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

Launched by CLINICA UNIVERSIDAD DE NAVARRA, UNIVERSIDAD DE NAVARRA · Jan 15, 2024

Keywords

ClinConnect Summary

The SUROVA trial is a study looking at different treatment approaches for women with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. Specifically, it compares primary cytoreductive surgery (surgery done first to remove as much cancer as possible) with interval cytoreductive surgery (surgery done after initial chemotherapy). The goal is to see which approach leads to better outcomes for patients.

To be eligible for this trial, participants must be women over 18 years old diagnosed with high-grade epithelial ovarian cancer at an advanced stage. They should be in good health overall, as indicated by specific performance status scores. Participants will undergo either surgery or chemotherapy as part of their treatment plan. This trial is currently recruiting patients, and those who join can expect to have their health monitored closely throughout the process. It’s important to note that only certain types of ovarian cancer are included, and those with other types or previous cancers may not qualify.

Gender

FEMALE

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.