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A gynecological cancer clinical trial - EN10

Tailoring therapy in post-surgical patients with low risk endometrial cancer
Disease Site
Gynecology Clinical Trials
Trial Code
EN10 | NCT05640999
Trial Status
Open to patient enrollment

What is the purpose of this study?

The purpose of this study is to identify people who may not require treatment after surgery or may require less treatment after surgery because their cancer is at such a low risk of coming back based on the specific tumour features found by the laboratory testing and the extent of tumour spread. Receiving no treatment or less treatment can result in no or fewer side effects (fatigue, hair loss, bowel and bladder irritation).

Why is this study important?

This study is being done to answer the following question: Are there types of early-stage endometrial cancer that require less treatment than the usual approach?

We want to find out if receiving no treatment or less treatment is better or worse than the usual approach for your early-stage endometrial cancer. The usual approach is defined as care most people receive for early-stage endometrial cancer.

Who can participate in this study?

This trial is for people 18 years of age or older who have Stage I to III endometrial carcinoma and have had surgery to remove the uterus, fallopian tubes and ovaries.

What are the risks?
  • If you choose to take part in this study, getting no treatment or less treatment after surgery means there is a risk that the cancer may have a greater chance of coming back. Researchers will monitor this closely. You will find details of all side effects in the consent document.
What can I expect?
  • If you decide to take part in this study, the specific features of your tumour found by the laboratory testing and the extent of tumour spread will be reviewed. Based on the results, your doctor might recommend that you join the trial. The specific therapy that is recommended to you will consist of no additional therapy after surgery or less therapy than you would have received as part of your usual treatment.In this study, you will also be asked to complete a few questionnaires at different times, for us to understand your quality of life.

 

How can I find out more or join the study?

 

Always talk to your doctors and other health care providers if you are considering joining a clinical trial. You can share summaries like this with them and ask if they think joining the trial may be a good option for you.

The EN.10 study is currently enrolling patients at centres in Canada. For a full list of participating centres please visit www.clinicaltrials.gov and search using NCT05640999.

Before you decide to join any clinical trial, you will be asked to review an Informed Consent document. Discussion with your physician and the informed consent document will tell you more about why the research is being done and your role as a participant. Please ask the study doctor if anything is not clear or if you if you have questions.

Joining clinical trials is entirely up to you and you can decide to leave at any time without giving a reason. Your decision to join or leave the trial will not affect your standard medical care.

Use this trial information for your conversation with your health care team

 

Participating centres
  • CIUSSS de l'Estrie - Centre hospitalier universitaire de Sherbrooke - Sherbrooke, QC, J1H 5N4 - Contact: Dr. Mathieu Viau
  • The Jewish General Hospital - Montreal, QC, H3T 1E2 - Contact: Dr. Susie K.S. Lau
  • CHUM-Centre Hospitalier de l'Universite de Montreal - Montreal, QC, H2X 3E4 - Contact: Dr. Maroie Barkati
  • Odette Cancer Centre Sunnybrook Health Sciences Centre - Toronto, ON, M4N 3M5 - Contact: Dr. Helen MacKay
  • University Health Network Princess Margaret Cancer Centre - Toronto, ON, M5G 2M9 - Contact: Dr. Kathy Han
  • Trillium Health Partners - Credit Valley Hospital - Mississauga, ON, L5M 2N1 - Contact: Dr. Katherine Jane Pulman
  • Verspeeten Family Cancer Centre - London, ON, N6A 5W9 - Contact: Dr. Lucas Castro Mendez
  • Tom Baker Cancer Centre - Calgary, AB, T2N 4N2 - Contact: Dr. Tien Phan
  • Cross Cancer Institute - Edmonton, AB, T6G 1Z2 - Contact: Dr. Fleur Huang
  • BCCA - Vancouver - Vancouver, BC, V5Z 4E6 - Contact: Dr. Jessica McAlpine
  • BCCA - Kelowna - Kelowna, BC, V1Y 5L3 - Contact: Dr. Hamid Raziee
  • BCCA - Prince George - Prince George, BC, V2M 7E9 - Contact: Dr. Allison Ye
  • BCCA - Victoria - Victoria, BC, V8R 6V5 - Contact: Dr. Caroline Holloway