a SIngle Center Study of Post-operative STEReotactic RAdiotherapY for Endometrial Cancer
NCT ID: NCT06360653
Last Updated: 2025-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-05-02
2027-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Experimental arm
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.
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.
Interventions
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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.
Eligibility Criteria
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Exclusion Criteria
* Prior pelvic radiotherapy
* Para-aortic lymph nodes involvement
* ECOG PS ≥ 3
* Any diagnosis of inflammatory bowel disease (both active or quiescent)
18 Years
80 Years
FEMALE
No
Sponsors
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Accuray Incorporated
INDUSTRY
ARNAS Civico Di Cristina Benfratelli Hospital
OTHER
Responsible Party
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Francesco Cuccia, MD
Principal Investigator
Locations
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ARNAS Civico Hospital
Palermo, , Italy
ARNAS Civico Hospital
Palermo, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Other Identifiers
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76CIVICO2023
Identifier Type: -
Identifier Source: org_study_id
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