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RecruitingNCT06902467BICOVUpdated Mar 30, 2025

Combined Intraperitoneal Chemotherapy Regimen After Optimal Interval Surgery in Advanced Ovarian Cancer: BICOV-1 (Bidirectional Chemotherapy in Ovarian Cancer)

An interventional study of 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 in Ovarian Cancer, sponsored by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia. Recruiting at 1 site in Spain. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-03-30.

Sponsored by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
Female
01

Study summary

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).

Read the detailed description

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.

02

Conditions studied

03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Women aged 18-70 years with a histologically proven diagnosis of FIGO stage IIIB-C/IV epithelial ovarian cancer (high-grade serous epithelial carcinoma)
  • Absence of extraperitoneal disease.
  • Good performance status: Karnofsky score >70 or Performance status \<= 2
  • Adequate liver function, defined as bilirubin \<0.15 times the upper limit of normal (ULN), aspartate aminotransferase and alanine aminotransferase \<= 2.5 times ULN, and alkaline phosphatase \<= 3 times ULN.
  • Adequate renal function, defined as serum creatinine \<= 1.5 times ULN
  • Acceptable bone marrow function, defined as neutrophils >1.5 x 106 L-1, hemoglobin >10 g/dL-1, and platelets >100.0 x 109 L-1
  • Absence of cardiac, pulmonary, hepatic, renal, or neurological disease that contraindicates major surgery.
  • Negative serum and urine pregnancy test results for women of childbearing potential at the screening visit.
  • Administration of neoadjuvant chemotherapy with a total of 3 or 4 systemic cycles.
  • Surgery with complete CC0 cytoreduction without digestive anastomoses.
  • Patients who have signed the written IC.

Exclusion criteria

Exclusion Criteria:

  • Disease progression during systemic treatment with neoadjuvant chemotherapy.
  • Extraperitoneal disease (including retroperitoneal lymph node metastases)
  • Inability to achieve complete cytoreduction (CC-0) during preoperative (imaging) or intraoperative evaluation.
  • Performance of at least one digestive anastomosis of any type. Active infection of any origin
  • Allogeneic transplant, or prior bone marrow transplant, or high-dose chemotherapy with bone marrow or stem cell rescue.
  • Participation in a clinical trial with an investigational drug within the last 30 days.
  • Pregnant or breastfeeding women, where pregnancy is defined as the state of a woman after conception and until the end of pregnancy, confirmed by a positive human chorionic gonadotropin (hCG) test result, or who plan to become pregnant or breastfeed during study treatment or within 30 days of the end of treatment with the study drug.
  • Patients with a history of allergic reactions or hypersensitivity to drugs chemically related to cisplatin and paclitaxel.
  • Failure to sign written informed consent.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Following 3 or 4 cycles of systemic neoadjuvant chemotherapy and complete interval CC-0 surgery, pat

    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).

    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 Armstron

Interventions

  • DrugFollowing 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

    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).

05

What researchers measure

Primary outcomes

  1. Disease-free interval

    Number of days without disease

    Time frame: Up to 5 years

Secondary outcomes

  1. Safety related to the intervention

    Number of adverse events reported

    Time frame: Up to 5 years

  2. 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).

    Time frame: Up to 5 years

06

Study locations

1 of 1 sites recruiting
  • HCUVA
    Murcia, 30120, Spain
    Recruiting
07

Registry details

Key details

Study ID
NCT06902467
Lead sponsor
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Responsible party
Sponsor
First posted
Mar 30, 2025
Start date
Feb 27, 2023
Primary completion
Mar 15, 2026 (estimated)
Completion
Dec 15, 2026 (estimated)
Last update
Mar 30, 2025

Study contacts

Pedro Cascales Campos, MD
Contact
cascalescirugia@gmail.com
968369500
Pedro Cascales Campos, MD
principal investigator · HCUVA

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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