Clinical trial NCT03268876: The INFLUENCE of Cytoreduction on PRO in EOC
Official title: The INFLUENCE of Cytoreduction on Patient Reported Outcomes in Patients With Epithelial Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Epithelial Ovarian Cancer
Keywords: Epithelial ovarian cancer
Surgery
Quality of life
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: Helse Stavanger HF
name: Sorlandet Hospital HF
First posted: 2017-08-31
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients primary treated with primary surgery for advanced epithelial ovarian cancer at the participating institutions will be asked to participate.

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).

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

Primary outcomes:
measure: Mean Global Health Score
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Kristiansand
country: Norway
facility: Sørlandet sykehus HF
city: Stavanger
country: Norway
facility: Stavanger University Hospital
Study officials:
affiliation: Helse-Bergen HF
name: Line Bjørge, MD, PhD, MBA
role: PRINCIPAL_INVESTIGATOR
References: