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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| delayed interval cytoreduction surgery (DICS) | Experimental | delayed interval cytoreduction surgery after six courses of intravenous carboplatin and paclitaxel every 3 weeks |
|
| Early interval cytoreduction surgery (EICS) | Active Comparator | Early interval cytoreduction surgery after three courses of intravenous carboplatin and paclitaxel every 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Operative peritoneal cancer index (PCI) assessment | pre- and post-operative PCI | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hayat Sharaf, MsC | Contact | 00201025774942 | h_mohammed14@alexmed.edu.eg | |
| Alaa Elzarkaa, PhD | Contact | 00201008296264 | A_elzarka09@alexmed.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elshatby Maternity University Hospital | Recruiting | Alexandria | Egypt |
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| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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|
| 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:
|
|
| 3-6 months |
| Surgical complexity scoring (low, intermediate, or high) | assessment of complexity score of during surgery | 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. | within 30 days of surgery |
| Pathological complete chemotherapy response score (CRS 3) | Pathological complete chemotherapy response score (CRS 3) in the pathology specimen | 3-6 months |
| The total number of chemotherapy cycles administered | The total number of chemotherapy cycles administered (NACT + adjuvant cycles). | 8 months |
| Tumour recurrence and death | Proportion of patients who had recurrence or died in each group. | Up to 5 years |
| D010051 |
| Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |