Recruiting

Stereotactic Radiation

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT04890912

Conditions

Endometrial Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Conventional Fractionation

Hypofractionation

Study Details

Brief summary:

Adjuvant radiotherapy (RT) plays an important role in reducing the risks of local recurrence after surgery in uterine cancers. Standard adjuvant pelvic radiation treatment targets the pelvic lymph nodes, the post-operative bed, and the upper vagina and is typically treated with intensity modulated radiation therapy (IMRT) which has been shown to improve patient reported gastrointestinal (GI) and genitourinary (GU) toxicities. Although pelvic radiation has been shown to be effective at decreasing locoregional recurrences, patient quality of life and experience can be significantly impacted as pelvic RT comprises of daily radiation for 25 daily treatments, which can be a substantial burden on patients with this disease. Hypofractionated radiotherapy to a dose of 30 Gy in 5 fractions (6 Gy given every other day) for adjuvant radiation treatment in uterine cancer is hypothesized to result in similar rates of acute gastrointestinal toxicities as conventional fractionated radiation.

Conditions

Endometrial Cancer

Study ID

NCT04890912

Start date

Jul 15, 2021

Status verified date

Oct, 2021

Completion date

Jun 1, 2023

Anticipated

Primary completion date

Jun 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Patient with histologically confirmed endometrial adenocarcinoma, serous or clear cell carcinoma.
2. Patient is a candidate for adjuvant pelvic radiation for uterine cancer (+/- vault brachytherapy), meeting one of the following conditions:

High grade histology (including serous and clear cell) OR Outer-half myometrial invasion and International Federation of Gynecology and Obstetrics (FIGO) grade 1-2 OR FIGO stage II - III.
3. Patients who are to receive adjuvant systemic therapy sequentially in addition to pelvic radiotherapy will be eligible.
4. Age ≥18 years.
5. Patient is willing and able to give informed consent to participate in this clinical trial.

Exclusion Criteria:

1. Patient has had prior pelvic radiotherapy.
2. Patient has a contraindication to pelvic radiotherapy, such as but not limited to a connective tissue disease or inflammatory bowel disease.
3. Patient planned for concurrent chemoradiation therapy.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Conventional Fractionation Pelvic Radiation

Patients randomized to the conventional fractionation arm will be treated with intensity-modulated or volumetric arc therapy technique as per standard protocol.

experimental: Stereotactic Hypofractionated Radiation

Patients randomized to hypofractionation will be treated the stereotactic hypofractionated technique.

Interventions

Conventional Fractionation

Dose prescribed is 45 Gy in 25 fractions (1.8 Gy per fraction) delivered daily over 5 weeks.

Hypofractionation

Dose prescribed is 30 Gy in 5 fractions (6 Gy per fraction) delivered every other day over 11 days. There will be a minimum of 36 hours and maximum of 96 hours between fractions. The entire course of treatment should be completed within no less than 10 days.

Primary outcome measure

  • Acute bowel toxicity [ Time Frame: Baseline to 2 years following RT completion ]

Central Contacts and Locations

Central contacts

Anika Mohan

416-480-5000anika.mohan@sunnybrook.ca

Nithla Mohanathas

416-480-5000nithla.mohanathas@sunnybrook.ca

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Anika Mohan

anika.mohan@sunnybrook.ca

Principal Investigator:

Eric Leung, MD

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Oct 25, 2021

Last verified

Oct, 2021

Keywords

  • endometrial cancer
  • uterine cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2021-10-25.