a SIngle Center Study of Post-operative STEReotactic RAdiotherapY for Endometrial Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Stereotactic Post-operative Radiotherapy for Endometrial Cancer.
- Who it may be relevant to
- Registry conditions: Endometrial Cancer. Basic parameters: 18 years — 80 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
a SIngle Center Study of Post-operative STEReotactic RAdiotherapY for Endometrial Cancer (SISTER-RAY)
Overview
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.
Interventions
- 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.
Primary outcome measures
- Acute G3 or higher Gastrointestinal and Genitourinary Toxicity [Time frame: From the end of treatment to a time interval of 12 weeks]
Secondary outcome measures (5)
- Late Gastrointestinal and Genitourinary Toxicity [Time frame: From enrollment to a follow-up time of 5 years]
- Distant Progression Free Survival [Time frame: From enrollment to a follow-up time of 5 years]
- Local Control [Time frame: From enrollment to a follow-up time of 5 years]
- Overall Survival [Time frame: From enrollment to a follow-up time of 5 years]
- Overall Quality of Life [Time frame: From enrollment to a follow-up time of 5 years]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 2 centers
- ARNAS Civico Hospital — Palermo
- ARNAS Civico Hospital — Palermo
Publications
- 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 PMID 35420695
- 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.i PMID 30071295
- 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 23582248
Identifiers
NCT: NCT06360653 · 76CIVICO2023