Timing of Surgery After Neoadjuvant Chemotherapy for Advanced Ovarian Cancer

Not Applicable

Recruiting

• Conditions: Ovarian Epithelial Cancer
• Interventions: Procedure: Delayed interval cytoreductive surgery (DICS); Procedure: Early interval cytoreductive surgery (EICS)

• Registration Number: NCT06404671
• Lead Sponsor: Alexandria University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-15
• Status Verified: 2024-01
• Study First Submitted: 2024-05-01
• Study First Submitted QC: 2024-05-04
• Last Update Submitted: 2024-05-04
• Study First Posted: 2024-05-08
• Last Update Posted: 2024-05-08
• Primary Completion: 2028-12-30
• Study Completion: 2029-03-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 250

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.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
delayed interval cytoreduction surgery (DICS)	Delayed interval cytoreductive surgery (DICS)	delayed interval cytoreduction surgery after six courses of intravenous carboplatin and paclitaxel every 3 weeks
Early interval cytoreduction surgery (EICS)	Early interval cytoreductive surgery (EICS)	Early interval cytoreduction surgery after three courses of intravenous carboplatin and paclitaxel every 3 weeks

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	up to 5years	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.
Overall survival (OS)	up to 5 years	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.

Secondary Outcome Measures

Name	Time	Method
Tumour recurrence and death	Up to 5 years	Proportion of patients who had recurrence or died in each group.
Surgical complexity scoring (low, intermediate, or high)	3-6 months	assessment of complexity score of during surgery
Post-operative morbidity	within 30 days of surgery	Post-operative morbidity according to the Clavien-Dindo classification (CDC), i.e., proportion of severe complications (CDC grade 3-5) within 30 days of surgery.
Operative peritoneal cancer index (PCI) assessment	3-6 months	pre- and post-operative PCI
Complete resection rate	3-6 months	proportion of patients without macroscopically visible disease according to residual (R), patients will have R0 if no macroscopic residual, R1 if the residual is ≤10 mm, and R2 if the residual is \> 10 mm.
Pathological complete chemotherapy response score (CRS 3)	3-6 months	Pathological complete chemotherapy response score (CRS 3) in the pathology specimen
The total number of chemotherapy cycles administered	8 months	The total number of chemotherapy cycles administered (NACT + adjuvant cycles).

Trial Locations

Locations (1)

Elshatby Maternity University Hospital; 🇪🇬 Alexandria, Egypt