AI Article Synopsis
- A debate is ongoing among medical professionals about the best treatment methods for advanced ovarian cancer (stages IIIB-IVB), focusing on primary cytoreductive surgery vs. neoadjuvant chemotherapy followed by cytoreductive surgery.
- The study aims to compare the 5-year survival rates of patients who receive either treatment, hypothesizing that primary cytoreductive surgery leads to better survival outcomes.
- This multicenter retrospective study will include approximately 5,000 patients and is expected to reach its conclusion by March 2025, with survival rates as the main focus.
Article Abstract
Background: Currently, a lively debate exists within the scientific community regarding the most suitable procedure for treating stages IIIB-IVB carcinoma of the ovary, fallopian tubes, and peritoneum. The options under most consideration are primary cytoreductive surgery or neoadjuvant chemotherapy followed by interval cytoreductive surgery.
Primary Objective: To compare overall survival at 5 years in patients who underwent primary cytoreductive surgery versus neoadjuvant chemotherapy and interval cytoreductive surgery for stage IIIB-IVB ovarian cancer STUDY HYPOTHESIS: The treatment with primary cytoreductive surgery results in superior patient survival compared with neoadjuvant chemotherapy followed by interval cytoreductive surgery.
Trial Design: This is a multicenter, retrospective cohort observational study. Data will be collected from patients undergoing surgery in hospitals worldwide. Two arms will be compared: primary cytoreductive surgery and neoadjuvant chemotherapy followed by interval cytoreductive surgery.
Major Inclusion/exclusion Criteria: Patients must have suspected or histologically confirmed International Federation of Gynecology and Obstetrics (FIGO) stages IIIB-IVB ovarian, peritoneal, or fallopian tube cancers. They must have undergone primary surgery or first course of neoadjuvant chemotherapy between January 1, 2018 and December 31, 2019. Based on all available information before the surgery (primary or interval), the patient must have been considered completely resectable.
Primary Endpoint: Overall survival at 5 years from the first treatment (chemotherapy in the case of neoadjuvant chemotherapy and cytoreduction in the case of primary cytoreductive surgery).
Sample Size: An estimated total of 5000 patients will be enrolled in the study.
Estimated Dates For Completing Accrual And Presenting Results: March 2025 TRIAL REGISTRATION: NCT06223763.
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Source |
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| http://dx.doi.org/10.1136/ijgc-2024-005354 | DOI Listing |
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