Timing of Surgery After Neoadjuvant Chemotherapy for Advanced Ovarian Cancer

NCT ID: NCT06404671

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-15
• Study Completion Date: 2029-03-20

Brief 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).

Conditions

Ovarian Epithelial Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

delayed interval cytoreduction surgery (DICS)

delayed interval cytoreduction surgery after six courses of intravenous carboplatin and paclitaxel every 3 weeks

Group Type: EXPERIMENTAL

Delayed interval cytoreductive surgery (DICS)

Intervention Type: PROCEDURE

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.

Early interval cytoreduction surgery (EICS)

Early interval cytoreduction surgery after three courses of intravenous carboplatin and paclitaxel every 3 weeks

Group Type: ACTIVE_COMPARATOR

Early interval cytoreductive surgery (EICS)

Intervention Type: PROCEDURE

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.

Interventions

Delayed interval cytoreductive surgery (DICS)

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.

Intervention Type: PROCEDURE

Early interval cytoreductive surgery (EICS)

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.

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Elshatby Maternity University Hospital

Alexandria, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Hayat Sharaf, MsC

Role: CONTACT

h_mohammed14@alexmed.edu.eg

00201025774942

Alaa Elzarkaa, PhD

Role: CONTACT

A_elzarka09@alexmed.edu.eg

00201008296264

Facility Contacts

Mervat Elsersy, PhD

Role: primary

mervat.elsersy@alexmed.edu.eg

+20 109 6311548

Other Identifiers

SGOU 1

Identifier Type: -

Identifier Source: org_study_id