Endometrial adenocarcinoma
Conditions
Brief summary
The proportion (%) of patients with a pCR in each group 12 months (52 weeks ±14 days) post randomisation. pCR will be defined as the absence of any EAC or endometrial hyperplasia on endometrial biopsy using a H&E slide assessed by an independent pathologist after 12 months (Visit 14, 52 weeks ±14 days) of treatment.
Detailed description
The mean percentage fasting weight loss at 12 months (Visit 14, 52 weeks ±14 days) post randomization., The change in Ki-67 PI 12 months (Visit 14, 52 weeks ±14 days) post randomization., Quality of life assessment at baseline (day -30 to 0), 3 (Visit 4, Week 12, 6 (Visit 7, Week 24), and 12 months (Visit 14, 52 weeks ±14 days)., Safety - The proportion of patients who develop progressive disease during the trial at 6 and 12 months. Progression is defined in section 3.4., Progression to surgery - The proportion of patients who progress to surgical management of endometrial cancer ie. hysterectomy following weight loss
Interventions
DRUGMirena 52 mg Intrauterine delivery system
Sponsors
University College Dublin
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion (%) of patients with a pCR in each group 12 months (52 weeks ±14 days) post randomisation. pCR will be defined as the absence of any EAC or endometrial hyperplasia on endometrial biopsy using a H&E slide assessed by an independent pathologist after 12 months (Visit 14, 52 weeks ±14 days) of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| The mean percentage fasting weight loss at 12 months (Visit 14, 52 weeks ±14 days) post randomization., The change in Ki-67 PI 12 months (Visit 14, 52 weeks ±14 days) post randomization., Quality of life assessment at baseline (day -30 to 0), 3 (Visit 4, Week 12, 6 (Visit 7, Week 24), and 12 months (Visit 14, 52 weeks ±14 days)., Safety - The proportion of patients who develop progressive disease during the trial at 6 and 12 months. Progression is defined in section 3.4., Progression to surgery - The proportion of patients who progress to surgical management of endometrial cancer ie. hysterectomy following weight loss | — |
Outcome results
None listed