The INFLUENCE of Cytoreduction on PRO in EOC

NCT ID: NCT03268876

Last Updated: 2024-10-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-03
• Study Completion Date: 2030-12-31

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).

Conditions

Epithelial Ovarian Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Epithelial ovarial cancer

Patients primary treated with primary surgery for advanced epithelial ovarian cancer (\> stage IIa) at the participating institutions will be asked to participate.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Helse Stavanger HF

OTHER_GOV

Sponsor Role: collaborator

Sorlandet Hospital HF

OTHER_GOV

Sponsor Role: collaborator

Haukeland University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Line Bjørge, MD, PhD, MBA

Role: PRINCIPAL_INVESTIGATOR

Helse-Bergen HF

Locations

Haukeland University Hospital

Bergen, , Norway

Sørlandet sykehus HF

Kristiansand, , Norway

Stavanger University Hospital

Stavanger, , Norway

Countries

Norway

Other Identifiers

2017/941

Identifier Type: -

Identifier Source: org_study_id