An interventional study of Delayed interval cytoreductive surgery (DICS) and Early interval cytoreductive surgery (EICS) in Ovarian Epithelial Cancer, sponsored by Alexandria University. Recruiting at 1 site in Egypt. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-05-08.
Sponsored by Alexandria University · Not applicable, Interventional, and Treatment
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).
1,619 studies on the registry are indexed under Carcinoma, Ovarian Epithelial; 245 are open to participants now.
This study's planned enrollment of 250 is above the median of 48 across 1,196 interventional studies indexed under Carcinoma, Ovarian Epithelial.
Browse Carcinoma, Ovarian Epithelial studies →Alexandria University is the lead sponsor of 586 studies on the registry; 128 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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 after three courses of intravenous carboplatin and paclitaxel every 3 weeks
Procedure: Early interval cytoreductive surgery (EICS)
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.
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.
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.
Time frame: 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.
Time frame: up to 5 years
Operative peritoneal cancer index (PCI) assessment
pre- and post-operative PCI
Time frame: 3-6 months
Complete resection rate
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.
Time frame: 3-6 months
Surgical complexity scoring (low, intermediate, or high)
assessment of complexity score of during surgery
Time frame: 3-6 months
Post-operative morbidity
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.
Time frame: within 30 days of surgery
Pathological complete chemotherapy response score (CRS 3)
Pathological complete chemotherapy response score (CRS 3) in the pathology specimen
Time frame: 3-6 months
The total number of chemotherapy cycles administered
The total number of chemotherapy cycles administered (NACT + adjuvant cycles).
Time frame: 8 months
Tumour recurrence and death
Proportion of patients who had recurrence or died in each group.
Time frame: Up to 5 years
Started Sep 2023 (actual). Primary completion is estimated for Dec 2028, 63 months after the start.
Of 96 non-industry interventional studies with no phase under Carcinoma, Ovarian Epithelial, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 72. This study's planned 63 months is above that.
Counting every sponsor, half of 98 studies reached it within 43 months; a quarter within 20 and three quarters within 72.
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Carcinoma, Ovarian Epithelial →