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The INFLUENCE of Cytoreduction on PRO in EOC

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03268876
Acronym
INFLUENCE
Enrollment
70
Registered
2017-08-31
Start date
2021-03-03
Completion date
2030-12-31
Last updated
2024-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epithelial Ovarian Cancer

Keywords

Epithelial ovarian cancer, Surgery, Quality of life

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).

Interventions

None listed

Sponsors

Helse Stavanger HF
CollaboratorOTHER_GOV
Sorlandet Hospital HF
CollaboratorOTHER_GOV
Haukeland University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 100 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Mean Global Health Score2 yearsIs there a relationship between QOL score and immunologic profiling in biological samples?

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026