NCT06360653

Brief Summary

The primary endpoint of the present prospective study is to assess the outcomes in terms of acute toxicity of post-operative stereotactic radiotherapy for endometrial cancer

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
12mo left

Started May 2025

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
May 2025May 2027

First Submitted

Initial submission to the registry

April 5, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 11, 2024

Completed
1.1 years until next milestone

Study Start

First participant enrolled

May 2, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Expected
Last Updated

June 25, 2025

Status Verified

May 1, 2025

Enrollment Period

12 months

First QC Date

April 5, 2024

Last Update Submit

June 20, 2025

Conditions

Endometrial Cancer

Keywords

endometrial cancerradiotherapysbrt

Outcome Measures

Primary Outcomes (1)

  • Acute G3 or higher Gastrointestinal and Genitourinary Toxicity

    The number of any G3 or higher adverse event occurring within 90 days from the end of radiotherapy and assessed according to the CTCAE v5.0 criteria

    From the end of treatment to a time interval of 12 weeks

Secondary Outcomes (5)

  • Late Gastrointestinal and Genitourinary Toxicity

    From enrollment to a follow-up time of 5 years

  • Distant Progression Free Survival

    From enrollment to a follow-up time of 5 years

  • Local Control

    From enrollment to a follow-up time of 5 years

  • Overall Survival

    From enrollment to a follow-up time of 5 years

  • Overall Quality of Life

    From enrollment to a follow-up time of 5 years

Study Arms (1)

Experimental arm

EXPERIMENTAL

Patients with endometrial cancer (stage IB-IIIC1) with histological and molecular features that require adjuvant external beam radiotherapy alone or in combination with chemotherapy and/or brachytherapy. Adjuvant radiotherapy will be performed with stereotactic body radiotherapy schedule of 30 Gy in 5 sessions.

Radiation: Stereotactic Post-operative Radiotherapy for Endometrial Cancer

Interventions

Stereotactic Post-operative Radiotherapy for Endometrial CancerRADIATION

Patients candidate to receive adjuvant radiotherapy will be assigned to a shorter schedule of 30 Gy in 5 sessions.

Experimental arm

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Written Informed Consent
  • Prior pelvic radiotherapy
  • Para-aortic lymph nodes involvement
  • ECOG PS ≥ 3
  • Any diagnosis of inflammatory bowel disease (both active or quiescent)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

ARNAS Civico Hospital

Palermo, 90100, Italy

NOT YET RECRUITING

ARNAS Civico Hospital

Palermo, Italy

RECRUITING

Related Publications (3)

  • Leung E, Gladwish AP, Davidson M, Taggar A, Velker V, Barnes E, Mendez L, Donovan E, Gien LT, Covens A, Vicus D, Kupets R, MacKay H, Han K, Cheung P, Zhang L, Loblaw A, D'Souza DP. Quality-of-Life Outcomes and Toxic Effects Among Patients With Cancers of the Uterus Treated With Stereotactic Pelvic Adjuvant Radiation Therapy: The SPARTACUS Phase 1/2 Nonrandomized Controlled Trial. JAMA Oncol. 2022 Jun 1;8(6):1-9. doi: 10.1001/jamaoncol.2022.0362.

    PMID: 35420695BACKGROUND

  • Musunuru HB, D'Alimonte L, Davidson M, Ho L, Cheung P, Vesprini D, Liu S, Chu W, Chung H, Ravi A, Deabreu A, Zhang L, Commisso K, Loblaw A. Phase 1-2 Study of Stereotactic Ablative Radiotherapy Including Regional Lymph Node Irradiation in Patients With High-Risk Prostate Cancer (SATURN): Early Toxicity and Quality of Life. Int J Radiat Oncol Biol Phys. 2018 Dec 1;102(5):1438-1447. doi: 10.1016/j.ijrobp.2018.07.2005. Epub 2018 Jul 31.

    PMID: 30071295BACKGROUND

  • Klopp AH, Moughan J, Portelance L, Miller BE, Salehpour MR, Hildebrandt E, Nuanjing J, D'Souza D, Souhami L, Small W Jr, Gaur R, Jhingran A. Hematologic toxicity in RTOG 0418: a phase 2 study of postoperative IMRT for gynecologic cancer. Int J Radiat Oncol Biol Phys. 2013 May 1;86(1):83-90. doi: 10.1016/j.ijrobp.2013.01.017.

    PMID: 23582248BACKGROUND

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

FRANCESCO CUCCIA, MD

CONTACT

+393334393336francesco.cuccia@arnascivico.it

GIUSEPPE FERRERA, MD

CONTACT

+393471533715giuseppe.ferrera@arnascivico.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 5, 2024

First Posted

April 11, 2024

Study Start

May 2, 2025

Primary Completion

May 1, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

June 25, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(2)