SUROVA - Surgery in Ovarian Cancer, Comparing Primary and Interval Cytoreductive Surgery

Last updated: January 15, 2024
Sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Overall Status: Active - Recruiting

Phase

N/A

Condition

Digestive System Neoplasms

Peritoneal Cancer

Ovarian Cysts

Treatment

Cytoreductive surgery

Adjuvant chemotherapy

Neoadjuvant chemotherapy

Clinical Study ID

NCT06223763
SUROVA
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients > 18 years old.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 at the time of thesurgery.
  • Invasive high-grade epithelial ovarian cancer, fallopian tube carcinoma, or primaryperitoneal carcinoma in stage International Federation of Gynecology and Obstetrics (FIGO) IIIB-IVB (IVB only if resectable metastases are present), suspected orhistologically confirmed and newly diagnosed.
  • Patient underwent primary surgery or first course of neoadjuvant chemotherapy betweenJanuary 1, 2018, and December 31, 2019.
  • American Society of Anesthesiologists Physical Status Classification System (ASA)score 1 or 2 at the time of the surgery.
  • Surgery performed by laparotomy with an attempt of maximal effort.
  • The surgeon must be a certified or non-certified gynecologic oncologist.
  • Based on all available information before the surgery (primary or interval), thepatient was considered completely resectable.
  • Adequate bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L.
  • Preoperative imaging (either CT, whole-body MRI, or positron emission tomography (PET)-CT) excluding unresectable disease as per European Society of GynaecologicalOncology (ESGO) criteria.
  • Surgical report on residual disease after surgery.

Exclusion

Exclusion Criteria:

  • Non-epithelial malignant ovarian neoplasms and borderline tumors.
  • Secondary invasive neoplasms in the last 5 years (except synchronal endometrialcarcinoma FIGO IA G1/2, non melanoma skin cancer, breast cancer T1 N0 M0 G1/2) or withany signs of relapse or activity.
  • Recurrent ovarian cancer.
  • Prior chemotherapy for ovarian cancer or abdominal/pelvic radiotherapy.
  • Unresectable parenchymal lung metastasis, liver metastasis or bulky lymph-nodes in themediastinum in CT chest and abdomen/pelvis before surgery (primary or interval).
  • Pregnant women at the time of diagnosis.

Study Design

Total Participants: 5000
Treatment Group(s): 3
Primary Treatment: Cytoreductive surgery
Phase:
Study Start date:
January 01, 2024
Estimated Completion Date:
June 01, 2024

Study Description

SUROVA study tries to compare the outcomes of primary cytoreductive surgery with neoadjuvant chemotherapy and interval cytoreductive surgery in patients with carcinoma of the ovary, fallopian tubes, and peritoneum operated between 2018 and 2019 worldwide.

The objective is to know if the surgical approach influences our patients' survival (OS and PFS). To answer this question, SUROVA is necessary.

While the prospective Trust Trial, with results expected in 2024, is designed to address this question, a limitation of this study is that it is confined to patients treated in high-end hospitals. This limitation could introduce bias in the results, as many patients may lack access to such high-level healthcare facilities. Therefore, the objective is to extend the scope of this study to real life. To achieve this, the investigators are seeking to collect data from patients treated globally during 2018 and 2019, involving both primary and interval cytoreduction.

The investigators hope that the results of this study will be subjected to evaluation at international meetings and published in reputable international journals. Authorship will be based on a rigorous criterion tied to the number of valid cases included in the study. Naturally, the aim is to include as many authors as possible.

The researchers strongly believe that patients would greatly benefit from SUROVA data and that it will address this critical question and provide invaluable insights.

Connect with a study center

  • Clínica Universidad de Navarra

    Madrid, 28027
    Spain

    Active - Recruiting

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