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A multicenter, low-intervention, drug-based study to evaluate the feasibility and safety of a combined regimen of two intraperitoneal chemotherapy modalities (used in routine clinical practice) following interval surgery for the treatment of advanced ovarian cancer. This is an independent research project (free of commercial interests).
Based on the available evidence, an optimized protocol is proposed for the radical approach to primary advanced ovarian cancer with peritoneal dissemination (FIGO III/IV). After optimal interval surgery defined as CRS + HIPEC, bidirectional therapy (BIC) will be evaluated, reproducing the scheme studied by Armstrong 8 with the modifications and recommendations of GEICO (Spanish Ovarian Cancer Research Group) 18. A series of measures are proposed to minimize the risk of complications and toxicity related to intraperitoneal treatment. All of this, with the ultimate objective of maximizing the patient's disease-free survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Following 3 or 4 cycles of systemic neoadjuvant chemotherapy and complete interval CC-0 surgery, pat | Experimental | Following 3 or 4 cycles of systemic neoadjuvant chemotherapy and complete interval CC-0 surgery, patients in the study will receive 4 cycles of 21 days every 3 weeks of the regimen studied by Armstrong 8 and modified by GEICO 18: IV paclitaxel 175 mg /m2 (day 1) + IP cisplatin 100 mg/m2 (day 2) + IP paclitaxel 60 mg/m2 (day 8). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Following 3 or 4 cycles of systemic neoadjuvant chemotherapy and complete interval CC-0 surgery, patients in the study will receive 4 cycles of 21 days every 3 weeks of the regimen studied by Armstron | Drug | Following 3 or 4 cycles of systemic neoadjuvant chemotherapy and complete interval CC-0 surgery, patients in the study will receive 4 cycles of 21 days every 3 weeks of the regimen studied by Armstrong 8 and modified by GEICO 18: IV paclitaxel 175 mg /m2 (day 1) + IP cisplatin 100 mg/m2 (day 2) + IP paclitaxel 60 mg/m2 (day 8). |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free interval | Number of days without disease | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Safety related to the intervention | Number of adverse events reported | Up to 5 years |
| Quality of life of the participants | To evaluate the Quality of Life parameters of patients before surgery, before the start of treatment and after its completion (3 and 6 months). EQ-5D SCALE, 20-centimeter vertical EVA, measured in millimeters, ranging from 0 (worst imaginable health condition) to 100 (best imaginable health condition). |
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Inclusion Criteria:
Exclusion Criteria:
Twenty patients aged between 18 and 75 years, diagnosed with FIGO stage IIIB-IV epithelial ovarian cancer (high-grade serous epithelial carcinoma) and previously treated with systemic neoadjuvant chemotherapy, followed by cytoreduction + HIPEC and postoperative combined systemic and intraperitoneal chemotherapy, will be initially selected.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pedro Cascales Campos, MD | Contact | 968369500 | cascalescirugia@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Pedro Cascales Campos, MD | HCUVA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HCUVA | Recruiting | Murcia | 30120 | Spain |
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Following 3 or 4 cycles of systemic neoadjuvant chemotherapy and complete interval CC-0 surgery, patients in the study will receive 4 cycles of 21 days every 3 weeks of the regimen studied by Armstrong 8 and modified by GEICO 18: IV paclitaxel 175 mg /m2 (day 1) + IP cisplatin 100 mg/m2 (day 2) + IP paclitaxel 60 mg/m2 (day 8).
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| Up to 5 years |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| 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 |
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