Recruiting

Hypo Fractionated Radiotherapy

Sponsor:

McGill University Health Centre/Research Institute of the McGill University Health Centre

Code:

NCT07871838

Conditions

Endometrial Cancer

Endometrial Adenocarcinoma

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hypo fractionated RT

Study Details

Brief summary:

Clinical experience with hypo fractionated radiotherapy to date has shown that it is a safe and effective way to treat many types of cancer. Hypo fractionation means that the patient receives a total of 5 radiation treatments every other day, rather than 25 treatments over 5 weeks.

The goal of this study is to find out how safe this special kind of radiation technique is for women with endometrial cancer, both right after the treatment and later on. We also want to see how well this treatment works in stopping the cancer from coming back and how it affects the patients' overall health and quality of life. The main question it aims to answer is:

How does this particular type of radiotherapy affect the patients in terms of short and long term side effects?

Participants will:

  • Visit the clinic for a total of 15 times in 60 months for check ups
  • Complete a total of 9 questionnaires throughout the 15 visits
  • Have standard-of-care blood tests and imaging to monitor the cancer response to treatment

Conditions

Endometrial Cancer

Endometrial Adenocarcinoma

Study ID

NCT07871838

Start date

Mar 7, 2025

Status verified date

Oct, 2026

Completion date

Aug, 2035

Anticipated

Primary completion date

Aug, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients 18 years of age or older, ECOG 0-2.
  • Newly diagnosed endometrial carcinoma, including endometrioid, serous, clear cell, carcinosarcoma, and dedifferentiated tumours.
  • FIGO 2009 stage I-IIIC1 are eligible. 20.
  • Patients will have had previous total hysterectomy + bilateral salpingo-oophorectomy + sentinel lymph node biopsy or pelvic nodal dissection, will be fully debulked (R0 resection).
  • Have an indication for adjuvant pelvic radiotherapy by the attending radiation oncology physician at tumour board discussion.

Exclusion Criteria:

  • ECOG 3 or higher.
  • Para-aortic nodal disease.
  • Non-standard surgery, evidence of residual disease after surgery.
  • Need of a radiotherapy field exceeding the whole pelvis.
  • Active inflammatory bowel disease.
  • Active scleroderma.
  • Previous cancer in the last 5 years (except non-melanoma skin cancer).
  • Patients with contraindication to CT contrast.
  • Inability to achieve dose constraints.
  • Inability to reproduce simulation positioning during treatment.

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Study Treatment

Hypo fractionated radiotherapy regimen in patients with EC receiving adjuvant WPRT.

Interventions

Hypo fractionated RT

The patients will receive whole pelvic radiotherapy (WPRT) to a total dose of 28.5 Gy in 5 fractions in alternate days (BED 64.6 Gy), delivered by RapidArc. Vaginal brachytherapy boost, 6 Gy in 1 fraction, is allowed in patients with cervical stroma involvement

Primary outcome measure

  • Primary Outcome Measure [ Time Frame: Three years ]

Central Contacts and Locations

Central contacts

Joanne Alfieri, MD

514-934-1934joanne.alfieri@ssss.gouv.qc.ca

Marianna Perna, CCRP

514-934-1934marianna.perna@muhc.mcgill.ca

Locations

McGill University Health Centre--Cedars Cancer Centre

Recruiting

Montreal, Quebec, Canada, H9R 0C8

Contacts

Marianna Perna, CCRP

514-934-1934marianna.perna@muhc.mcgill.ca

Tatiana Carvalho

514-934-1934tatiana.carvalho@muhc.mcgill.ca

Principal Investigator:

Joanne Alfieri, MD

More Information

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Last update posted

Oct 13, 2026

Last verified

Oct, 2026

Keywords

  • Endometrioid cancer
  • Serous clear cell cancer
  • Endometrial carcinosarcoma
  • Dedifferentiated tumours
  • Pelvic radiotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-14. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.