NCT05810701: FRAGINOC

FRAGINOC Study: Screening and Geriatric Assessment and Intervention in Older Patients With Epithelial Ovarian Cancer

Recruiting now NA Last updated 12 April 2023

What this trial tests

NA trial testing Comprehensive geriatric assessment and individualised physical training in Ovarian Cancer in 300 participants. Currently enrolling.

Timeline

1 February 2023

Primary endpoint
1 February 2026

31 December 2027

Quick facts

Lead sponsor	Odense University Hospital
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	300
Start date	1 February 2023
Primary completion	1 February 2026
Estimated completion	31 December 2027
Sites	5 locations across Denmark

Drugs / interventions tested

• Comprehensive geriatric assessment and individualised physical training

Conditions studied

• Ovarian Cancer — all drugs for Ovarian Cancer →
• Frailty — all drugs for Frailty →

Sponsor

Odense University Hospital

Who can join

Adults 70 to 120, female only, with Ovarian Cancer or Frailty. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Ovarian cancer (OC) is the fifth most common cause of cancer death. More than 40% are older than 70 years. The standard treatment is radical surgery combined with chemotherapy. More than 40% of the Danish patients will never undergo surgery. Frail and immunodeficient older patients are at higher risk of complications, and immunomodulating treatment as chemotherapy results in different outcomes in comparable patients. No accurate validated screening tool to identify frail and immunodeficient OC women exists. Optimization through comprehensive geriatric assessment (CGA) and physical training before and during treatment may improve outcomes and decrease associated risks.

Aim: Primary endpoints will be to determine whether a CGA and physical training vs standard of care can increase the proportion of patients later on referred to interval debulking surgery, and examine the performance of validated screening tests in predicting impairments in CGA. Other endpoints will be to evaluate if intervention can improve completion of chemotherapy, to examine the association between frailty screening scores and selected biomarkers with treatment outcomes, including complications and quality of life, and ultimately to develop an improved frailty screening tool based on known screening tools, functional tests and biomarkers identifying patients who will benefit from CGA.

Method: This is a nationwide, randomized intervention study. Patients ≥70 years diagnosed with primary OC at the Gynecological departments of Rigshospitalet, Odense and Roskilde University Hospitals will be included. In an interdisciplinary collaboration between medical specialists in oncology, gynecology and geriatrics, included patients will be screened for frailty using validated screening tools and functional tests. Specific biomarkers and immunologic profile will be assessed in all patients. Patients selected for neoadjuvant chemotherapy will be randomized to receive CGA or standard of care. Patients selected for primary debulking surgery or palliation will be followed in an observational cohort.

Perspective: The development of a validated screening tool for frailty assessment and immunological status will help us identify frail patients who may need optimization before treatment, resulting in more patients getting optimal treatment (either surgery or chemotherapy), prevent post-treatment complications and avoid palliative patients from undergoing a redundant complex treatment.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Future theranostic strategies: emerging ovarian cancer biomarkers to bridge the gap between diagnosis and treatment.
   Rajapaksha W, Khetan R, Johnson IRD, Blencowe A, et al · · 2024 · cited 6× · PMID 40836974 · DOI 10.3389/fddev.2024.1339936