Timing of Surgery After Neoadjuvant Chemotherapy for Advanced Ovarian Cancer

Launched by ALEXANDRIA UNIVERSITY · May 4, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at the best timing for surgery after patients receive neoadjuvant chemotherapy (NACT) for advanced ovarian cancer. Ovarian cancer can be serious, and many women are diagnosed when their cancer is already advanced. Some patients cannot have surgery right away, so they first receive chemotherapy to shrink the tumor. The trial compares the outcomes of patients who have surgery after 3 cycles of chemotherapy versus those who wait until after 6 cycles. The goal is to see which timing leads to better survival rates.

To be eligible for this trial, participants must be women aged 18 to 75 with a specific type of ovarian cancer that is high-grade serous and at an advanced stage. They must also be able to undergo surgery after their chemotherapy. Patients who join the trial will receive the standard chemotherapy and, depending on their assigned group, will have surgery either after 3 or 6 cycles of treatment. It's important to know that this trial is currently recruiting participants, and it aims to help improve treatment options for women facing this challenging diagnosis.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Female Patients aged 18 to 75 years.
• • 2. International Federation of Gynecology and Obstetrics (FIGO) stage IIIB-IV unsuitable for UCS.
• • 3. Histologically confirmed high-grade serous (HGS) ovarian, fallopian tube, or primary peritoneal carcinoma.
• • 4. ECOG performance status: 0 or 1.
• • 5. Resectable disease by laparoscopic assessment after 3 cycles of NACT.
• • 6. Adequate haematology, bone marrow, respiratory, hepatic, cardiac and renal functions.
• • 7. Estimated life expectancy of \> 3 months according to Age-adjusted Charlston Co-morbidity Index (ACCI), included patients should have a low or intermediate comorbidity score; ACCI 0-3.
• Exclusion Criteria:
• • 1. Metastatic ovarian carcinoma.
• • 2. Patients with primary ovarian carcinoma other than high-grade serous (low-grade serous, endometrioid, mucinous, clear cell, and non-epithelial ovarian carcinoma).
• • 3. Presence of pregnancy or breast-feeding.
• • 4. History of other invasive malignancies in the previous 5 years.
• • 5. History of a recent \< 6 month cerebrovascular accident.
• • 6. Uncontrolled systemic disease or contraindication to chemotherapy.
• • 7. Progressive disease on NACT.
• • 8. Worsening Eastern Cooperative Oncology Group (ECOG) Performance Status (ECOG 2-4).
• • 9. Severe comorbidities (ACCI \>= 4)