Status:
RECRUITING
PROADAPT-ovary/EWOC-2
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Ovarian Cancer
Surgery
Eligibility:
FEMALE
70+ years
Phase:
NA
Brief Summary
PROADAPT is a standardized geriatric intervention that is currently being co-constructed during an exploratory phase on a multi-professional and multi-disciplinary basis after a systematic analysis of...
Detailed Description
With the conjunction of increased life expectancy and the increasing incidence of cancer with aging, older patient represent an increasing proportion of cancer patients. Increasing age is also associa...
Eligibility Criteria
Inclusion
- Woman ≥70 year old OR Woman ≥60 years with significant comorbid condition (modified Charlson index≥3) or disability (ADL score\<6/6);
- Histologically or cytologically proven FIGO (International Federation of Gynecology and Obstetrics) stage III to IV epithelial ovarian cancer or peritoneal primary or fallopian tube. A cytological proof is accepted if associated with a ratio of CA125/CEA \>25 and a radiological pelvic mass.
- Patient oriented towards a complex medical procedure defined by pelvic surgery preceded or not by antineoplastic treatment (neoadjuvant chemotherapy).
- Therapeutic decision validated in a multidisciplinary consultation meeting
- Life expectancy \> 3 months.
- Written informed consent obtained.
- Covered by a Health System where applicable.
Exclusion
- Any other progressive malignant tumor interfering with the patient's prognosis.
- Patient whose validated therapeutic management does not include cytoreductive surgery.
- Patient unable to be regularly followed up for any reason (geographic, family, social, psychological).
- Patient unable to understand the questionnaires.
- Patient unable to follow and adhere to test procedures for geographic, social or psychological reasons.
- Patient placed under guardianship or curatorship.
- Patient deprived of liberty.
- Concurrent participation in another interventional drug trial.
- Patient already included in this study
Key Trial Info
Start Date :
June 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 3 2029
Estimated Enrollment :
292 Patients enrolled
Trial Details
Trial ID
NCT04284969
Start Date
June 3 2021
End Date
March 3 2029
Last Update
December 4 2025
Active Locations (11)
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1
Chu Bordeaux Pellegrin
Bordeaux, France, 33000
2
CH Métropole Savoie
Chambéry, France, 73000
3
Centre Georges François Leclerc
Dijon, France, 21079
4
Hôpital Croix Rousse
Lyon, France, 69004