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The PRIME Breast Cancer TrialPost-operative Radiotherapy In Minimum-risk Elderly |
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PRIME is a randomised clinical trial, assessing the role of post-operative radiotherapy in older patients following breast conserving surgery and adjuvant endocrine therapy on survival, local recurrence and quality of life.
PRIME was developed to address the research question: "Are we overtreating older breast cancer patients with good prognostic factors?". Much research went into examining the background into this question, (which is examined in more detail here). This led us to formulate the question "Is there a group of women for whom breast radiotherapy is unnecessary?".
PRIME I |
PRIME II |
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| The focus of this phase of the trial was Quality of Life, with a target of 240 patients. Patients were randomly allocated to radiotherapy or no radiotherapy. They were interviewed four times over a period of 15 months using standardised quality of life scales, and followed up in the clinic to record their physical reactions to the treatment. This phase is now closed to recruitment, and we hope to be able to report the early results shortly. | This second phase builds on PRIME I but focuses on local control of cancer and survival. The patient's clinical status is recorded annually at the normal clinic visits for at least 5 years. The target for PRIME II is 1000 patients, although a substantial number of these will come from PRIME I. This phase is currently open, and full details on how to participate can be found on the PRIME II page. |
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