Clinical trial · Interventional
a SIngle Center Study of Post-operative STEReotactic RAdiotherapY for Endometrial Cancer
a SIngle Center Study of Post-operative STEReotactic RAdiotherapY for Endometrial Cancer (SISTER-RAY)
NCT06360653CI-TRIAL-00091328SISTER-RAYrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Post-operative Radiotherapy for Endometrial Cancer | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental arm
- description
- 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.
- interventionNames
- Radiation: Stereotactic Post-operative Radiotherapy for Endometrial Cancer
Primary outcomes (1)
- measure
- Acute G3 or higher Gastrointestinal and Genitourinary Toxicity
- timeFrame
- From the end of treatment to a time interval of 12 weeks
- description
- 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
Secondary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
* 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)
References
Publications (3)
- RESULTLeung 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 35420695
- RESULTMusunuru 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 30071295
- RESULTKlopp 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