The EN.10/TAPER study is open to recruitment in eight Australian sites and one site in New Zealand. This trial explores ways to treat early-stage endometrial cancers with a focus on minimising side effects and costs. The goal of this trial is to change and inform practice, leading to less toxicity for patients and better utilisation of health care resources internationally.
The trial is led by ANZGOG in ANZ in collaboration with international sponsor, the Canadian Cancer Trials Group (CCTG).
EN.10/TAPER is led by Principal Investigators Professor Alison Brand AM (Australian Study Chair), and Kathy Han and Jessica McAlpine (CCTG Co-Chairs).
A total of 10 sites are planned for Australia and 2-3 in New Zealand. Some will collaborate to enroll and provide deescalated treatment, while others will operate as standalone sites. Internationally, 31 sites are already open – 13 in Canada, five in The Netherlands, three in the USA and one in Italy.
The target patient sample size is set at 120 in ANZ, and internationally, 107 out of 325 patients have been enrolled to date.
EN.10/TAPER Principal Investigator
“Endometrial cancer is the most common of all gynaecological cancers and its incidence is rising rapidly. New research has identified four different molecular subtypes of endometrial cancer. We are now able to identify, through routine tumour testing, those subgroups which have exceptionally good outcomes. We can then safely withhold (i.e., de-escalate) additional treatment, thus avoiding side effects, inconvenience, and cost of treatment, without compromising survival. The EN.10 trial is an international trial which will help us achieve our goal to tailor treatment based on the molecular profile of endometrial cancers, thereby avoiding unnecessary and toxic therapies.”
Prof Alison Brand AM
Gynaecological Oncologist
Why is EN.10/TAPER needed?
Global rises in the incidence rates of endometrial cancer is a concern. In Australia alone, case numbers have doubled over the last 20 years, whilst in New Zealand numbers have nearly trebled. Despite the average age of diagnosis around 60 years, there is a concerning uprise in cases among women under 50 years old.
The primary objective of this study is to estimate the rate of pelvic recurrence at 3 years in patients who are treated with de-escalated adjuvant treatment directed by tumour molecular status.
What is EN.10/TAPER investigating?
The primary objective of this study is to estimate the rate of pelvic recurrence at 3 years in patients who are treated with de-escalated adjuvant treatment directed by tumour molecular status.
Adjuvant radiotherapy is not always associated with a survival benefit but does have associated toxicities. This single-arm phase II trial will evaluate a molecularly driven, de-escalation adjuvant treatment strategy for POLE-mutated and p53wt/no-specific molecular profile (NSMP) early-stage endometrial cancers.
The hypothesis is that de-escalation of adjuvant therapy in patients with POLE-mutated or p53 wildtype (p53wt)/NSMP endometrial cancer is associated with a low risk of pelvic recurrence, less treatment-related symptom burden and cost savings.
Eligibility criteria
The trial may be suitable for women with POLE-mutated or p53wt/NSMP (p53 wildtype/no specific molecular profile) early-stage endometrial cancer.
It is advisable that patients discuss their concerns and the best course of action regarding their participation in clinical trials with their oncologist.
Where will EN.10/TAPER be available?
| State | Site Name | Principal Investigator |
| NSW | Westmead Hospital | Prof Alison Brand |
| NSW | Liverpool Hospital | Dr Viet Do |
| VIC | Frankston Hospital | A/Prof Yoland Antill |
| VIC | Peter MacCallum Parkville/
The Royal Women’s Hospital |
A/Prof Pearly Khaw (Peter Mac PI)
A/Prof Orla McNally (RWH PI) |
| VIC | Peter MacCallum Moorabbin/
Monash Medical Centre |
Dr Ming-Yin Lin (Peter Mac Co-PI)
Dr Shih-Ern Yao (Monash PI) |
| QLD | Mater Hospital | Dr Nimithri Cabraal |
| QLD | Royal Brisbane and Women’s Hospital | Dr Andy Garrett |
| ACT | Canberra Hospital | Dr Andrew Lee |
| New Zealand | Christchurch Hospital | Dr Briony Simcock |
Why Patient referrals to EN.10/TAPER
We encourage referrals to this study via medical professionals. Please contact the Clinical Trial Project Manager at EN.10@anzgog.org.au for more information.
For more information on the participation criteria please visit our trials page.
