|This is a randomised, multi-centre, phase III trial (two arm study) for patients with MRI defined locally advance rectal cancer. The study aims to determine whether the addition of a second drug (irinotecan) to the standard treatment of oral chemotherapy using capecitabine and radiotherapy improves outcome resulting in fewer cancer recurrences (regrowth) after the operation and if patients live longer.
Randomisation will be 1:1 and will be performed centrally at the UCL CTC and this must be performed prior to commencement of any trial treatment. Randomisation will be based on pre-defined stratification factors and patients will be allocated on one of 2 arms:
– Capecitabine 900mg/m2 orally bd 5 days/week (Mon-Fri) for 5 weeks
– Pelvic radiotherapy 45Gy in 25 fractions
– Irinotecan 60mg/m2 weekly iv(weeks 1,2,3,4)
– Capecitabine 650mg/m2 orally bd 5 days/week (Mon-Fri) for 5 weeks
– Pelvic radiotherapy 45Gy in 25 fractions
Participant sites will be requested to complete a self-assessment monitoring report periodically, at a frequency detailed in the monitoring plan (which has not been submitted yet). Sites will also be requested to submit specific trial documentation to check for consistency and completeness. Any inconsistencies or non-compliance suspicions could result in on-site monitoring visits.
|FOCUS4 is a molecularly stratified, multi-arm, multi-stage design, multi-site randomised trials programme for patients with colorectal cancer (CRC). During the initial registration period (master protocol), all patients are treated with 16 weeks of standard 1st line chemotherapy. During this time they will be registered and consented to send their tumour block sample for biomarker panel assessment.
The results of this assessment will be used to classify the patient into one of the possible molecular cohorts and they will be offered entry into one of the specific trials. There are four molecular cohorts (A, B, C and D) and a fifth trial (N) which will run concurrently for patients whose biomarker results are unclassifiable or for any patients who are unable or unwilling to travel (their site may not be able to offer the trial specifically appropriate for their molecular cohort).
Sites have been classified into three levels. For safety reasons, agents for some of the cohorts(A, B or C)will only be available at level three sites. RSCH has been classed as a level 3 site. This phase 1 work will be carried out in the Clinical Research Centre, University of Surrey.
NB: Initially, only trials D and N will open as the Investigational Medicinal Products for the other cohorts have not yet been agreed upon. These are the trials which will include the phase 1 work.
The study has a website: www.focus4trial.org
Cancers that occur at the junction between the oesophagus (gullet) and the stomach are called gastro oesophageal junction (GOJ) adenocarcinomas. They are 6 times more common than they were 30 years ago and have a very poor outcome (only 1 in 5 patients will survive five years). We have previously developed a new way of determining how advanced a patient’s OJ adenocarcinoma is (this is called staging) using both the physical features determined by the radiology tests and the molecular features of the cancer. This system works significantly better than the existing way we stage these cancers. However this new system was developed using patients who had already had their surgery. The current study now wants to test it on patients at the beginning of their treatment (termed prospectively).
The patients’ management will not differ from current practice but as well as looking at the features used for staging at the moment they will also record the new system in parallel. They will also test samples of the cancer, which are already routinely taken, for the molecular changes thought to predict survival. After this patients will undergo the standard treatment at.
It will then be possible to determine both how practical the new system is and how good it is at predicting survival. If it can be proved that the revised staging system, using both the physical features of the tumour and the olecular changes, can accurately predict outcome this will allow us to give far better information to patients about their chance of a cure but also it will also
allow treatments to be targeted at those who will benefit the most. This study will not affect the care a patient receives in any way. They will undergo the same staging (CT scan, Endoscopic ultrasound, PET scan) as they would do if not in this study. The only difference is the research team will be recording the staging of their tumour using the new system as well as the existing system. All decisions about treatment will be based on the current system.
This research is about measuring the impact of cancer and its treatment on patients and their informal caregivers (e.g. spouse, partner, family member, close friend). Having cancer can affect many aspects of life such as finances, work status and patients’ own caring roles with family or friends, which are important to understand but are not well captured by existing measures.
In studies 1-3 of PROACT we developed and evaluated two questionnaires measuring impact on caregiving and other responsibilities and lifestyle disruption for patients and caregivers. We developed the questionnaires through qualitative interview studies and through collaboration with advisors with lived experience of cancer or caring for someone with cancer. We then conducted some research to determine the reliability and validity of the new measures.
These comparisons are important to ensure that when health care professionals and researchers use our questionnaires, they can be confident that they are measuring wellbeing and impact with a reliable measure. Both
questionnaires performed well in this initial evaluation. In this fourth study we wish to repeat the evaluation with a new group of patients and caregivers. We will expand our inclusion criteria to include different types and stages of cancer. We will use the same methodology as study 3 and invite participants to complete the new PROACT measures three times over two months, along with other quality of life questionnaires at two of these time points. This enables us to see how our new measures perform over time; whether they are reliable if completed twice close together and whether they are able to detect change in wellbeing if completed two months apart in participants whose situations are changing. This next stage in validation is essential to ensure that the questionnaires are suitable for use in future research and practice across different types of cancer.