Clinical trial NCT06223763: SUROVA - Surgery in Ovarian Cancer, Comparing Primary and Interval Cytoreductive Surgery
Official title: An International Retrospective Observational Study Comparing Primary Cytoreductive Surgery With Neoadjuvant Chemotherapy and Interval Cytoreductive Surgery in Patients With Carcinoma of the Ovary, Fallopian Tubes and Peritoneum
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Epithelial Ovarian Cancer
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Keywords: surgery
gynecology
gynecological surgery
ovarian cancer
neoadjuvant chemotherapy
interval cytoreductive surgery
cytoreductive surgery
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
Collaborators: name: Asociación de Amigos de la Universidad de Navarra
First posted: 2024-01-25
Enrollment: 5000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive participant sampling of patients with IIIB-IVB ovarian cancer that underwent primary cytoreductive surgery or interval cytoreductive surgery.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Patients \> 18 years old.
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 at the time of the surgery.
* Invasive high-grade epithelial ovarian cancer, fallopian tube carcinoma, or primary peritoneal carcinoma in stage International Federation of Gynecology and Obstetrics (FIGO) IIIB-IVB (IVB only if resectable metastases are present), suspected or histologically confirmed and newly diagnosed.
* Patient underwent primary surgery or first course of neoadjuvant chemotherapy between January 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), the patient 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 Gynaecological Oncology (ESGO) criteria.
* Surgical report on residual disease after surgery.

Exclusion Criteria:

* Non-epithelial malignant ovarian neoplasms and borderline tumors.
* Secondary invasive neoplasms in the last 5 years (except synchronal endometrial carcinoma FIGO IA G1/2, non melanoma skin cancer, breast cancer T1 N0 M0 G1/2) or with any 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 the mediastinum in CT chest and abdomen/pelvis before surgery (primary or interval).
* Pregnant women at the time of diagnosis.

Primary outcomes:
measure: Overall Survival at 5 years
timeFrame: From date of the first treatment (chemotherapy in the case of neoadjuvant chemotherapy and cytoreduction in the case of primary cytoreductive surgery) to death from ovarian cancer or last follow up, assessed at the 5-year mark.
Secondary outcomes:
measure: Progression Free Survival at 5 years
timeFrame: From date of the first treatment (chemotherapy in the case of neoadjuvant chemotherapy and cytoreduction in the case of primary cytoreductive surgery) to death from ovarian cancer or last follow up assessed at the 5-year mark.
measure: Time to first and second subsequent anticancer therapy or death.
timeFrame: From date of the first treatment (chemotherapy in the case of neoadjuvant chemotherapy and cytoreduction in the case of primary cytoreductive surgery) to death from ovarian cancer or last follow up assessed at the 5-year mark.
measure: Information on surgical treatment approaches
timeFrame: Date of last contact up to 5 years
measure: Aletti surgical score
timeFrame: Date of last contact up to 5 years
measure: Surgical complications: requirement of pharmacological treatment; surgical, endoscopic or radiological intervention, life threatening complications or death.
timeFrame: Date of last contact up to 5 years
measure: Breast cancer susceptibility gene (BRCA) influence
timeFrame: Date of last contact up to 5 years
measure: Homologous Recombination Deficiency (HRD) deficiency influence
timeFrame: Date of last contact up to 5 years
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Clínica Universidad de Navarra
Study officials:
affiliation: University of Navarra
name: Luis M Chiva, MD, PhD
role: STUDY_CHAIR
affiliation: University of Navarra
name: Pilar Ordás, PhD student
role: STUDY_CHAIR
References: