|MAC.20 (A011401) - Randomized Phase III Trial Evaluating the Role of Weight Loss In Adjuvant Treatment of Overweight and Obese Women with Early Breast Cancer
The primary objective of this study is to compare the effect of a supervised weight loss intervention plus health education materials versus health education materials alone upon invasive disease free survival (iDFS) in overweight (BMI 27-29.9 kg/m2) and obese (BMI ≥ 30kg/m2) women diagnosed with HER-2 negative, stage II and III breast cancer.
Secondary objectives are to:
Centres interested in participating in this trial should contact Maaike Hum, Study Coordinator, at firstname.lastname@example.org.
- Determine the relationship between changes in weight and iDFS, and to explore interaction between the level of clinical benefit from weight loss and the intervention;
- Evaluate the effect of a supervised weight loss intervention upon:
- Overall survival
- Distant disease free survival
- Body composition (as measured by waist and hip circumference)
- Insulin Resistance Syndrome associated conditions ? diabetes, hospitalization for CV disease;
- Determine the impact of a supervised weight loss intervention on IDFS within subgroups of women with hormone receptor positive breast cancer and hormone receptor negative breast cancer; and,
- Determine the impact of a supervised weight loss intervention on IDFS within subgroups of premenopausal women and post-menopausal women.
PR.19 - A Randomized Phase II Trial Evaluating High Dose Rate (HDR) Brachytherapy and Low Dose Rate (LDR) Brachytherapy as Monotherapy in Localized Prostate Cancer
The primary objective of this study is to evaluate the efficacy of HDR and LDR brachytherapy on prostate cancer control as defined by 48-month PSA values.
Secondary objectives are to evaluate both treatment strategies with respect to:
Centres interested in participating in this trial should contact Kate Whelan, Study Coordinator, at email@example.com.
- Disease-free survival;
- Acute and long-term toxicity and safety, including lower urinary tract symptoms;
- Quality of Life (QOL) of the patient and his partner; and,
- Resource utilization and economic indices of treatment administration.