Timing of Surgery After Neoadjuvant Chemotherapy for Advanced Ovarian Cancer

Trial Title: Timing of Surgery After Neoadjuvant Chemotherapy for Advanced Ovarian Cancer

NCT ID: NCT06404671

Condition: Ovarian Epithelial Cancer

Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial

Conditions: Keywords:
high grade serous
advanced primary ovarian cancer
interval cytoreduction

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Delayed interval cytoreductive surgery (DICS)
Description: patients will receive six courses of intravenous carboplatin and paclitaxel every 3 weeks, followed by delayed interval cytoreductive surgery (DICS) within 6 weeks of the last cycle of chemotherapy. After DICS, patients will be assessed for the need or not for further adjuvant chemotherapy. chemotherapy regimen: - Paclitaxel at 175 mg/m² + carboplatin area under the curve (AUC) 5-6 every 3 weeks. - Paclitaxel at 60 mg/m² (days 1, 8, and 15), and carboplatin AUC 2 (days 1, 8, and 15) every 3 weeks. - Paclitaxel at dense dose 80 mg/m² (days 1, 8, and 15) and carboplatin AUC 5-6 (day 1) every 3 weeks.
Arm group label: delayed interval cytoreduction surgery (DICS)

Intervention type: Procedure
Intervention name: Early interval cytoreductive surgery (EICS)
Description: patients will receive three courses of intravenous carboplatin and paclitaxel every 3 weeks, followed by early interval cytoreductive surgery (EICS) within 6 weeks of the last cycle of chemotherapy. After EICS, patients will receive adjuvant three courses of intravenous carboplatin and paclitaxel every 3 weeks, then will be assessed for the need or not for further adjuvant chemotherapy. chemotherapy regimen: - Paclitaxel at 175 mg/m² + carboplatin area under the curve (AUC) 5-6 every 3 weeks. - Paclitaxel at 60 mg/m² (days 1, 8, and 15), and carboplatin AUC 2 (days 1, 8, and 15) every 3 weeks. - Paclitaxel at dense dose 80 mg/m² (days 1, 8, and 15) and carboplatin AUC 5-6 (day 1) every 3 weeks.
Arm group label: Early interval cytoreduction surgery (EICS)

Summary: Ovarian cancer is among the top five primary causes of cancer-related mortality in women. Most ovarian malignant tumours originate from epithelial cells The majority of patients typically have advanced-stage tumours at diagnosis. When complete surgery with no macroscopic visible disease is not feasible due to both the spread of the disease and the patient's general condition, neoadjuvant chemotherapy (NACT) of 3 cycles followed by interval cytoreductive surgery (ICS) or final cytoreductive surgery (FCS) after 6 cycles of NACT followed or not by adjuvant chemotherapy can be offered, with similar overall survival. In our centre, due to logistics, disease, or patient factors, many patients may receive more than 3 cycles of NACT before ICS. Therefore, this randomized controlled trial aims to evaluate the survival benefit of different timings of ICS after 3 or 6 cycles of NACT in patients not eligible for upfront cytoreductive surgery (UCS).

Criteria for 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)

Gender: Female

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Elshatby Maternity University Hospital

Address:
City: Alexandria
Country: Egypt

Status: Recruiting

Contact:
Last name: Mervat Elsersy, PhD

Phone: +20 109 6311548
Email: mervat.elsersy@alexmed.edu.eg

Start date: September 15, 2023

Completion date: March 20, 2029

Lead sponsor:
Agency: Alexandria University
Agency class: Other

Source: Alexandria University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06404671