Improving the Treatment for Women With Early Stage Cancer of the Uterus
Last updated on April 2022Recruitment
- Recruitment Status
- Unknown status
- Estimated Enrollment
- 111
Inclusion Criteria
- No hypersensitivity or contraindications for Mirena
- Histologically confirmed complex endometrial hyperplasia with atypia or grade 1 endometrioid endometrial adenocarcinoma on a curette or endometrial biopsy
- Myometrial invasion on MRI of not more than 50%, for women with histologically confirmed Endometrial Cancer only (for women who are unable to fit into an MRI machine inclusion into trial is at investigators discretion)
- ...
- No hypersensitivity or contraindications for Mirena
- Histologically confirmed complex endometrial hyperplasia with atypia or grade 1 endometrioid endometrial adenocarcinoma on a curette or endometrial biopsy
- Myometrial invasion on MRI of not more than 50%, for women with histologically confirmed Endometrial Cancer only (for women who are unable to fit into an MRI machine inclusion into trial is at investigators discretion)
- Serum CA125 ≤ 30 U/mL
- Females with a BMI > 30 kg/m2 wishing to retain fertility or females who are at high risk of surgical complications due to co-morbidities or obesity
- Negative serum or urine pregnancy test in pre-menopausal women and women < 2 years after the onset of menopause
- Ability to comply with endometrial biopsies at specified intervals
- No lymph vascular invasion on curetting or pipelle, if able to be assessed on sample
- CT or MRI scan of pelvis, abdomen and chest (or chest X-Ray) suggesting the absence of extrauterine disease
- Over 18 years of age at time of randomisation
- Creatinine < 150µmol/L (1.7 mg/dL) to be randomised into Mirena + Metformin arm (can still be eligible to be randomised to Mirena only or Mirena + Weight Loss, see section 5.4 Other Eligibility Criteria Considerations)
Exclusion Criteria
- Unable or unwilling to complete questionnaires
- Genital actinomycosis
- Patients with a history of pelvic or abdominal radiotherapy
- ...
- Unable or unwilling to complete questionnaires
- Genital actinomycosis
- Patients with a history of pelvic or abdominal radiotherapy
- Conditions associated with increased susceptibility to infections with microorganisms (e.g., AIDS, leukaemia, IV drug abuse) according to the patients Medical History
- Congenital or acquired uterine anomaly which distorts the uterine cavity
- Unable to provide informed consent
- Breastfeeding mothers
- Previous use of Mirena within the last 5 years from randomisation/enrolment
- Unwilling to have additional endometrial biopsies or curettes and unable to attend three monthly clinical assessments
- Current other cancer, except low grade malignancies that do not require any systemic treatment or treatment to the pelvis
- Contraindications to both Metformin and weight loss
- Pregnant or planning to become pregnant during trial period
- ECOG performance status > 3
- Evidence of extrauterine spread on medical imaging
- Histological (cell) type other than endometrioid adenocarcinoma (sarcomas or high risk endometrial e.g. papillary serous, clear cell)
- Grade 1 endometrioid adenocarcinoma of the endometrium with myometrial invasion deeper than 50% on MRI or any patients with grade 2 or grade 3 endometrioid adenocarcinoma
- Acute pelvic inflammatory disease
- Mirena inserted greater than 12 weeks before randomisation/enrolment
- Has had prior treatment or undergoing current treatment for EAC or EHA
Summary
- Conditions
- Complex Endometrial Hyperplasia With Atypia
- Grade 1 Endometrial Endometrioid Adenocarcinoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only females
Inclusion Criteria
- No hypersensitivity or contraindications for Mirena
- Histologically confirmed complex endometrial hyperplasia with atypia or grade 1 endometrioid endometrial adenocarcinoma on a curette or endometrial biopsy
- Myometrial invasion on MRI of not more than 50%, for women with histologically confirmed Endometrial Cancer only (for women who are unable to fit into an MRI machine inclusion into trial is at investigators discretion)
- ...
- No hypersensitivity or contraindications for Mirena
- Histologically confirmed complex endometrial hyperplasia with atypia or grade 1 endometrioid endometrial adenocarcinoma on a curette or endometrial biopsy
- Myometrial invasion on MRI of not more than 50%, for women with histologically confirmed Endometrial Cancer only (for women who are unable to fit into an MRI machine inclusion into trial is at investigators discretion)
- Serum CA125 ≤ 30 U/mL
- Females with a BMI > 30 kg/m2 wishing to retain fertility or females who are at high risk of surgical complications due to co-morbidities or obesity
- Negative serum or urine pregnancy test in pre-menopausal women and women < 2 years after the onset of menopause
- Ability to comply with endometrial biopsies at specified intervals
- No lymph vascular invasion on curetting or pipelle, if able to be assessed on sample
- CT or MRI scan of pelvis, abdomen and chest (or chest X-Ray) suggesting the absence of extrauterine disease
- Over 18 years of age at time of randomisation
- Creatinine < 150µmol/L (1.7 mg/dL) to be randomised into Mirena + Metformin arm (can still be eligible to be randomised to Mirena only or Mirena + Weight Loss, see section 5.4 Other Eligibility Criteria Considerations)
Exclusion Criteria
- Unable or unwilling to complete questionnaires
- Genital actinomycosis
- Patients with a history of pelvic or abdominal radiotherapy
- ...
- Unable or unwilling to complete questionnaires
- Genital actinomycosis
- Patients with a history of pelvic or abdominal radiotherapy
- Conditions associated with increased susceptibility to infections with microorganisms (e.g., AIDS, leukaemia, IV drug abuse) according to the patients Medical History
- Congenital or acquired uterine anomaly which distorts the uterine cavity
- Unable to provide informed consent
- Breastfeeding mothers
- Previous use of Mirena within the last 5 years from randomisation/enrolment
- Unwilling to have additional endometrial biopsies or curettes and unable to attend three monthly clinical assessments
- Current other cancer, except low grade malignancies that do not require any systemic treatment or treatment to the pelvis
- Contraindications to both Metformin and weight loss
- Pregnant or planning to become pregnant during trial period
- ECOG performance status > 3
- Evidence of extrauterine spread on medical imaging
- Histological (cell) type other than endometrioid adenocarcinoma (sarcomas or high risk endometrial e.g. papillary serous, clear cell)
- Grade 1 endometrioid adenocarcinoma of the endometrium with myometrial invasion deeper than 50% on MRI or any patients with grade 2 or grade 3 endometrioid adenocarcinoma
- Acute pelvic inflammatory disease
- Mirena inserted greater than 12 weeks before randomisation/enrolment
- Has had prior treatment or undergoing current treatment for EAC or EHA
Tracking Information
- NCT #
- NCT01686126
- Collaborators
- The University of Queensland
- Queensland University of Technology
- Investigators
- Study Chair: Andreas Obermair Queensland Centre for Gynaecological Cancer