Timing of Surgery After Neoadjuvant Chemotherapy for Advanced Ovarian Cancer

NCT06404671 | Recruiting

• 1 other identifier: SGOU 1
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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

Keywords

high grade serous; advanced primary ovarian cancer; interval cytoreduction

Outcome Measures

Primary Outcomes (2)

• Progression-free survival (PFS)

  PFS will be defined as the time to recurrence/progression, or the date of death. Disease recurrence/ progression is defined as an increase in cancer antigen 125 (CA 125) levels or evidence of recurrence by imaging and/or histology.

  up to 5years

• Overall survival (OS)

  OS will be defined as the time until the patient's death from any cause. The time to event occurrence will be calculated from the time of randomization until the event of interest.

  up to 5 years

Secondary Outcomes (7)

• Operative peritoneal cancer index (PCI) assessment

  3-6 months

• Complete resection rate

  3-6 months

• Surgical complexity scoring (low, intermediate, or high)

  3-6 months

• Post-operative morbidity

  within 30 days of surgery

• Pathological complete chemotherapy response score (CRS 3)

  3-6 months

Study Arms (2)

delayed interval cytoreduction surgery (DICS)

EXPERIMENTAL

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

Procedure: Delayed interval cytoreductive surgery (DICS)

Early interval cytoreduction surgery (EICS)

ACTIVE COMPARATOR

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

Procedure: Early interval cytoreductive surgery (EICS)

Interventions

Delayed interval cytoreductive surgery (DICS) 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.

delayed interval cytoreduction surgery (DICS)

Early interval cytoreductive surgery (EICS) 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.

Early interval cytoreduction surgery (EICS)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female Patients aged 18 to 75 years.
• International Federation of Gynecology and Obstetrics (FIGO) stage IIIB-IV unsuitable for UCS.
• Histologically confirmed high-grade serous (HGS) ovarian, fallopian tube, or primary peritoneal carcinoma.
• ECOG performance status: 0 or 1.
• Resectable disease by laparoscopic assessment after 3 cycles of NACT.
• Adequate haematology, bone marrow, respiratory, hepatic, cardiac and renal functions.
• 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.

You may not qualify if:

• Metastatic ovarian carcinoma.
• Patients with primary ovarian carcinoma other than high-grade serous (low-grade serous, endometrioid, mucinous, clear cell, and non-epithelial ovarian carcinoma).
• Presence of pregnancy or breast-feeding.
• History of other invasive malignancies in the previous 5 years.
• History of a recent \< 6 month cerebrovascular accident.
• Uncontrolled systemic disease or contraindication to chemotherapy.
• Progressive disease on NACT.
• Worsening Eastern Cooperative Oncology Group (ECOG) Performance Status (ECOG 2-4).
• Severe comorbidities (ACCI \>= 4)

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Elshatby Maternity University Hospital

Alexandria, Egypt

RECRUITING

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

Hayat Sharaf, MsC

CONTACT

00201025774942; h_mohammed14@alexmed.edu.eg

Alaa Elzarkaa, PhD

CONTACT

00201008296264; A_elzarka09@alexmed.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 8, 2024
• Study Start: September 15, 2023
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): March 20, 2029
• Last Updated: May 8, 2024

Record last verified: 2024-01

Locations

EG (1)