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| Name | Class |
|---|---|
| Accuray Incorporated | INDUSTRY |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Post-operative Radiotherapy for Endometrial Cancer | Radiation | Patients candidate to receive adjuvant radiotherapy will be assigned to a shorter schedule of 30 Gy in 5 sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Distant Progression Free Survival |
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| FRANCESCO CUCCIA, MD | Contact | +393334393336 | francesco.cuccia@arnascivico.it | |
| GIUSEPPE FERRERA, MD | Contact | +393471533715 | giuseppe.ferrera@arnascivico.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ARNAS Civico Hospital | Not yet recruiting | Palermo | 90100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35420695 | Result | 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. | |
| 30071295 |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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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 |
| 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 |
| Overall Survival | The rate of death events in the cohort of patients enrolled | From enrollment to a follow-up time of 5 years |
| 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 |
| ARNAS Civico Hospital | Recruiting | Palermo | Italy |
|
| Result |
| 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. |
| 23582248 | Result | 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. |
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |