The INFLUENCE of Cytoreduction on PRO in EOC

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Epithelial Ovarian Cancer Adnexal Diseases Carcinoma Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–100 year

Sex eligibility

Female

Study type

Observational

Primary location

Haukeland University Hospital, Bergen, Norway

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Mean Global Health Score

Time frame: 2 years

Is there a relationship between QOL score and immunologic profiling in biological samples?

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Collaborators

Helse Stavanger HF
Sorlandet Hospital HF

Registry information

Official study title

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

Acronym: INFLUENCE

Important dates

Study start: 2021
Primary completion: 2025
Study completion: 2030
First posted: Aug 31, 2017
Registry last updated: Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting