The INFLUENCE of Cytoreduction on PRO in EOC

Epithelial Ovarian Cancer Clinical Trial

— INFLUENCE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03268876
• Other study ID #: 2017/941
• Status: Recruiting
• Start date: March 3, 2021
• Est. completion date: December 31, 2030

Study information

• Verified date: February 2023
• Source: Haukeland University Hospital
• Contact: Line Bjørge, MD, PhD, MBA
• Phone: +4755975000
• Email: line.bjorge[@]uib.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 31, 2030
• Est. primary completion date: February 28, 2024
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Epithelial Ovarian Cancer
• Ovarian Neoplasms

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen
Norway	Sørlandet sykehus HF	Kristiansand
Norway	Stavanger University Hospital	Stavanger

Sponsors (3)

Lead Sponsor	Collaborator
Haukeland University Hospital	Helse Stavanger HF, Sorlandet Hospital HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Global Health Score	Is there a relationship between QOL score and immunologic profiling in biological samples?	2 years