A Phase II Randomised Clinical Trial of Mirena® ± Metformin ± Weight Loss in Patients with Early Stage Cancer of the Endometrium Study Chair: Andreas Obermair.

Slides:



Advertisements
Similar presentations
Advanced Stage Prostate Cancer Management Michael E. Karellas Assistant Professor of Urologic Oncology May 15, 2010.
Advertisements

A trial for women with –‘Triple negative’ breast cancer (TNBC) –Localised to breast +/- lymph nodes –Recommended standard treatment involves NEPTUNE Taxane.
Rare Tumour Working Group. Active Trials GOG 187 Phase 2 paclitaxel as 2 nd line therapy for ovarian stromal tumours-almost complete GOG239-Phase 2 AZD6244(MEK.
Departments - Surgery - Gerontology and Geriatrics Department of SurgeryDepartment of Gerontology & Geriatrics Prof. dr. C.J.H. van de VeldeProf. dr. R.G.J.
Turning Questions into Trials: Innovation in Surgical Oncology Jennifer E. Rosen MD FACS Assistant Professor of Surgery and Molecular Medicine Boston University.
First HAYAT Annual Patients Forum – 21 st March 2010 – SAS, Kuwait First HAYAT Annual Patients Forum 21 st March 2010 Al Hashimi II Ballroom – SAS Hotel.
Results of a Phase II Trial of Brentuximab Vedotin as First Line Salvage Therapy in Relapsed/Refractory HL Prior to AHCT Chen RW et al. Proc ASH 2014;Abstract.
Breast Cancer 101 Barbara Lee Bass, MD, FACS Professor of Surgery
InFUSE ™ Bone Graft / LT-CAGE ™ Lumbar Tapered Fusion Device IDE Clinical Results G Hallett H. Mathews, M.D. Richmond, Virginia.
Neoadjuvant Chemotherapy in Ovarian Cancer Key issues in trial design.
Ovarian cysts in Primary Care. When to refer? Physiological/pathological Benign/malignant Surgical approach? Open or keyhole? Do I need to do anything?
Unity Point Palliative Care Services
Breast conservation in Locally advanced breast cancer Department of Endocrine Surgery College of Medicine Amrita Institute of Medical Sciences Kochi, Kerala.
ACRIN Abdominal Committee ACRIN Gynecologic Committee Fall Meeting 2010.
Consent for Research Study A study for patients with a diagnosis of liver cancer who are on the waiting list for a liver transplant Comparison of advanced.
Fight obesity with effective and guaranteed tools t Haitham Al-Khayat, MD Consultant general and bariatric surgeon New Dar Al-Shifa hospital.
Diseases of the Pancreas November 19, 2007 NCDD Meeting Chair: Jane Holt Vice Chair: P. Jay Pasricha, MD.
Value of Endothelin Receptor Inhibition with Tezosentan in Acute Heart Failure Studies VERITAS Trial Presented at The American College of Cardiology Scientific.
SARC015: Phase II study of R1507 in wild-type GIST Margaret von Mehren, Fox Chase Cancer Center Katie Janeway, Dana Farber Cancer Institute.
Management of Rib Fractures. Clinical Anatomy 12 pairs of ribs Attach posteriorly to vertebrae Rib 8-12 are “false ribs” Ribs 1-3 are relatively well.
Endometrial Carcinoma
Surrogate End point for Prostate Cancer- Specific Mortality After RP or EBRT A D’Amico J Nat Ca Inst 95,
Are there benefits from chemotherapy to early endometrial cancer
Study design P.Olliaro Nov04. Study designs: observational vs. experimental studies What happened?  Case-control study What’s happening?  Cross-sectional.
Bariatric Surgery and Metabolism Goal: to review 4 important and clinically relevant papers from 2010 on Bariatric Surgery and Metabolism 10/10/20151.
INT Translational research in head and neck cancer: preoperative chemotherapy in oral cavity cancer based on disease molecular profiling. Paolo Bossi MSO.
ACRIN 6685 Overview ACRIN 6685 A Multi-center Trial of FDG-PET/CT Staging of Head and Neck Cancer and its Impact on the N0 Neck Surgical Treatment in Head.
Targeting HER2 and Focusing on Patients With Gastric Cancer Jose Maria Vieitez, MD, PhD Assistant Professor of Oncology Department of Medical Oncology.
Monthly Journal article review: Vimmi Kang PGY 2
When ? Indications Contraindications ?. When ? Indications Contraindications ?
Home More Information about I-SPY 2 Participating Cancer Centers Peer Support for I-SPY 2 Participants More Information About Breast Cancer I-SPY 2 Breast.
JOURNAL PRESENTATION By: Nur Izzatul Ashikin Harun Moderator: Dr Abdul Karim Othman.
Osaka University Department of Cardiovascular Surgery Osaka University Department of Cardiovascular Surgery The efficacy of debranching TEVAR for arch.
Alternating Courses of CHOP and DHAP Plus Rituximab (R) Followed by a High-Dose Cytarabine Regimen and ASCT is Superior to Six Courses of CHOP Plus R Followed.
Lapatinib versus Trastuzumab in Combination with Neoadjuvant Anthracycline-Taxane-Based Chemotherapy: Primary Efficacy Endpoint Analysis of the GEPARQUINTO.
Malignant & Pre-malignant Diseases of the Endometrium Jose B Moran MD Assistant Professor III Section of Gynecologic Oncology Department of Obstetrics.
Copenhagen University Hospital Rigshospitalet, Denmark
ACRIN 6682 Phase II Trial OF 64 Cu-ATSM PET/CT in Cervical Cancer Principal Investigator: Farrokh Dehdashti, MD 10/4/08.
Melanoma: assessment and management NICE guideline NG14 Full guideline July 2015.
ACP at Allina System Direction Primary care focus to align with a strong primary care vision (ACO & Allina Health) Revision of ACP as a baseline.
BTS/ICS Guidelines for the ventilatory management of acute hypercapnic respiratory failure in adults British Thoracic Society Intensive Care Society.
R3 정수웅. Introduction Community-acquired pneumonia − Leading infectious cause of death in developed countries − The mortality in patients with treatment.
Adjuvant Chemotherapy for Non–Small-Cell Lung Cancer in the Elderly: A Population-Based Study in Ontario, Canada JOURNAL OF CLINICAL ONCOLOGY, VOLUME 30.
Dr Julius Cairn. Introduction - update COPD Exacerbations Pulmonary rehabilitation Lung cancer - NSCLC Treatments for patients with limited lung function.
Elderly Women Ovarian Cancer Multicenter, randomized trial of carboplatin +/- paclitaxel in vulnerable elderly patients with stage III-IV advanced ovarian.
PHASE II TRIAL OF HYPOFRACTIONATED BREAST IRRADIATION WITH VMAT-SIB TECHNIQUE: TOXICITY AND EARLY CLINICAL ASSESSMENT IN 270 PATIENTS F. De Rose¹, F. Alongi¹,
ADJUVANT CAPECITABINE AND OXALIPLATIN FOR GASTRIC CANCER AFTER D2 GASTRECTOMY (CLASSIC): A PHASE 3 OPEN-LABEL,RANDOMISED CONTROLLED TRIAL Yung-Jue Bang*,
ACOSOG Sarcoma Committee Chair: Peter W.T. Pisters, MD Vice Chairs: Edward Cheng, MD (Orthopedic Oncology) Robert Maki, MD, PhD (Medical Oncology) Brian.
ELIGIBILITY CRITERIA- Summarised
A cura di Filippo de Marinis
Korde N et al. Proc ASH 2012;Abstract 732.
Copenhagen University Hospital Rigshospitalet, Denmark
ENDOMETRIAL HYPERPLASIA
A Low Carbohydrate Nutritional Program Improves Weight, Insulin, and Estrogenic Parameters in Obese Patients with Estrogen Receptor Positive Endometrial.
OPTIMIZING TREATMENT FOR ADVANCED OVARIAN CANCER:
The postmenopausal bleeding (PMB)
Uterine cancer Uterine mesenchymal neoplasms
Tertiary cytoreductive surgery in recurrent epithelial ovarian cancer:
Does One Size Fit All in Obesity Management?
Dr Jessica Jenkins Consultant Oncologist
Precision Management of RA and Comorbidities
Untch M et al. Proc SABCS 2010;Abstract P
Valencia, España SESION CONTROVERSIAS ¿Es necesario modificar el desarrollo clínico de los nuevos fármacos? COMENTARIOS Y DISCUSION Andres.
Hallett H. Mathews, M.D. Richmond, Virginia
19,628 operations in NSW for LSS between 2003 and 2013
Management of Endometrial Hyperplasia D Hind Showman
MITO 26 PHASE II TRIAL ON TRABECTEDIN IN THE TREATMENT OF ADVANCED UTERINE AND OVARIAN CARCINOSARCOMA (CS)
Background Bariatric interventions offer a more efficacious and durable weight loss than non-surgical approaches Surgical weight loss procedures are limited.
Perspectives in Palliative Care
Trials Update May 2019.
Presentation transcript:

A Phase II Randomised Clinical Trial of Mirena® ± Metformin ± Weight Loss in Patients with Early Stage Cancer of the Endometrium Study Chair: Andreas Obermair Trial Manager: Fiona Menzies Trial Coordinator: Kerry Millgate

Background Endometrial cancer common in AUS  Becoming increasingly common in young women still desiring fertility  Becoming common in elderly patients suffering from significant medical co-morbidities (increased surgical risks)  Problem area: Super obese patients  Surgical complications high  Conversion to open surgery high  Hospital stay + Costs significant

Adverse events are common Morbidly obese woman EAC FIGO g1, no myoinvasion Respiratory failure secondary to pneumonia Unplanned ICU admission on day 5; Requires ventilation, imaging, i.v. ABs

Treatment alternative is availabale Progestins offered on case-to-case basis (Mirena ± oral progestins)

Study Objectives  Primary: To determine the efficacy of Mirena IUD ± Metformin ± Weight Loss to achieve a pathological complete response (pCR) in endometrial cancer at 6 months from study treatment start.  Secondary: Endometrial cancer biomarkers will be assessed at different time points to enhance our understanding of the molecular processes and to predict a treatment response.

Study Endpoints  Primary: Pathological Complete Response  Secondary: To predict the response to treatment through clinical, blood and tissue molecular biomarkers and to increase our molecular understanding of the biological pathogenesis of “early” EAC.

Schema of patient flow through study Mirena ± Metformin ± Weight Loss

feMME Trial - Eligibility Target: 95 ± 75 patients with complex endometrial hyperplasia with atypia or grade 1 EAC Eligibility:  Complex Endometrial Hyperplasia with atypia OR  Grade 1 EAC – avoid enrolling patients with advanced disease who need expedited surgery  Patients at high surgical risks or wish to retain fertility  BMI > 30 kg/m2  CT scan: absence of extrauterine disease  MRI: Myometrial invasion <50%  Serum CA125 ≤30 U/mL

Contact Andreas Obermair: Acknowledgements: QUT (M Janda), ANZGOG (RAC, Val Gebski) Endorsed by ANZGOG and ASGO National Ethics Application (covers NSW, VIC) QCGC will facilitate HREC applications in other states