Comparing two surgical approaches for ovarian cancer treatment
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
This study is testing which surgical method works better for women with ovarian cancer to see if it helps them live longer and stay healthier after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Sex | Female |
| Sponsor | Clinica Universidad de Navarra, Universidad de Navarra Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Madrid) |
| Trial ID | NCT06223763 on ClinicalTrials.gov |
What this trial studies
The SUROVA study is an international retrospective cohort observational study that compares the outcomes of primary cytoreductive surgery with neoadjuvant chemotherapy against interval cytoreductive surgery in patients diagnosed with ovarian, fallopian tube, or peritoneal cancer. It aims to analyze data from patients treated globally between 2018 and 2019 to determine how different surgical approaches influence overall survival and progression-free survival. By including a diverse patient population, the study seeks to provide insights that extend beyond high-end healthcare facilities, addressing potential biases in previous research.
Who should consider this trial
Good fit: Ideal candidates include patients over 18 years old with high-grade epithelial ovarian cancer, fallopian tube carcinoma, or primary peritoneal carcinoma who underwent surgery or neoadjuvant chemotherapy between 2018 and 2019.
Not a fit: Patients with low-grade tumors or those who did not receive surgery or neoadjuvant chemotherapy during the specified timeframe may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the most effective surgical approaches for improving survival rates in ovarian cancer patients.
How similar studies have performed: While the prospective Trust Trial is ongoing and expected to report results in 2024, the SUROVA study aims to build on existing knowledge and address gaps in understanding surgical outcomes in a broader patient population.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Madrid
- Clínica Universidad de Navarra — Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Luis M Chiva, MD, PhD
- Email: lchiva@unav.es
- Phone: 0034682486041
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.