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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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
Are there results?
Not yet: the study is under way

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.

Andrei Fodor, MD contact

+390226437634

fodor.andrei@hsr.it

Nadia G Di Muzio, Prof contact

+390226437643

dimuzio.nadia@hsr.it

Italy1 site, 1 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

    Recruiting

Other trials in Italy

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.

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 groups in NCT06306170
Study groupRoleWhat they receive
Gynecologic cancer patientsGynecologic 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.

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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)

  1. 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

  2. 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.

  1. First posted12 Mar 2024
  2. Study start15 Feb 2024
  3. Primary completion15 Feb 2027 (estimated)
  4. Study completion15 Feb 2029 (estimated)

Resources

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)
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 36759096

  • Stewart 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 30867104

  • Siegel 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 35020204

  • Sung 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 33538338

  • Makker 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 34887451

  • Berek 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 37337978

  • Guckenberger 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 31908301

  • Colombo 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 26634381

  • Tortorella 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 33470061

  • Ramanathan 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 31821973

  • Milam 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 22270280

  • Fournier 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 20009882

  • Woelber 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 22266935

  • Yang 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 23176540

  • Kidd 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

Questions about this trial

What is this clinical trial studying?

An observational study of Gynecologic Cancer and Radiotherapy Side Effect, run by IRCCS San Raffaele at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Andrei Fodor, MD (+390226437634, fodor.andrei@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Local Relapse Free Survival (time frame: 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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06306170, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.

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