SUROVA - Surgery in Ovarian Cancer, Comparing Primary and Interval Cytoreductive Surgery (NCT06223763) | Clinical Trial Compass
UnknownNot Applicable
SUROVA - Surgery in Ovarian Cancer, Comparing Primary and Interval Cytoreductive Surgery
Spain5,000 participantsStarted 2024-01-01
Plain-language 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.
Who can participate
SexFEMALE
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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 sk…
What they're measuring
1
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.
Trial details
NCT IDNCT06223763
SponsorClinica Universidad de Navarra, Universidad de Navarra