Clinical trial NCT04890912: Stereotactic Pelvic Adjuvant Radiation Therapy in Cancers of the Uterus II
Official title: Stereotactic Pelvic Adjuvant Radiation Therapy in Cancers of the Uterus II: A Phase II Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endometrial Cancer
Keywords: endometrial cancer
uterine cancer
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Princess Margaret Hospital, Canada
name: Royal Victoria Hospital, Canada
name: Credit Valley Hospital
name: London Regional Cancer Program, Canada
First posted: 2021-05-18
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Acute bowel toxicity
timeFrame: Baseline to 2 years following RT completion
Secondary outcomes:
measure: Acute bowel toxicities
timeFrame: Baseline to 2 years following RT completion
measure: Acute urinary toxicities through CTCAE
timeFrame: Baseline to 2 years following RT completion
measure: Acute urinary toxicities through EPIC
timeFrame: Baseline to 2 years following RT completion
measure: Local- regional failure
timeFrame: Baseline to 2 years following RT completion
measure: Disease-free survival
timeFrame: Baseline to 2 years following RT completion
measure: Quality of life using EORTC QLQ-30 and endometrial module (EN-24)
timeFrame: Baseline to 2 years following RT completion
measure: Correlation of GU toxicity, EORTC, and EPIC
timeFrame: Baseline to 2 years following RT completion
Other outcomes:
Locations:
city: Barrie
country: Canada
facility: Royal Victoria Hospital
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Program
state: Ontario
city: Mississauga
country: Canada
facility: Credit Valley Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Eric Leung, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Princess Margaret Cancer Centre
name: Kathy Han, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Victoria Hospital, Belfast
name: Adam Gladwish, MD
role: PRINCIPAL_INVESTIGATOR
References: