Trial Title:
Study on the Relative Dose Intensity of PARP Inhibitors in Real-life on a Population of Patients Over 70 Years With Advanced Ovarian Cancer
NCT ID:
NCT06572735
Condition:
Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Conditions: Keywords:
Cancer
ovary
PARP inhibitors
toxicity
elder patients
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
QoL surveys
Description:
2 quality of life surveys (OV28 and ELD14) will be completed by patients every 3 months
during a 12-month period
Arm group label:
Patients with advanced ovarian cancer
Intervention type:
Other
Intervention name:
Geriatric assessment (G-CODE)
Description:
A geriatric assessment (G-CODE) will be performed by the research staff every 3 months
during a 12-month period
Arm group label:
Patients with advanced ovarian cancer
Intervention type:
Biological
Intervention name:
Blood sampling
Description:
A supplementary volume of blood will be collected from a routine blood sample (8 mL) at 3
different time points : one at inclusion, one 6 and 12 months after the beginning of PARP
inhibitors treatment. Genetic lab test will be performed to assess whether there is a
specific genetic signature for PARP inhibitors toxicity.
Arm group label:
Patients with advanced ovarian cancer
Summary:
Poly(ADP-ribose) polymerase (PARP) inhibitors are anti-cancer treatments that induce
preferential tumor cell death. Their efficacy has been demonstrated in many tumor models,
primarily in advanced ovarian cancer. PARP inhibitors also exhibit a particular toxicity,
damaging the hematopoietic tissue. With age, pharmacokinetic changes or a reduction in
medullary cavity may increase these toxicities and may lead to dose
reductions/postponements or premature discontinuation of PARP inhibitors, which may
impact the efficacy of treatment. Close biological monitoring must be carried out to
limit these toxicities, in most cases anemia, thrombocytopenia and neutropenia. Until
now, the geriatric factors impacting the tolerance and uptake of PARP inhibitors in the
elderly patient population with advanced ovarian cancer are not clearly established. It
is therefore necessary to have prospective real-life data in order to support patients in
a decision-making process on whether or not to continue such treatments.
PARIB-OLD-PRO² will evaluate the association between various clinical, biological, and
geriatric factors and the relative dose intensity (RDI) of therapy by PARP inhibitors.
This is a prospective, multicenter longitudinal and non-interventional study and will
involve a population of 50 patients, aged 70 years and elder, with advanced ovarian
cancer who are scheduled to start a therapy with PARP inhibitors for the first time. The
aim of the study is to better understand the effects of PARP inhibitors on a elderly
population, knowledge of the genetic and clinical determinants of PARP inhibitors
toxicity in this specific population and an optimal management of this therapy related
adverse events in order to maintain an RDI.
Criteria for eligibility:
Study pop:
Patients of 70 years and elder with an advanced ovarian cancer who are scheduled to start
a maintenance therapy with PARP inhibitors for the first time. The necessary number of
patients in the study is 50.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Age ≥ 70 years
- Histologically or cytologically confirmed diagnosis of advanced ovarian cancer (FIGO
stage III or IV)
- PARP inhibitors -naive patient who need to initiate maintenance treatment with PARP
inhibitors for the first time (according the the marketing authorization)
- Patient with a life expectancy of more then 3 months
- Informed patient which does not oppose to participate to the study
Exclusion Criteria:
- Prior treatment with PARP inhibitors
- Patient incapable to take oral tablets/capsules
- Participation in a drug trial that does not authorize concurrent participation in
another trials
- Person unable to attend scheduled examinations/appointments as part of routine care
for geographical, social or psychological reasons
- Concomitant cancer or f cancer history (other than those included in the inclusion
criteria) treated and considered cured for less than 2 years. However, patients with
the following pathologies are eligible:
- Basal cell carcinoma or non-invasive cutaneous squamous cell carcinoma
- Stage 1B or less cervical carcinoma
- Non-invasive superficial bladder cancer
Gender:
Female
Minimum age:
70 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Hospitalier Universitaire d'Amiens Picardie Site Sud
Address:
City:
Amiens
Zip:
80054
Country:
France
Contact:
Last name:
Elodie MOREIRA, MD
Phone:
03.22.45.54.99
Phone ext:
+33
Email:
moreira.elodie@chu-amiens.fr
Investigator:
Last name:
Elodie MOREIRA, MD
Email:
Principal Investigator
Facility:
Name:
Centre de lutte contre le cancer Jean Perrin
Address:
City:
Clermont-Ferrand
Zip:
63011
Country:
France
Contact:
Last name:
Elsa KALBACHER, MD
Phone:
04.73.27.80.80
Phone ext:
+33
Email:
Elsa.KALBACHER@clermont.unicancer.fr
Investigator:
Last name:
Elsa KALBACHER, MD
Email:
Principal Investigator
Facility:
Name:
Groupe Hospitalier Public Sud de l'Oise
Address:
City:
Creil
Zip:
60100
Country:
France
Contact:
Last name:
Elisabeth CAROLA, MD
Phone:
03.44.62.67.65
Phone ext:
+33
Email:
Elisabeth.Carola@ghpso.fr
Investigator:
Last name:
Elisabeth CAROLA, MD
Email:
Principal Investigator
Facility:
Name:
Centre Georges François Leclerc
Address:
City:
Dijon
Zip:
21079
Country:
France
Contact:
Last name:
Leïla BENGRINE LEFEVRE, MD
Phone:
03.80.73.75.06
Phone ext:
+33
Email:
lbengrine@cgfl.fr
Investigator:
Last name:
Leïla BENGRINE LEFEVRE, MD
Email:
Principal Investigator
Facility:
Name:
Polyclinique de Blois
Address:
City:
La Chaussée-Saint-Victor
Zip:
41260
Country:
France
Contact:
Last name:
Yann MOTTAZ, MD
Phone:
02.54.90.65.58
Phone ext:
+33
Email:
ymottaz@clinique-blois.com
Investigator:
Last name:
Yann MOTTAZ, MD
Email:
Principal Investigator
Facility:
Name:
Service Hôpital de jour / Oncologie Médicale, Hôpital de la Croix Rousse
Address:
City:
Lyon
Zip:
69004
Country:
France
Contact:
Last name:
Amandine BRUYAS, MD
Phone:
04.78.86.16.28
Phone ext:
+33
Email:
amandine.bruyas@chu-lyon.fr
Investigator:
Last name:
Amandine BRUYAS, MD
Email:
Principal Investigator
Facility:
Name:
Service de Gériatrie, Hôpital Dr Frédéric Dugoujon
Address:
City:
Lyon
Zip:
69317
Country:
France
Contact:
Last name:
Claire FALANDRY, Professor
Phone:
04.72.07.18.15
Phone ext:
+33
Email:
claire.falandry@chu-lyon.fr
Investigator:
Last name:
Claire FALANDRY, Professor
Email:
Principal Investigator
Facility:
Name:
Service Oncologie Médicale, Hôpital Lyon Sud
Address:
City:
Pierre-Bénite
Zip:
69495
Country:
France
Contact:
Last name:
Nathalie BONNIN, MD
Phone:
04.78.86.43.15
Phone ext:
+33
Email:
nathalie.bonnin@chu-lyon.fr
Contact backup:
Last name:
MD
Investigator:
Last name:
Nathalie BONNIN
Email:
Principal Investigator
Facility:
Name:
Institut de Cancérologie et d'Hématologie Universitaire de Saint Etienne
Address:
City:
Saint-Priest-en-Jarez
Zip:
42271
Country:
France
Contact:
Last name:
Pauline CORBAUX, MD
Phone:
04.77.82.29.33
Phone ext:
+33
Email:
pauline.corbaux@chu-st-etienne.fr
Investigator:
Last name:
Pauline CORBAUX, MD
Email:
Principal Investigator
Start date:
November 1, 2024
Completion date:
May 1, 2026
Lead sponsor:
Agency:
Hospices Civils de Lyon
Agency class:
Other
Source:
Hospices Civils de Lyon
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06572735
