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TRImodal DEfinitive invasive vagiNal carcinoma Treatment (TRIDENT protocol): how a standardized approach may change prognostic outcomes
  1. Valentina Lancellotta1,
  2. Gabriella Macchia1,
  3. Giorgia Garganese2,
  4. Bruno Fionda1,
  5. Donato Pezzulla3,
  6. Martina De Angeli1,
  7. Rosa Autorino1,
  8. Tiziano Zinicola1,
  9. Benedetta Gui4,
  10. Luca Russo4,
  11. Simona Maria Fragomeni2,
  12. Gabriella Ferrandina2,
  13. Angeles Rovirosa5,6,
  14. Evis Sala4,7,
  15. Giovanni Scambia2,7,
  16. Maria Antonietta Gambacorta1,7 and
  17. Luca Tagliaferri1
    1. 1U.O.C. Radioterapia Oncologica, Dipartimento di Diagnostica per Immagini, Radioterapia Oncologica ed Ematologia, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome, Italy
    2. 2Dipartimento Scienze della Salute della Donna, del Bambino e di Sanità Pubblica, Unità Ginecologia Oncologica, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy
    3. 3Radiation Oncology Unit, Responsible Research Hospital, Campobasso, Italy
    4. 4Department of Bioimaging, Radiation Oncology and Hematology, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy
    5. 5Radiation Oncology Department, Hospital Clínic-Universitat de Barcelona, Barcelona, Spain
    6. 6Fonaments Clínics Department, Universitat de Barcelona, Barcelona, Spain
    7. 7Università Cattolica del Sacro Cuore, Rome, Italy
    1. Correspondence to Dr Valentina Lancellotta, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Lazio, 00168, Italy; valentina.lancellotta{at}


    Objective Vaginal carcinoma is a rare malignancy accounting for 1–2% of all gynecological cancers. Surgery has a limited role, while definitive radiotherapy–chemotherapy followed by interventional radiotherapy is considered a valid alternative. The aim of the TRIDENT (TRImodal DEfinitive invasive vagiNal carcinoma Treatment) pilot study was to report the results of a modern standardized trimodal protocol treatment consisting of image guided definitive radiotherapy–chemotherapy followed by image guided interventional radiotherapy in terms of safety and efficacy.

    Methods Between January 2019 and December 2021, we analyzed 21 consecutive patients with primary vaginal cancer who had received radiotherapy–chemotherapy followed by interventional radiotherapy. The primary study endpoint was local control, and secondary endpoints were metastasis free survival, overall survival, and rate and severity of acute and late toxicities.

    Results 14 patients had FIGO (International Federation of Gynecology and Obstetrics) stage II, five patients had stage III, and two had stage IVB disease. Median total external beam radiotherapy dose for the tumor was 45 Gy. Median total dose on positive nodes was 60 Gy. Median total dose for interventional radiotherapy was 28 Gy over four high dose rate fractions to achieve between 85 and 95 Gy equivalent dose, in 2 Gy fractions (EQD2)α/β10, to the high risk clinical target volume, and 60 Gy EQD2α/β10 to the intermediate risk clinical target volume. All patients received weekly platinum based chemotherapy. Median follow-up was 20 months (range 10–56 months). Two year actuarial local control, metastasis free survival, and overall survival rate were 79.4%, 90.5%, and 79.4%, respectively. In terms of acute toxicity, there were no grade 4 events and only one acute grade (G) 3 toxicity (skin). Only vaginal stenosis (G3) was documented 12 months after therapy due to late toxicity.

    Conclusions In this study, definitive radiotherapy–chemotherapy followed by interventional radiotherapy was a safe and effective treatment modality for primary vaginal cancer.

    • Vagina
    • Neoplasm Recurrence, Local
    • Radiotherapy

    Data availability statement

    Data are available upon reasonable request. All data relevant to the study are included in the article.

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    Data availability statement

    Data are available upon reasonable request. All data relevant to the study are included in the article.

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    • Contributors Conceptualization: VL and GM. Methodology: BF and MDA. Software: DP. Validation: ES, AR, GF, and GG. Formal analysis: BG and LR. Investigation: RA and TZ. Data curation: RA, SMF, and TZ. Writing—original draft preparation: VL and GM. Writing—review and editing: GS, MAG, and LT. Visualization: MAG. Supervision: LT. Guarantor: VL.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial, or not-for-profit sectors.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.