Status:
COMPLETED
Short-course HIPEC in Advanced Epithelial Ovarian Cancer
Lead Sponsor:
Professor Fernando Figueira Integral Medicine Institute
Collaborating Sponsors:
Hospital de Câncer de Pernambuco (Recife/PE)
AC Camargo Cancer Center (São Paulo/SP)
Conditions:
Ovarian Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This is an open-label, multicenter, single-arm, feasibility phase 2 trial on safety and efficacy of short-course regimen of intra-operative Hyperthermic Intraperitoneal Chemotherapy (HIPEC) at the tim...
Detailed Description
This study was initially designed to explore the safety and efficacy of short-course HIPEC in terms of median progression-free survival (PFS) as the primary outcome. However, due to slow accrual, the ...
Eligibility Criteria
Inclusion
- Patients with no previous treatment and candidates for elective surgery with histological diagnosis of epithelial ovarian carcinoma;
- Clinical stage IIIB to IV, without suspicion of extra-abdominal metastasis;
- No other malignancies in activity;
- No previous treatments such as radiation, chemotherapy (except neoadjuvant chemotherapy in the study protocol) or major abdominal surgery;
- Absence of neuro-psychiatric disorders, history of drug allergies, and pregnancy or breast feeding;
- Aged between 18 and 70 years;
- Performance status 0-2 (ECOG, Eastern Cooperative Oncology Group) and / or greater than 70 points by the Karnofsky scale;
- Appropriated cardio-respiratory, hepato-renal and hematological reserves;
- Signing of the Consent Form.
Exclusion
- Evidence of extensive retroperitoneal lymph node involvement or unresectable disease (i.e., massive involvement of the small bowel, mesentery, or hepatic pedicle, and ureteral or biliary obstruction) at the time of CRS/HIPEC;
- Residual disease after the CRS greater than or equal to 2.5 mm (CC-2 and CC-3);
- Limiting obesity for CRS or HIPEC;
- Disease progression, apparent or confirmed uncontrolled infection, or health impairment during NACT.
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT02249013
Start Date
February 1 2015
End Date
February 23 2021
Last Update
March 18 2021
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