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Example 3.12 Protocol UKW3 (1992): Preoperative chemotherapy in Wilms’ tumour 4. ELIGIBILITY

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All patients with renal tumours should be registered with the UKCCSG by the participating centres.

The following patients are eligible for this study:

 Patients over 6 months and under 16 years at the time of diagnosis. Clinical and radiological evidence of unilateral Wilms’ tumour considered to be operable – see section 7.

 No detectable distant metastases.

 No previous treatment for Wilms’ tumour

Although criteria for eligibility to a trial can always be phrased as ‘Inclusions’, it may be appropriate sometimes to highlight some aspects of (non) eligibility more forcibly as ‘Exclusions’. Thus, in a trial of a new oral contraceptive rather than phrase an eligibility condition as, for example: ‘Women who are neither pregnant nor breastfeeding’; one might state under a distinct heading of Exclusions: ‘Women who are pregnant or breastfeeding’. Then the clinical team can more readily identify those individuals who are, or are not, eligible. Therefore, this section of the protocol is often better presented as a series of (short) bullet points rather than as prose. Further, it is also important to list these in as useful sequence as possible, perhaps one that reflects closely the logistics of the clinical examination process. For example, if there is an age restriction on those patients who can enter the trial, this might be at the top of such a bulleted list as age is easily determined in most circumstances; for a patient outside the permitted range, there would be little point in checking further inclusion or exclusion criteria especially if these involve an invasive examination which is not part of routine clinical practice. Also high on the list might be ascertaining whether or not all the protocol treatment options are suitable for the potential trial recruit. This saves time and inconvenience for both the would‐be trial patient and the protocol team. One example is the weight limit of 140 kg in the PRESSURE (2000) protocol although it is listed as last amongst the specified Exclusion criteria. In this case, its low position within the list may well be entirely justified, since such a bodyweight is rare amongst the types of patients concerned.

Randomised Clinical Trials

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