Clinical trial NCT06360653: a SIngle Center Study of Post-operative STEReotactic RAdiotherapY for Endometrial Cancer
Official title: a SIngle Center Study of Post-operative STEReotactic RAdiotherapY for Endometrial Cancer (SISTER-RAY)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Endometrial Cancer
Keywords: endometrial cancer
radiotherapy
sbrt
Lead sponsor: ARNAS Civico Di Cristina Benfratelli Hospital
Sponsor class: OTHER
Collaborators: name: Accuray Incorporated
First posted: 2024-04-11
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: * 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)

Primary outcomes:
measure: Acute G3 or higher Gastrointestinal and Genitourinary Toxicity
timeFrame: From the end of treatment to a time interval of 12 weeks
Secondary outcomes:
measure: Late Gastrointestinal and Genitourinary Toxicity
timeFrame: From enrollment to a follow-up time of 5 years
measure: Distant Progression Free Survival
timeFrame: From enrollment to a follow-up time of 5 years
measure: Local Control
timeFrame: From enrollment to a follow-up time of 5 years
measure: Overall Survival
timeFrame: From enrollment to a follow-up time of 5 years
measure: Overall Quality of Life
timeFrame: From enrollment to a follow-up time of 5 years
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: ARNAS Civico Hospital
state: PA
Study officials:
References:
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 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.
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 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.
citation: 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.