The INFLUENCE of Cytoreduction on PRO in EOC

Active, not recruiting

• Conditions: Epithelial Ovarian Cancer

• Registration Number: NCT03268876
• Lead Sponsor: Haukeland University Hospital

Brief Summary

Based on an improved understanding of how the extent of successful cytoreduction is influenced both by inherent tumor biological characteristics as well as the aggressiveness of the surgical approach this project aims to better define the value of cytoreduction and to use the knowledge gained to develop more individualized therapy and follow-up. This will be achieved through a translational biomedical research approach. Due to the research group's traditions clinical phenotyping, biomarker identification, and clinical trials will be the focus.

Detailed Description

The patients will be recruited at their follow-up appointment after their surgery. At this consultation the patient will be informed about the final diagnosis and extent of disease and a plan for their further chemotherapeutic treatment will be developed. All patients will be offered carboplatin AUC 5 and paclitaxel 175mg/m2 q3w for 6 cycles \[+ bevacizumab 7.5mg/kg q3w for 18 cycles in high-risk women of recurrence (IIIc not maximal debulked with a rest tumor of \>1 cm2 and stage IV)\]. In they fulfill the inclusion criteria and agree the inform consent formula will be signed. During the screening period the study team will secure that the necessary information needed is available and study specific test and analysis will be undertaken. After inclusion the study specific consultations will be scheduled coinciding with the patient regular appointments for treatment and follow-up. The patients will be followed at predetermined time points (after finalizing the chemotherapy; and every 3 months thereafter for 2 years).

Study Timeline

• Study First Submitted: 2017-08-29
• Study First Submitted QC: 2017-08-30
• Study First Posted: 2017-08-31
• Study Start: 2021-03-03
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-06
• Last Update Posted: 2024-10-09
• Primary Completion: 2025-12-28
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

• Epithelial ovarian cancer
• Stage > II
• ECOG < II
• Treated with primary surgery followed by chemotherapy
• Willing to participate and to sign the informed consent

Exclusion Criteria

• < 18 years old
• Borderline and non-epithelial ovarian tumors
• Stage < II
• Advanced ovarian cancer submitted to neoadjuvant chemotherapy
• ECOG 3-4
• Pregnancy
• Severe cardiopulmonary disease
• Patients participating in QoL intervention studies

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean Global Health Score	2 years	Is there a relationship between QOL score and immunologic profiling in biological samples?

Trial Locations

Locations (3)

Haukeland University Hospital; 🇳🇴 Bergen, Norway

Sørlandet sykehus HF; 🇳🇴 Kristiansand, Norway

Stavanger University Hospital; 🇳🇴 Stavanger, Norway