Gynecologic CancerGYN-ARTNCT06306170
Advanced Radiotherapy (ART) in Gynecological Cancer Patients (GYN-ART)
An observational study of Gynecologic Cancer and Radiotherapy Side Effect, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
This is an observational mono-institutional study. Patients with gynecologic tumors treated with advanced radiotherapy- Image Guided Radiotherapy (IGRT), Intensity Modulated Radiotherapy (IMRT), Stereotactic Body Radiotherapy (SBRT)- will be included and toxicity and outcomes analyzed. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Gynecologic Cancer, Radiotherapy Side Effect, Radiotherapy; Complications
- What is being tested?
- Image Guided Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- 15 Feb 2024to 15 Feb 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- Adult, Older adult
Study population: Gynecologic cancer patients, > 18 years old, treated with IGRT, IMRT, SBRT
Who may be able to join
- gynecologic cancer patients
- >18 years old
- treated with advanced radiotherapy techniques (IGRT, IMRT, SBRT)
Who cannot join
- other tumors
- > 90 years old
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
San Raffaele Scientific Institute
Milan, MI, 20132
Andrei Fodor, M.D., +390226437634, fodor.andrei@hsr.it
Nadia G Di Muzio, Prof, +390226437643, dimuzio.nadia@hsr.it
About this study
Official title: Efficacy of Advanced Radiotherapy (ART) in Gynecological Cancer Patients (GYN-ART)
This is an observational mono-institutional study. Patients with gynecologic tumors treated with advanced radiotherapy- Image Guided Radiotherapy (IGRT), Intensity Modulated Radiotherapy (IMRT), Stereotactic Body Radiotherapy (SBRT)- will be included and toxicity and outcomes analyzed.
Read the detailed description
The patients with gynecological cancer treated with Advanced Radiotherapy (ART)- Image Guided Radiotherapy (IGRT), Intensity Modulated Radiotherapy (IMRT), Stereotactic Body Radiotherapy (SBRT)- at the Department of Radiotherapy of "IRCCS San Raffaele Scientific Institute" (IRCCSSRaffaele) from January 2005 to January 2024 will be identified and their clinical and dosimetric data retrieved and analyzed.
The study objectives are the analysis of acute and late toxicity, and clinical outcomes, such as local, regional and distant control,disease free survival, cancer-specific survival, and overall survival. Secondary objective is the identification of prognostic factors for toxicity, disease progression, survival, including radiomic characteristics.
- Conditions
- Gynecologic Cancer, Radiotherapy Side Effect, Radiotherapy; Complications, Survivorship, Progression, Disease, Progression, Clinical
- Being tested
- Image Guided Radiotherapy
- Keywords
- Gynecologic Cancer, Image Guided Radiotherapy, PET/CT, Intensity Modulated Radiotherapy, Stereotactic Body Radiotherapy, Oligometastases
- Medical subject headings
- Radiation Injuries, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Image Guided RadiotherapyRadiation
Also called Intensity Modulated Radiotherapy, Stereotactic Body Radiotherapy
Patients treated with IGRT, IMRT, SBRT for Gynecological cancer will be evaluated
| Study group | Role | What they receive |
|---|---|---|
| Gynecologic cancer patients | Gynecologic cancer patients treated with IGRT, IMRT, SBRT (advanced radiotherapy-ART) Receives: Radiation: Image Guided Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Relapse Free Survival
local control (on the treated site) of the disease
Measured: From date of radiotherapy end until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
Regional Relapse Free Survival
regional control (regional lymph nodal chain) of the disease
Measured: From date of radiotherapy end until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
Distant Metastases Free Survival
distant metastases developed after the treatment
Measured: From date of radiotherapy end until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
Disease Free Survival
absence of disease progression during the follow-up
Measured: From date of radiotherapy end until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
Overall Survival
survival from all causes
Measured: From date of radiotherapy end until the date of death from any cause, assessed up to 120 months
Cancer Specific Survival
cancer survival
Measured: From date of radiotherapy end until the date of death from disease progression, assessed up to 120 months
Secondary outcomes (2)
Acute toxicity
Toxicity developed in the first three months after the treatment, assessed with Common Terminology Criteria for Adverse Events (CTCAE) v5.0 scale, which displayes grades from 1 to 5, with grade 1 meaning mild toxicity and grade 5 death related to toxicity
Measured: Up to three months from the start of radiotherapy
Late toxicity
Toxicity developed after three months until the end of follow-up or death, assessed with Common Terminology Criteria for Adverse Events (CTCAE) v5.0 scale, assessed with Common Terminology Criteria for Adverse Events (CTCAE) v5.0 scale, which displayes grades from 1 to 5, with grade 1 meaning mild toxicity and grade 5 death related to toxicity
Measured: From three months after the start of radiotherapy until the end of follow-up or death, assessed up to 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start15 Feb 2024
- Primary completion15 Feb 2027 (estimated)
- Study completion15 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrei Fodor, MD, IRCCS San Raffaele
- Investigators
- andrei Fodor, MD, Principal investigator, IRCCS San Raffaele Scientific Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06306170
- Sponsor's protocol ID
- GYN-ART
- Acronym
- GYN-ART
- Status last verified
- Oct 2026
- First submitted
- 14 Feb 2024
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data that support the findings of this study (anonymized individual participant data) are available on request from the corresponding author to researchers who provide a methodologically sound proposal. Requests made to the corresponding author (AF) will be evaluated by the Lombardy Territorial Ethics Committee
Publications
Gavinski K, DiNardo D. Cervical Cancer Screening. Med Clin North Am. 2023 Mar;107(2):259-269. doi: 10.1016/j.mcna.2022.10.006. Epub 2022 Dec 26.
PubMed 36759096Stewart C, Ralyea C, Lockwood S. Ovarian Cancer: An Integrated Review. Semin Oncol Nurs. 2019 Apr;35(2):151-156. doi: 10.1016/j.soncn.2019.02.001. Epub 2019 Mar 11.
PubMed 30867104Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022 Jan;72(1):7-33. doi: 10.3322/caac.21708. Epub 2022 Jan 12.
PubMed 35020204Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PubMed 33538338Makker V, MacKay H, Ray-Coquard I, Levine DA, Westin SN, Aoki D, Oaknin A. Endometrial cancer. Nat Rev Dis Primers. 2021 Dec 9;7(1):88. doi: 10.1038/s41572-021-00324-8.
PubMed 34887451Berek JS, Matias-Guiu X, Creutzberg C, Fotopoulou C, Gaffney D, Kehoe S, Lindemann K, Mutch D, Concin N; Endometrial Cancer Staging Subcommittee, FIGO Women's Cancer Committee. FIGO staging of endometrial cancer: 2023. Int J Gynaecol Obstet. 2023 Aug;162(2):383-394. doi: 10.1002/ijgo.14923. Epub 2023 Jun 20.
PubMed 37337978Guckenberger M, Lievens Y, Bouma AB, Collette L, Dekker A, deSouza NM, Dingemans AC, Fournier B, Hurkmans C, Lecouvet FE, Meattini I, Mendez Romero A, Ricardi U, Russell NS, Schanne DH, Scorsetti M, Tombal B, Verellen D, Verfaillie C, Ost P. Characterisation and classification of oligometastatic disease: a European Society for Radiotherapy and Oncology and European Organisation for Research and Treatment of Cancer consensus recommendation. Lancet Oncol. 2020 Jan;21(1):e18-e28. doi: 10.1016/S1470-2045(19)30718-1.
PubMed 31908301Colombo N, Creutzberg C, Amant F, Bosse T, Gonzalez-Martin A, Ledermann J, Marth C, Nout R, Querleu D, Mirza MR, Sessa C; ESMO-ESGO-ESTRO Endometrial Consensus Conference Working Group. ESMO-ESGO-ESTRO Consensus Conference on Endometrial Cancer: diagnosis, treatment and follow-up. Ann Oncol. 2016 Jan;27(1):16-41. doi: 10.1093/annonc/mdv484. Epub 2015 Dec 2.
PubMed 26634381Tortorella L, Restaino S, Zannoni GF, Vizzielli G, Chiantera V, Cappuccio S, Gioe A, La Fera E, Dinoi G, Angelico G, Scambia G, Fanfani F. Substantial lymph-vascular space invasion (LVSI) as predictor of distant relapse and poor prognosis in low-risk early-stage endometrial cancer. J Gynecol Oncol. 2021 Mar;32(2):e11. doi: 10.3802/jgo.2021.32.e11. Epub 2021 Jan 11.
PubMed 33470061Ramanathan S, Tirumani SH, Ojili V. Nodal metastasis in gynecologic malignancies: Update on imaging and management. Clin Imaging. 2020 Feb;59(2):157-166. doi: 10.1016/j.clinimag.2019.11.006. Epub 2019 Nov 28.
PubMed 31821973Milam MR, Java J, Walker JL, Metzinger DS, Parker LP, Coleman RL; Gynecologic Oncology Group. Nodal metastasis risk in endometrioid endometrial cancer. Obstet Gynecol. 2012 Feb;119(2 Pt 1):286-92. doi: 10.1097/AOG.0b013e318240de51.
PubMed 22270280Fournier M, Stoeckle E, Guyon F, Brouste V, Thomas L, MacGrogan G, Floquet A. Lymph node involvement in epithelial ovarian cancer: sites and risk factors in a series of 355 patients. Int J Gynecol Cancer. 2009 Nov;19(8):1307-13. doi: 10.1111/IGC.0b013e3181b8a07c.
PubMed 20009882Woelber L, Eulenburg C, Choschzick M, Kruell A, Petersen C, Gieseking F, Jaenicke F, Mahner S. Prognostic role of lymph node metastases in vulvar cancer and implications for adjuvant treatment. Int J Gynecol Cancer. 2012 Mar;22(3):503-8. doi: 10.1097/IGC.0b013e31823eed4c.
PubMed 22266935Yang B, Zhu L, Cheng H, Li Q, Zhang Y, Zhao Y. Dosimetric comparison of intensity modulated radiotherapy and three-dimensional conformal radiotherapy in patients with gynecologic malignancies: a systematic review and meta-analysis. Radiat Oncol. 2012 Nov 23;7:197. doi: 10.1186/1748-717X-7-197.
PubMed 23176540Kidd EA, Siegel BA, Dehdashti F, Rader JS, Mutic S, Mutch DG, Powell MA, Grigsby PW. Clinical outcomes of definitive intensity-modulated radiation therapy with fluorodeoxyglucose-positron emission tomography simulation in patients with locally advanced cervical cancer. Int J Radiat Oncol Biol Phys. 2010 Jul 15;77(4):1085-91. doi: 10.1016/j.ijrobp.2009.06.041. Epub 2009 Oct 31.
PubMed 19880262