Endometrial CancerHEROSNCT07871838
Safety, Efficacy and Quality of Life After Adjuvant Hypofractionated Radiotherapy for Endometrial Cancer
A study testing Hypo fractionated RT in people with Endometrial Cancer and Endometrial Adenocarcinoma, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer, Endometrial Adenocarcinoma
- What is being tested?
- Hypo fractionated RT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 7 Mar 2025to Aug 2035
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
McGill University Health Centre--Cedars Cancer Centre
Montreal, Quebec, H9R 0C8
Marianna Perna, CCRP, 514-934-1934 ext. 43191, marianna.perna@muhc.mcgill.ca
Tatiana Carvalho, 514-934-1934 ext. 43698, tatiana.carvalho@muhc.mcgill.ca
About this study
Official title: Hypofractionated Endometrial Radiation Outcomes and Safety
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:
Read more
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
Read the detailed description
Uterine endometrial cancer poses a significant cause of morbidity and mortality as the sixth most common malignancy worldwide. The management of non-metastatic EC involves surgery, usually followed by adjuvant radiotherapy and/or adjuvant chemotherapy depending on the risk stratification. Radiation therapy can be delivered in the form of whole pelvic RT (WPRT), vaginal vault brachytherapy (VBT) or a combination of both techniques. Technological advancements now enable us to safely administer doses exceeding 2 Gy per fraction (hypofractionation), which can significantly reduce the treatment duration. By doing this, hypofractionation can save patient's time, reduce costs for the health system and reduce the load in radiotherapy units.
There is limited evidence assessing hypo fractionated regimens in gynecological malignancies, particularly in endometrial cancer. This protocol aims to assess the safety and efficacy of hypo fractionated adjuvant radiotherapy in endometrial cancer treated at the McGill University Health Centre (MUHC), reporting on acute toxicity, late toxicity, oncological outcomes, and quality of life.
- Conditions
- Endometrial Cancer, Endometrial Adenocarcinoma
- Being tested
- Hypo fractionated RT
- Keywords
- Endometrioid cancer, Serous clear cell cancer, Endometrial carcinosarcoma, Dedifferentiated tumours, Pelvic radiotherapy
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypo fractionated RTRadiation
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
| Study group | Role | What they receive |
|---|---|---|
| Study Treatment | Experimental | Hypo fractionated radiotherapy regimen in patients with EC receiving adjuvant WPRT. Receives: Radiation: Hypo fractionated RT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure
Primary outcome: acute and late toxicity rates as measured by CTCAE v5.0. Toxicity will be considered acute if present up to 6 months after treatment and late if present beyond 6 months. Toxicity reports will be released at a median of 3 years of follow-up.
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start7 Mar 2025
- Primary completionAug 2030 (estimated)
- Study completionAug 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joanne Alfieri, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Joanne Alfieri, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871838
- Sponsor's protocol ID
- 2025-10260
- Other IDs
- 2025
- Acronym
- HEROS
- Status last verified
- Oct 2026
- First submitted
- 9 Jul 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Creasman WT, Odicino F, Maisonneuve P, Quinn MA, Beller U, Benedet JL, Heintz AP, Ngan HY, Pecorelli S. Carcinoma of the corpus uteri. FIGO 26th Annual Report on the Results of Treatment in Gynecological Cancer. Int J Gynaecol Obstet. 2006 Nov;95 Suppl 1:S105-43. doi: 10.1016/S0020-7292(06)60031-3. No abstract available.
PubMed 17161155Small W Jr, Bosch WR, Harkenrider MM, Strauss JB, Abu-Rustum N, Albuquerque KV, Beriwal S, Creutzberg CL, Eifel PJ, Erickson BA, Fyles AW, Hentz CL, Jhingran A, Klopp AH, Kunos CA, Mell LK, Portelance L, Powell ME, Viswanathan AN, Yacoub JH, Yashar CM, Winter KA, Gaffney DK. NRG Oncology/RTOG Consensus Guidelines for Delineation of Clinical Target Volume for Intensity Modulated Pelvic Radiation Therapy in Postoperative Treatment of Endometrial and Cervical Cancer: An Update. Int J Radiat Oncol Biol Phys. 2021 Feb 1;109(2):413-424. doi: 10.1016/j.ijrobp.2020.08.061. Epub 2020 Sep 6.
PubMed 32905846Van Limbergen E, Pötter R, Hoskin P, Baltas D. The GEC ESTRO handbook of brachytherapy. Part II Clinical Practice Version. 2019:1-30.
Pecorelli S. Revised FIGO staging for carcinoma of the vulva, cervix, and endometrium. Int J Gynaecol Obstet. 2009 May;105(2):103-4. doi: 10.1016/j.ijgo.2009.02.012. No abstract available.
PubMed 19367689U.S. Department of Health and Human Services. Common Terminology Criteria for Adverse Events (CTCAE). Version 5.0. Nov 27, 2017.
Bacorro W, Baldivia K, Dumago M, Bojador M, Milo A, Trinidad CM, Mariano J, Gonzalez G, Sy Ortin T. Phase 1/2 trial evaluating the effectiveness and safety of dose-adapted Hypofractionated pelvic radiotherapy for Advanced Cervical cancers INeligible for ChemoTherapy (HYACINCT). Acta Oncol. 2022 Jun;61(6):688-697. doi: 10.1080/0284186X.2022.2048070. Epub 2022 Mar 14.
PubMed 35285405Questionnaires: EORTC - Quality of Life. EORTC. (2023, October 10). https://qol.eortc.org/questionnaires/
Marszewska J, Hughes L. How much time is needed to complete quality of life assessments in oncology trials?-Metadata analysis. Cancer Research. 2023 Apr 4;83(7_Supplement):4370-.
Leung EW, Gladwish AP, Davidson MT, Taggar A, Barnes E, Donovan E, Gien LT, Covens A, Vicus D, Kupets R, Han K. Stereotactic Pelvic Adjuvant Radiation Therapy in Cancers of the Uterus (SPARTACUS): A Multicenter Prospective Trial Evaluating Acute Toxicities and Patient Reported Outcomes. International Journal of Radiation Oncology, Biology, Physics. 2021 Nov 1;111(3):S18-9.
Pinitpatcharalert A, Happersett L, Kollmeier M, McBride S, Gorovets D, Tyagi N, Varghese M, Zelefsky MJ. Early Tolerance Outcomes of Stereotactic Hypofractionated Accelerated Radiation Therapy Concomitant with Pelvic Node Irradiation in High-risk Prostate Cancer. Adv Radiat Oncol. 2019 Jan 31;4(2):337-344. doi: 10.1016/j.adro.2018.12.001. eCollection 2019 Apr-Jun.
PubMed 31011679Poon DMC, Yuan J, Yang B, Wong OL, Chiu ST, Chiu G, Cheung KY, Yu SK, Yung RWH. A Prospective Study of Stereotactic Body Radiotherapy (SBRT) with Concomitant Whole-Pelvic Radiotherapy (WPRT) for High-Risk Localized Prostate Cancer Patients Using 1.5 Tesla Magnetic Resonance Guidance: The Preliminary Clinical Outcome. Cancers (Basel). 2022 Jul 18;14(14):3484. doi: 10.3390/cancers14143484.
PubMed 35884553Tree AC, Ostler P, van der Voet H, Chu W, Loblaw A, Ford D, Tolan S, Jain S, Martin A, Staffurth J, Armstrong J, Camilleri P, Kancherla K, Frew J, Chan A, Dayes IS, Duffton A, Brand DH, Henderson D, Morrison K, Brown S, Pugh J, Burnett S, Mahmud M, Hinder V, Naismith O, Hall E, van As N; PACE Trial Investigators. Intensity-modulated radiotherapy versus stereotactic body radiotherapy for prostate cancer (PACE-B): 2-year toxicity results from an open-label, randomised, phase 3, non-inferiority trial. Lancet Oncol. 2022 Oct;23(10):1308-1320. doi: 10.1016/S1470-2045(22)00517-4. Epub 2022 Sep 13.
PubMed 36113498Catton CN, Lukka H, Gu CS, Martin JM, Supiot S, Chung PWM, Bauman GS, Bahary JP, Ahmed S, Cheung P, Tai KH, Wu JS, Parliament MB, Tsakiridis T, Corbett TB, Tang C, Dayes IS, Warde P, Craig TK, Julian JA, Levine MN. Randomized Trial of a Hypofractionated Radiation Regimen for the Treatment of Localized Prostate Cancer. J Clin Oncol. 2017 Jun 10;35(17):1884-1890. doi: 10.1200/JCO.2016.71.7397. Epub 2017 Mar 15.
PubMed 28296582Dearnaley D, Syndikus I, Mossop H, Khoo V, Birtle A, Bloomfield D, Graham J, Kirkbride P, Logue J, Malik Z, Money-Kyrle J, O'Sullivan JM, Panades M, Parker C, Patterson H, Scrase C, Staffurth J, Stockdale A, Tremlett J, Bidmead M, Mayles H, Naismith O, South C, Gao A, Cruickshank C, Hassan S, Pugh J, Griffin C, Hall E; CHHiP Investigators. Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: 5-year outcomes of the randomised, non-inferiority, phase 3 CHHiP trial. Lancet Oncol. 2016 Aug;17(8):1047-1060. doi: 10.1016/S1470-2045(16)30102-4. Epub 2016 Jun 20.
PubMed 27339115Bujko K, Nowacki MP, Nasierowska-Guttmejer A, Michalski W, Bebenek M, Kryj M. Long-term results of a randomized trial comparing preoperative short-course radiotherapy with preoperative conventionally fractionated chemoradiation for rectal cancer. Br J Surg. 2006 Oct;93(10):1215-23. doi: 10.1002/bjs.5506.
PubMed 16983741