Actively Recruiting
Combined Intraperitoneal Chemotherapy Regimen After Optimal Interval Surgery in Advanced Ovarian Cancer: BICOV-1 (Bidirectional Chemotherapy in Ovarian Cancer)
Led by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia · Updated on 2025-03-30
20
Participants Needed
1
Research Sites
198 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Combined Intraperitoneal Chemotherapy Regimen After Optimal Interval Surgery in Advanced Ovarian Cancer: BICOV-1 (Bidirectional Chemotherapy in Ovarian Cancer)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 70 years with histologically confirmed FIGO stage IIIB-C/IV high-grade serous epithelial ovarian cancer
- No evidence of disease outside the peritoneal cavity
- Good performance status: Karnofsky score above 70 or Performance status 2 or less
- Adequate liver function: bilirubin less than 0.15 times ULN, AST and ALT 2.5 times or less ULN, alkaline phosphatase 3 times or less ULN
- Adequate kidney function: serum creatinine 1.5 times or less ULN
- Acceptable bone marrow function: neutrophils above 1.5 x 10^6/L, hemoglobin above 10 g/dL, platelets above 100 x 10^9/L
- No cardiac, lung, liver, kidney, or neurological conditions preventing major surgery
- Negative pregnancy test for women who can become pregnant
- Completed 3 or 4 cycles of systemic neoadjuvant chemotherapy
- Underwent complete CC-0 cytoreductive surgery without digestive anastomoses
- Signed written informed consent
You will not qualify if you...
- Disease progression during neoadjuvant chemotherapy
- Disease outside the peritoneal cavity, including retroperitoneal lymph node metastases
- Inability to achieve complete tumor removal (CC-0) based on imaging or surgery
- Any digestive anastomosis performed
- Active infection of any kind
- Previous allogeneic or bone marrow transplant, or high-dose chemotherapy with marrow or stem cell rescue
- Participation in another clinical trial with investigational drugs within the last 30 days
- Pregnant or breastfeeding women, or planning pregnancy or breastfeeding during or within 30 days after treatment
- History of allergic reactions to drugs related to cisplatin or paclitaxel
- Failure to sign informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
HCUVA
Murcia, Spain, 30120
Actively Recruiting
Research Team
P
Pedro Cascales Campos, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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