Grant: Operating Grant

Cervix cancer is the second leading cause of cancer death in women. Most recent statistics estimate that almost 500,000 women globally will be diagnosed with cervical cancer each year and more than 270,000 annually will die from it. Due to effective screening strategies in developed countries, the incidence of cervical cancer has decreased but the proportion of young women presenting with low-risk early-stage disease has increased. The traditional treatment for these women is radical hysterectomy. This is a very effective procedure and has a high cure rate, but is associated with potentially severe and long-lasting side-effects. These include impairment of bowel, bladder and/or sexual function and infertility, which may lead to poorer quality of life. Some gynecologists who specialize in cancer surgery believe a less extensive surgical procedure (simple hysterectomy) will provide the same cure rate as radical surgery and will reduce the chances of the adverse effects described above. However, no studies have directly compared the effectiveness and the short and long-term side-effects of simple and radical hysterectomy in women with low-risk early stage disease. There is a need to determine which procedure is optimal and to standardize treatments. The proposed trial, CX.5, will be led by an established network of Canadian cancer investigators known as the NCIC Clinical Trials Group and will include participation of other international groups. The objective of CX.5 is to determine whether simple hysterectomy is as good as radical hysterectomy in preventing cancer from recurring and better in preventing the side-effects associated with surgery. Important secondary outcomes include evaluation of quality of life, measures of sexual health, and cost-effectiveness and cost-utility analyses. The trial will include 700 women from across the world, including 135 from Canada and will take 8 years to complete.