Adjuvant Stereotactic Pelvic Irradiation in Endometrial Cancer

Phase 2

Recruiting

• Conditions: Endometrial Cancer
• Interventions: Radiation: SABR

• Registration Number: NCT04235179
• Lead Sponsor: King Saud University

Brief Summary

Stereotactic Ablative Radiation (SABR/SBRT) will be prescribed to a dose of 30 Gy in 5 fractions, once weekly to the pelvis in post operative patients with endometrial cancer.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-01
• Study Start: 2020-01-16
• Study First Submitted: 2020-01-16
• Study First Submitted QC: 2020-01-16
• Last Update Submitted: 2020-01-19
• Study First Posted: 2020-01-21
• Last Update Posted: 2020-01-22
• Primary Completion: 2022-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Patient with histologically confirmed endometrial adenocarcinoma
• Patient is a candidate for adjuvant pelvic radiation (+/- vault brachytherapy), meeting one of the following conditions: High grade histology OR Outer-half myometrial invasion with any risk factors OR FIGO stage II - IIIC1.
• Age ≥18 years.
• Patients who are to receive adjuvant systemic therapy in addition to pelvic radiotherapy will be eligible provided that there is at minimum a 3-week interval between any radiation treatment and chemotherapy treatments.

Exclusion Criteria

• Patient has had prior pelvic radiotherapy.
• Patient has Type II endometrial cancer histology (ie. Serous, clear cell or carcinosarcoma).
• Patient has a contraindication to pelvic radiotherapy, such as but not limited to a connective tissue disease or inflammatory bowel disease.
• Patient has a contraindication to CT contrast.
• Patient has a hip prosthesis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SABR	SABR	Pelvic SABR for post-op endometrial cancer

Primary Outcome Measures

Name	Time	Method
Acute Treatment-Related Adverse Events	3 months after accrual is completed	The number of participants with acute (\<3 months) urinary and bowel treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) criteria

Secondary Outcome Measures

Name	Time	Method
Late Treatment-Related Adverse Events	5 years after accrual is completed	The number of participants with late (\>3 months) urinary and bowel treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) criteria
Disease Local-Regional Failure Rate	5 years after accrual is completed	The rate of local-regional failure of the disease in participants after adjuvant SABR treatment in the setting of high-risk endometrial cancer.
Quality of Life	5 years after accrual is completed	The mean decrease in Quality of Life in participants after adjuvant SBRT treatment using EORTC (European Organisation for Research and Treatment of Cancer) core questionnaire (QLQ-C30) with EN-24 companion.

Trial Locations

Locations (1)

King Saud University Medical City; 🇸🇦 Riyadh, Saudi Arabia