Advanced Radiotherapy (ART) in Gynecological Cancer Patients (GYN-ART)

NCT06306170 | Recruiting

• 1 other identifier: GYN-ART
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gynecologic Cancer; Radiotherapy Side Effect; Radiotherapy; Complications; Survivorship; Progression, Disease; Progression, Clinical

Keywords

Gynecologic Cancer; Image Guided Radiotherapy; PET/CT; Intensity Modulated Radiotherapy; Stereotactic Body Radiotherapy; Oligometastases

Outcome Measures

Primary Outcomes (6)

• Local Relapse Free Survival

  local control (on the treated site) of the disease

  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

  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

  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

  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

  From date of radiotherapy end until the date of death from any cause, assessed up to 120 months

• Cancer Specific Survival

  cancer survival

  From date of radiotherapy end until the date of death from disease progression, assessed up to 120 months

Secondary Outcomes (2)

• Acute toxicity

  Up to three months from the start of radiotherapy

• Late toxicity

  From three months after the start of radiotherapy until the end of follow-up or death, assessed up to 120 months

Other Outcomes (2)

• Predictive factors for disease progression and death

  From radiotherapy end to date of local, regional progression, distant failure, or death, assessed up to 120 months

• Radiomic predictive factors for disease progression and death

  From radiotherapy end to the first registered event (disease progression or death), assessed up to 120 months

Study Arms (1)

Gynecologic cancer patients

Gynecologic cancer patients treated with IGRT, IMRT, SBRT (advanced radiotherapy-ART)

Radiation: Image Guided Radiotherapy

Interventions

Image Guided Radiotherapy RADIATION

Patients treated with IGRT, IMRT, SBRT for Gynecological cancer will be evaluated

Also known as: Intensity Modulated Radiotherapy, Stereotactic Body Radiotherapy

Gynecologic cancer patients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Gender Eligibility Details: Gynecologic tumor patients
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Gynecologic cancer patients, \> 18 years old, treated with IGRT, IMRT, SBRT

You may qualify if:

• gynecologic cancer patients
• \>18 years old
• treated with advanced radiotherapy techniques (IGRT, IMRT, SBRT)

You may not qualify if:

• other tumors
• \> 90 years old

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

San Raffaele Scientific Institute

Milan, MI, 20132, Italy

RECRUITING

Related Publications (24)

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• 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.

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• 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.

  PMID: 37337978 RESULT

• 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.

  PMID: 31908301 RESULT

• 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.

  PMID: 26634381 RESULT

• 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.

  PMID: 33470061 RESULT

• 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.

  PMID: 31821973 RESULT

• 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.

  PMID: 22270280 RESULT

• 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.

  PMID: 20009882 RESULT

• 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.

  PMID: 22266935 RESULT

• 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.

  PMID: 23176540 RESULT

• 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.

  PMID: 19880262 RESULT

• Chen CC, Lin JC, Jan JS, Ho SC, Wang L. Definitive intensity-modulated radiation therapy with concurrent chemotherapy for patients with locally advanced cervical cancer. Gynecol Oncol. 2011 Jul;122(1):9-13. doi: 10.1016/j.ygyno.2011.03.034. Epub 2011 Apr 22.

  PMID: 21514629 RESULT

• Jhingran A, Winter K, Portelance L, Miller B, Salehpour M, Gaur R, Souhami L, Small W Jr, Berk L, Gaffney D. A phase II study of intensity modulated radiation therapy to the pelvis for postoperative patients with endometrial carcinoma: radiation therapy oncology group trial 0418. Int J Radiat Oncol Biol Phys. 2012 Sep 1;84(1):e23-8. doi: 10.1016/j.ijrobp.2012.02.044. Epub 2012 Apr 28.

  PMID: 22543211 RESULT

• Jereczek-Fossa BA, Ronchi S, Orecchia R. Is Stereotactic Body Radiotherapy (SBRT) in lymph node oligometastatic patients feasible and effective? Rep Pract Oncol Radiother. 2015 Nov-Dec;20(6):472-83. doi: 10.1016/j.rpor.2014.10.004. Epub 2014 Nov 7.

  PMID: 26696788 RESULT

• Ling DC, Vargo JA, Burton SA, Heron DE, Beriwal S. Salvage Curative-Intent Reirradiation Stereotactic Body Radiation Therapy for Isolated Pelvic and/or Paraortic Recurrences of Gynecologic Malignancies. Pract Radiat Oncol. 2019 Nov;9(6):418-425. doi: 10.1016/j.prro.2019.05.012. Epub 2019 May 28.

  PMID: 31150869 RESULT

• Macchia G, Lazzari R, Colombo N, Laliscia C, Capelli G, D'Agostino GR, Deodato F, Maranzano E, Ippolito E, Ronchi S, Paiar F, Scorsetti M, Cilla S, Ingargiola R, Huscher A, Cerrotta AM, Fodor A, Vicenzi L, Russo D, Borghesi S, Perrucci E, Pignata S, Aristei C, Morganti AG, Scambia G, Valentini V, Jereczek-Fossa BA, Ferrandina G. A Large, Multicenter, Retrospective Study on Efficacy and Safety of Stereotactic Body Radiotherapy (SBRT) in Oligometastatic Ovarian Cancer (MITO RT1 Study): A Collaboration of MITO, AIRO GYN, and MaNGO Groups. Oncologist. 2020 Feb;25(2):e311-e320. doi: 10.1634/theoncologist.2019-0309. Epub 2019 Oct 10.

  PMID: 32043791 RESULT

• Macchia G, Nardangeli A, Laliscia C, Fodor A, Draghini L, Gentile PC, D'Agostino GR, Balcet V, Bonome P, Ferioli M, Autorino R, Vicenzi L, Raguso A, Borghesi S, Ippolito E, Di Cataldo V, Cilla S, Perrucci E, Campitelli M, Gambacorta MA, Deodato F, Scambia G, Ferrandina G. Stereotactic body radiotherapy in oligometastatic cervical cancer (MITO-RT2/RAD study): a collaboration of MITO, AIRO GYN, and MaNGO groups. Int J Gynecol Cancer. 2022 Jun 6;32(6):732-739. doi: 10.1136/ijgc-2021-003237.

  PMID: 35193941 RESULT

• Macchia G, Pezzulla D, Campitelli M, Laliscia C, Fodor A, Bonome P, Draghini L, Ippolito E, De Sanctis V, Ferioli M, Titone F, Balcet V, Di Cataldo V, Russo D, Vicenzi L, Cossa S, Lucci S, Cilla S, Deodato F, Gambacorta MA, Scambia G, Morganti AG, Ferrandina G. Efficacy and Safety of Stereotactic Body Radiation Therapy in Oligometastatic Uterine Cancer (MITO-RT2/RAD): A Large, Real-World Study in Collaboration With Italian Association of Radiation Oncology, Multicenter Italian Trials in Ovarian Cancer, and Mario Negri Gynecologic Oncology Group Groups. Int J Radiat Oncol Biol Phys. 2023 Oct 1;117(2):321-332. doi: 10.1016/j.ijrobp.2023.04.025. Epub 2023 May 6.

  PMID: 37150261 RESULT

• Reshko LB, Baliga S, Crandley EF, Harry Lomas IV, Richardson MK, Spencer K, Bennion N, Mikdachi HE, Irvin W, Kersh CR. Stereotactic body radiation therapy (SBRT) in recurrent, persistent or oligometastatic gynecological cancers. Gynecol Oncol. 2020 Dec;159(3):611-617. doi: 10.1016/j.ygyno.2020.10.001. Epub 2020 Oct 12.

  PMID: 33059914 RESULT

• Grigsby PW, Singh AK, Siegel BA, Dehdashti F, Rader J, Zoberi I. Lymph node control in cervical cancer. Int J Radiat Oncol Biol Phys. 2004 Jul 1;59(3):706-12. doi: 10.1016/j.ijrobp.2003.12.038.

  PMID: 15183474 RESULT

MeSH Terms

Conditions

Radiation Injuries; Disease Progression

Interventions

Radiotherapy, Image-Guided; Radiotherapy, Intensity-Modulated; Radiosurgery

Condition Hierarchy (Ancestors)

Wounds and Injuries; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• andrei Fodor, MD

  IRCCS San Raffaele Scientific Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrei Fodor, MD

CONTACT

+390226437634; fodor.andrei@hsr.it

Nadia G Di Muzio, Prof

CONTACT

+390226437643; dimuzio.nadia@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: March 12, 2024
• Study Start: February 15, 2024
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): February 15, 2029
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: for another 2 years after the closure of the study
• Access Criteria: request from the corresponding author approved by the Lombardy Territorial Ethics Committee

Locations

IT (1)