The INFLUENCE of Cytoreduction on PRO in EOC (INFLUENCE)

The INFLUENCE of Cytoreduction on Patient Reported Outcomes in Patients With Epithelial Ovarian Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Epithelial Ovarian Cancer

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 Type: Observational
• Enrollment (Anticipated): 70

Contacts and Locations

• Study Contact: Name: Line Bjørge, MD, PhD, MBA; Phone Number: +4755975000; Email: line.bjorge@uib.no
• Study Contact Backup: Name: Grete Iversen, MD; Phone Number: +4755975000; Email: gaiv@helse-bergen.no

Study Locations

• Norway
  • Bergen, Norway, 5021
    • Recruiting
    • Haukeland University Hospital
    • Contact: Line Bjørge, MD, PhD; Phone Number: +4755975000
  • Kristiansand, Norway
    • Not yet recruiting
    • Sørlandet Sykehus HF
  • Stavanger, Norway
    • Not yet recruiting
    • Stavanger University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Global Health Score	Is there a relationship between QOL score and immunologic profiling in biological samples?	2 years

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Collaborators: Helse Stavanger HF; Sorlandet Hospital HF
• Investigators: Principal Investigator: Line Bjørge, MD, PhD, MBA, Helse-Bergen HF

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2021
• Primary Completion (Anticipated): February 28, 2024
• Study Completion (Anticipated): December 31, 2030

Study Registration Dates

• First Submitted: August 29, 2017
• First Submitted That Met QC Criteria: August 30, 2017
• First Posted (Actual): August 31, 2017

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Surgery; Quality of life; Epithelial ovarian cancer
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
• Other Study ID Numbers: 2017/941

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No