Clinical Trial: Can DW MRI Predict Outcome During Radiotherapy for Head and Neck Cancer?

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Study of Diffusion Weighted MRI as a Predictive Biomarker of Response During Radiotherapy for High and Intermediate Risk Squamous Cell Cancer of the Oropharynx (MeRInO Stu

Brief Summary:

Around 50% of patients with locally advanced H&N cancer fail to achieve loco-regional control. Currently it cannot be predicted, during treatment, who will fall into this group of non-responders.

This study is designed to assess the value of DW MRI as a predictive biomarker of response to radiotherapy in intermediate and high risk OPSCC.


Detailed Summary:

Around 1000 patients with new cancers of the head and neck (H&N) are registered in Scotland annually. Approximately 60% of these are managed in the west of Scotland. Unfortunately a large proportion, around 60%, of H&N cancers present with locally advanced but non-metastatic disease. These are associated with poor outcomes with 3 year survival around 50%. Despite intensive radical therapy associated with significant acute toxicity, there is a high recurrence rate (up to 50%) and unlike many other cancers, the vast majority of these recurrences, around 80%, occur locally and many patients go on to die from their local disease without developing distant metastases. Locally recurrent tumours cause significant morbidity and palliation is difficult. There is a therefore a clear need to further improve local disease control, both to increase cure rates and to improve quality of life.

This study is designed to assess the value of DW MRI as a predictive biomarker in intermediate and high risk OPSCC. DW MRI and changes in ADC have been shown to correlate with response to treatment in prospective and retrospective studies in SCC H&N. These studies have included all H&N sub-sites with no differentiation between biological sub-types. This study may therefore validate the use of DW MRI as a predictive biomarker specifically in the intermediate and high risk groups of OPSCC. If change in ADC during RT is found to be predictive of eventual clinical outcome and a discriminatory threshold rise in ADC identified, this information could be used to inform treatment intensification in patients responding poorly to RT. This would form the basis of subsequent clinical trials.

The hypothesis of this study is that quantitative DW MRI - i.e. change in ADC during RT - is predictive of locoregional control in intermediate and high ris
Sponsor: NHS Greater Glasgow and Clyde

Current Primary Outcome:

  • change in composite ADC [ Time Frame: 3 weeks ]
    Apparent Diffusion Coefficient measured at each MRI for each target lesion and the % change in each target lesion will be recorded at MRI2, in comparison with MRI1
  • Relapse status [ Time Frame: 18 months ]
    Relapse status (control or failure), for each target lesion, will be recorded at the 18 month time point and compared with baseline. Control is defined as absence of any new mass, serial reduction in size or unchanged size of residual mass. Failure is defined as biopsy proven recurrence, new mass or serial increase in size of residual mass.


Original Primary Outcome:

  • change in composite ADC [ Time Frame: 3 weeks ]
    Apparent Diffusion Coefficient measured at each MRI for each target lesion and the % change in each target lesion will be recorded at MRI2, in comparision with MRI1
  • Relapse status [ Time Frame: 18 months ]
    Relapse status (control or failure), for each target lesion, will be recorded at the 18 month time point and compared with baseline. Control is defined as absence of any new mass, serial reduction in size or unchanged size of residual mass. Failure is defined as biopsy proven recurrence, new mass or serial increase in size of residual mass.


Current Secondary Outcome: Time to Relapse [ Time Frame: Up to 22 Months ]

If relapse occurs (failure), the time to relapse, from baseline, will be recorded. Failure is defined as biopsy proven recurrence, new mass or serial increase in size of residual mass.


Original Secondary Outcome: Time to Relapse [ Time Frame: Up to 22 Months ]

If replase occurs (failure), the time to replase, from baseline, will be recorded. Failure is defined as biopsy proven recurrence, new mass or serial increase in size of residual mass.


Information By: NHS Greater Glasgow and Clyde

Dates:
Date Received: July 6, 2015
Date Started: May 2016
Date Completion: June 2020
Last Updated: November 1, 2016
Last Verified: November 2016