

• Research type

  Research Study

• Full title

  Anal squamous cell carcinoma: Investigation of functional imaging during chemoRadioTherapy (ART)

• IRAS ID

  130204

• Contact name

  Rebecca Muirhead

• Contact email

  rebecca.muirhead@oncology.ox.ac.uk

• Sponsor organisation

  University of Oxford Clinical Trials & Research Governance

• Clinicaltrials.gov Identifier

  NCT02145416

• Duration of Study in the UK

  2 years, 7 months, 31 days

• Research summary

  Anal cancer is often curable with radiotherapy combined with chemotherapy. In larger cancers that have may spread to lymph nodes, current radiotherapy dose cannot always kill the most aggressive cells. The cancer often returns needing surgery leaving patients with a lifelong stoma bag, or it spreads becoming incurable.
  • There is suggestion that most aggressive areas of tumour need a bigger dose of radiotherapy. These areas may be identifiable using special scans
  • The study aims are to see whether the aggressive areas can be seen early using different imaging methods, during standard treatment. If we identify the resistant areas then in future we could increase radiotherapy dose to those areas.
  • We hope that in the future this technique could be used to cure a higher number of cases and avoid more stoma bags whilst not causing complicated long term side effects.
  We hope to recruit 16 eligible patients who will be aged 18+, with confirmed invasive primary squamous anal carcinoma, otherwise fit and scheduled to receive radical chemoradiotherapy.
  The study will be conducted at the Churchill Hospital in Oxford. Patients should be on study for a maximum of 5 months.
  The study should not require any extra visits to hospital in addition to the standard routine chemoradiotherapy treatment. As part of the routine radiotherapy work-up, patients have a PET/CT scan to help with planning the treatment. In the study this scan will take slightly longer with additional investigational pCT (perfusion computed tomography) which may offer more information than the normal scan. We will also perform a new MRI scan with extra specialized pictures that cannot be taken using standard MRI. Chemoradiotherapy will then start as planned and when the patient visits for the 10th-12th day of radiotherapy, we will perform another PET/CT, pCT and MRI. These are all investigational, research images.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  14/SC/1130

• Date of REC Opinion

  31 Jul 2014

• REC opinion

  Favourable Opinion