Adjuvant Stereotactic Pelvic Irradiation in Endometrial Cancer

Endometrial Cancer Clinical Trial

— ASPIRE  

Official title:

Adjuvant Stereotactic Pelvic Irradiation in Endometrial Cancer (ASPIRE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04235179
• Other study ID #: E-19-4466
• Status: Recruiting
• Phase: Phase 2
• Start date: January 16, 2020
• Est. completion date: January 2026

Study information

• Verified date: January 2020
• Source: King Saud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 2026
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Radiation:
• SABR
SABR to a dose of 30Gy/5 to the pelvis (vaginal and paravaginal tissues as well as regional lymph nodes)

Locations

Country	Name	City	State
Saudi Arabia	King Saud University Medical City	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
King Saud University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Treatment-Related Adverse Events	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	3 months after accrual is completed
Secondary	Late Treatment-Related Adverse Events	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	5 years after accrual is completed
Secondary	Disease Local-Regional Failure Rate	The rate of local-regional failure of the disease in participants after adjuvant SABR treatment in the setting of high-risk endometrial cancer.	5 years after accrual is completed
Secondary	Quality of Life	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.	5 years after accrual is completed