Clinical trial NCT06404671: Timing of Surgery After Neoadjuvant Chemotherapy for Advanced Ovarian Cancer
Official title: Timing of Surgery After Neoadjuvant Chemotherapy for Advanced Ovarian Cancer: A Randomized Clinical Trial for Early Versus Delayed Interval Cytoreductive Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ovarian Epithelial Cancer
Keywords: high grade serous
advanced primary ovarian cancer
interval cytoreduction
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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)

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: up to 5years
measure: Overall survival (OS)
timeFrame: up to 5 years
Secondary outcomes:
measure: Operative peritoneal cancer index (PCI) assessment
timeFrame: 3-6 months
measure: Complete resection rate
timeFrame: 3-6 months
measure: Surgical complexity scoring (low, intermediate, or high)
timeFrame: 3-6 months
measure: Post-operative morbidity
timeFrame: within 30 days of surgery
measure: Pathological complete chemotherapy response score (CRS 3)
timeFrame: 3-6 months
measure: The total number of chemotherapy cycles administered
timeFrame: 8 months
measure: Tumour recurrence and death
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Elshatby Maternity University Hospital
Study officials:
References: