The INFLUENCE of Cytoreduction on PRO in EOC

Haukeland University Hospital

Status: Active, not recruiting

Conditions: Epithelial Ovarian Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT03268876

2017/941

Details and patient eligibility

About

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.

Full 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).

Enrollment: 70 estimated patients

Sex: Female

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

70 participants in 1 patient group

Epithelial ovarial cancer

Description:

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