ClinicalTrials.gg
RecruitingNCT07871838HEROSUpdated Oct 13, 2026

Safety, Efficacy and Quality of Life After Adjuvant Hypofractionated Radiotherapy for Endometrial Cancer

An interventional study of Hypo fractionated RT in Endometrial Cancer and Endometrial Adenocarcinoma, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Recruiting at 1 site in Canada. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Mar 2025, registered Jul 2026).
  • Started Mar 2025; still recruiting 1 year 7 months later.
Updated Oct 13, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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
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.

02

Conditions studied

  • Endometrial Cancer
  • Endometrial Adenocarcinoma

Keywords

  • Endometrioid cancer
  • Serous clear cell cancer
  • Endometrial carcinosarcoma
  • Dedifferentiated tumours
  • Pelvic radiotherapy
03

In context

Endometrial Neoplasms

1,347 studies on the registry are indexed under Endometrial Neoplasms; 452 are open to participants now.

This study's planned enrollment of 50 is below the median of 70 across 954 interventional studies indexed under Endometrial Neoplasms.

Browse Endometrial Neoplasms studies →

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 420 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Study Treatment

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

    Radiation: Hypo fractionated RT

Interventions

  • RadiationHypo 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Three years

07

Study locations

1 of 1 sites recruiting
  • McGill University Health Centre--Cedars Cancer Centre
    Montreal, Quebec H9R 0C8, Canada
    Recruiting
08

References and documents

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 17161155 ↗
  • Small 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 32905846 ↗
  • Van 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 19367689 ↗
  • U.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 35285405 ↗
  • Questionnaires: 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 31011679 ↗
  • Poon 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 35884553 ↗
  • Tree 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 36113498 ↗
  • Catton 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 28296582 ↗
  • Dearnaley 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 27339115 ↗
  • Bujko 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 ↗
  • Folkesson J, Birgisson H, Pahlman L, Cedermark B, Glimelius B, Gunnarsson U. Swedish Rectal Cancer Trial: long lasting benefits from radiotherapy on survival and local recurrence rate. J Clin Oncol. 2005 Aug 20;23(24):5644-50. doi: 10.1200/JCO.2005.08.144. PubMed 16110023 ↗
  • Murray Brunt A, Haviland JS, Wheatley DA, Sydenham MA, Alhasso A, Bloomfield DJ, Chan C, Churn M, Cleator S, Coles CE, Goodman A, Harnett A, Hopwood P, Kirby AM, Kirwan CC, Morris C, Nabi Z, Sawyer E, Somaiah N, Stones L, Syndikus I, Bliss JM, Yarnold JR; FAST-Forward Trial Management Group. Hypofractionated breast radiotherapy for 1 week versus 3 weeks (FAST-Forward): 5-year efficacy and late normal tissue effects results from a multicentre, non-inferiority, randomised, phase 3 trial. Lancet. 2020 May 23;395(10237):1613-1626. doi: 10.1016/S0140-6736(20)30932-6. Epub 2020 Apr 28. PubMed 32580883 ↗
  • Haviland JS, Owen JR, Dewar JA, Agrawal RK, Barrett J, Barrett-Lee PJ, Dobbs HJ, Hopwood P, Lawton PA, Magee BJ, Mills J, Simmons S, Sydenham MA, Venables K, Bliss JM, Yarnold JR; START Trialists' Group. The UK Standardisation of Breast Radiotherapy (START) trials of radiotherapy hypofractionation for treatment of early breast cancer: 10-year follow-up results of two randomised controlled trials. Lancet Oncol. 2013 Oct;14(11):1086-1094. doi: 10.1016/S1470-2045(13)70386-3. Epub 2013 Sep 19. PubMed 24055415 ↗
  • Hennequin C, Guillerm S, Quero L. Rationale for hypofractionation. Cancer Radiother. 2019 Oct;23(6-7):500-502. doi: 10.1016/j.canrad.2019.07.156. Epub 2019 Aug 20. PubMed 31444076 ↗
  • Concin N, Matias-Guiu X, Vergote I, Cibula D, Mirza MR, Marnitz S, Ledermann J, Bosse T, Chargari C, Fagotti A, Fotopoulou C, Martin AG, Lax S, Lorusso D, Marth C, Morice P, Nout RA, O'Donnell D, Querleu D, Raspollini MR, Sehouli J, Sturdza A, Taylor A, Westermann A, Wimberger P, Colombo N, Planchamp F, Creutzberg CL. ESGO/ESTRO/ESP guidelines for the management of patients with endometrial carcinoma. Radiother Oncol. 2021 Jan;154:327-353. doi: 10.1016/j.radonc.2020.11.018. PubMed 33712263 ↗
  • Mahdy H, Vadakekut ES, Crotzer D. Endometrial Cancer. 2024 Apr 20. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK525981/ PubMed 30252237 ↗
  • Leung E, Gladwish AP, Davidson M, Taggar A, Velker V, Barnes E, Mendez L, Donovan E, Gien LT, Covens A, Vicus D, Kupets R, MacKay H, Han K, Cheung P, Zhang L, Loblaw A, D'Souza DP. Quality-of-Life Outcomes and Toxic Effects Among Patients With Cancers of the Uterus Treated With Stereotactic Pelvic Adjuvant Radiation Therapy: The SPARTACUS Phase 1/2 Nonrandomized Controlled Trial. JAMA Oncol. 2022 Jun 1;8(6):1-9. doi: 10.1001/jamaoncol.2022.0362. PubMed 35420695 ↗
09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2025 (actual). Primary completion is estimated for Aug 2030, 65 months after the start.

Of 187 non-industry interventional studies with no phase under Endometrial Neoplasms, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 63. This study's planned 65 months is above that.

Counting every sponsor, half of 192 studies reached it within 36 months; a quarter within 19 and three quarters within 63.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 9, 2026
First posted
Oct 13, 2026
StartActual
Mar 7, 2025
Primary completionEst.
Aug 2030
CompletionEst.
Aug 2035
Last update
Oct 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07871838
Responsible party
Joanne Alfieri (Principal Investigator/Radiation Oncologist, McGill University Health Centre/Research Institute of the McGill University Health Centre) — Principal investigator
First posted
Oct 13, 2026
Start date
Mar 7, 2025
Primary completion
Aug 2030 (estimated)
Completion
Aug 2035 (estimated)
Last update
Oct 13, 2026

Study contacts

Joanne Alfieri, MD
Contact
joanne.alfieri@ssss.gouv.qc.ca
514-934-1934
Marianna Perna, CCRP
Contact
marianna.perna@muhc.mcgill.ca
514-934-1934 ext. 43191
Joanne Alfieri, MD
principal investigator · McGill University Health Centre/Research Institute of the McGill University Health Centre

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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