a SIngle Center Study of Post-operative STEReotactic RAdiotherapY for Endometrial Cancer

Endometrial Cancer Clinical Trial

— SISTER-RAY  

Official title:

a SIngle Center Study of Post-operative STEReotactic RAdiotherapY for Endometrial Cancer (SISTER-RAY)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06360653
• Other study ID #: 76CIVICO2023
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: June 2026

Study information

• Verified date: April 2024
• Source: ARNAS Civico Di Cristina Benfratelli Hospital
• Contact: FRANCESCO CUCCIA, MD
• Phone: +393334393336
• Email: francesco.cuccia[@]arnascivico.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Endometrial cancer represents the sixth global female cancer, and adjuvant radiotherapy has a main role in the management of these patients.

This treatment usually covers the surgical bed, the upper portion of the vagina and the pelvic lymph nodes. In the last decades, the technological progress has allowed clinicians to offer a more accurate planning and delivery of the treatment with modern IMRT-IGRT techniques.

Nonetheless, radiotherapy regimens were still based on 25-30 fractions schedules. More recently, similarly to other oncological settings like prostate, breast or rectal cancer, 5-fractions schedules have been considered as potentially useful also in this setting.

On this purpose, this study aims to investigate the feasibility of a shorter adjuvant radiotherapy treatment for endometrial cancer, by assessing acute and late toxicity, quality of life and clinical outcomes.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 2026
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

• Age 18-80 years

• ECOG PS = 2 or KPS = 70%

• Patients diagnosed with endometrial cancer (endometrioid, serous cell, clear cell, carcinosarcoma) FIGO stage IB-IIIC1 candidate to post-operative external beam radiotherapy, based on molecular and histological findings

• Indications for chemotherapy and/or brachytherapy are not exclusion criteria for the purpose of the study

• Written Informed Consent

Exclusion Criteria:

• Prior pelvic radiotherapy

• Para-aortic lymph nodes involvement

• ECOG PS = 3

• Any diagnosis of inflammatory bowel disease (both active or quiescent)

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Radiation:
• Stereotactic Post-operative Radiotherapy for Endometrial Cancer
Patients candidate to receive adjuvant radiotherapy will be assigned to a shorter schedule of 30 Gy in 5 sessions.

Locations

Country	Name	City	State
Italy	ARNAS Civico Hospital	Palermo	PA

Sponsors (1)

Lead Sponsor	Collaborator
ARNAS Civico Di Cristina Benfratelli Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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 Onco — View Citation

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 — View Citation

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 Hi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Late Gastrointestinal and Genitourinary Toxicity	The number of any G3 or higher adverse event occurring after 90 days from the end of radiotherapy and assessed according to the CTCAE v5.0 criteria	From enrollment to a follow-up time of 5 years
Secondary	Distant Progression Free Survival	The rate of distant failure of the disease in all the participants enrolled for adjuvant SBRT	From enrollment to a follow-up time of 5 years
Secondary	Local Control	The rate of local failure of the disease in all the participants enrolled for adjuvant SBRT	From enrollment to a follow-up time of 5 years
Secondary	Overall Survival	The rate of death events in the cohort of patients enrolled	From enrollment to a follow-up time of 5 years
Secondary	Overall Quality of Life	The mean values of Quality of life questionnaires performed at baseline and at 3-6-12-18-24-36- 48-60 months from the end of treatment, with the QLQ-C30 and QLQ-EN24 fulfilled by all patients enrolled	From enrollment to a follow-up time of 5 years