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Clinical trial
An international worldwide retrospective cohort observational study comparing primary cytoreductive surgery with neoadjuvant chemotherapy and interval cytoreductive surgery in patients with carcinoma of the ovary, fallopian tubes, and peritoneum (SUROVA trial)
  1. Luis Chiva1,
  2. Pilar Ordás2,
  3. Nerea Martin-Calvo3,
  4. Jose Manuel Aramendia4,
  5. Luisa Sanchez Lorenzo5,
  6. Alejandro Gallego Martínez6,
  7. Ángel Vizcay7,
  8. Jose Angel Minguez8,
  9. Nabil Manzour7,
  10. Daniel Vázquez-Vicente9,
  11. Enrique Chacon10,
  12. Teresa Castellanos11 and
  13. Antonio Gonzalez Martin12
    1. 1Clinica Universidad de Navarra Departamento de Ginecologia y Obstetricia, Pamplona, Spain
    2. 2Departamento de Ginecología y Obstetricia, Clínica Universidad de Navarra, Madrid, Navarre, Spain
    3. 3Department of Preventive Medicine and Public Health, Universidad de Navarra, Pamplona, Spain
    4. 4Oncology, Clinica Universitaria de Navarra, Pamplona, Navarra, Spain
    5. 5Oncología Médica, Clínica Universidad de Navarra, Madrid, Madrid, Spain
    6. 6Medical Oncología, Universidad de Navarra, Pamplona, Spain
    7. 7Departamento de Ginecología y Obstetricia, Clinica Universidad de Navarra, Pamplona, Navarre, Spain
    8. 8Gynecology, Clinica Universitaria de Navarra, Pamplona, Navarra, Spain
    9. 9Gynecology, Clinica Universitaria de Navarra, Madrid, Spain
    10. 10Gynecologic Oncology, Universidad de Navarra, Pamplona, Navarra, Spain
    11. 11Gynecology, Clinica Universidad de Navarra, Madrid, Madrid, Spain
    12. 12Medical Oncology, Clinica Universidad de Navarra, Madrid, Madrid, Spain
    1. Correspondence to Dr Luis Chiva, Clinica Universidad de Navarra Departamento de Ginecologia y Obstetricia, Pamplona, Spain; lchiva{at}unav.es

    Abstract

    Background Currently, a lively debate exists within the scientific community regarding the most suitable procedure for treating stages IIIB–IVB carcinoma of the ovary, fallopian tubes, and peritoneum. The options under most consideration are primary cytoreductive surgery or neoadjuvant chemotherapy followed by interval cytoreductive surgery.

    Primary Objective To compare overall survival at 5 years in patients who underwent primary cytoreductive surgery versus neoadjuvant chemotherapy and interval cytoreductive surgery for stage IIIB–IVB ovarian cancer

    Study Hypothesis The treatment with primary cytoreductive surgery results in superior patient survival compared with neoadjuvant chemotherapy followed by interval cytoreductive surgery.

    Trial Design This is a multicenter, retrospective cohort observational study. Data will be collected from patients undergoing surgery in hospitals worldwide. Two arms will be compared: primary cytoreductive surgery and neoadjuvant chemotherapy followed by interval cytoreductive surgery.

    Major Inclusion/Exclusion Criteria Patients must have suspected or histologically confirmed International Federation of Gynecology and Obstetrics (FIGO) stages IIIB–IVB ovarian, peritoneal, or fallopian tube cancers. They must have undergone primary surgery or first course of neoadjuvant chemotherapy between January 1, 2018 and December 31, 2019. Based on all available information before the surgery (primary or interval), the patient must have been considered completely resectable.

    Primary Endpoint Overall survival at 5 years from the first treatment (chemotherapy in the case of neoadjuvant chemotherapy and cytoreduction in the case of primary cytoreductive surgery).

    Sample Size An estimated total of 5000 patients will be enrolled in the study.

    Estimated Dates for Completing Accrual and Presenting Results March 2025

    Trial Registration NCT06223763

    • Surgery
    • Ovarian Cancer
    • Cytoreduction surgical procedures
    • Carcinoma, Ovarian Epithelial
    • Surgical Oncology

    Data availability statement

    Data may be obtained from a third party and are not publicly available.

    https://doi.org/10.1136/ijgc-2024-005354

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      Data availability statement

      Data may be obtained from a third party and are not publicly available.

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      Footnotes

      • Twitter @lchiv4@, @Quique_ChC

      • Collaborators SUROVA study group.

      • Contributors LC and PO have designed and written the manuscript and all the authors have collaborated in the design and development of the trial. LC is acting as guarantor.

      • 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 Commissioned; internally peer reviewed.

      • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.