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

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-06-01

Contact for this trial

Luis M Chiva, MD, PhD

0034682486041 lchiva@unav.es

View on ClinicalTrials.gov More Epithelial Ovarian Cancer trials

Who can participate

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.