Adjuvant Stereotactic Pelvic Irradiation in Endometrial Cancer

NCT04235179 | Unknown Phase 2

• 1 other identifier: E-19-4466
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Late Treatment-Related Adverse Events

  5 years after accrual is completed

• Disease Local-Regional Failure Rate

  5 years after accrual is completed

• Quality of Life

  5 years after accrual is completed

Study Arms (1)

SABR

EXPERIMENTAL

Pelvic SABR for post-op endometrial cancer

Radiation: SABR

Interventions

SABR RADIATION

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

SABR

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Saud University: lead

Study Sites (1)

King Saud University Medical City

Riyadh, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant and Assistant Professor

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: January 21, 2020
• Study Start: January 16, 2020
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2026
• Last Updated: January 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)