Ovarian CancerNCT04284969
PROADAPT-ovary/EWOC-2
A study testing PROADAPT program in people with Ovarian Cancer and Surgery, run by Hospices Civils de Lyon at 11 sites in France.
Trial 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 published data (Figure). Read more about this study
- Who is it for?
- Ages 70 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Surgery
- What is being tested?
- PROADAPT program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 11 sitesFrance
- Study dates
- 3 Jun 2021to 3 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Patient deprived of liberty.
- Concurrent participation in another interventional drug trial.
- Patient already included in this study
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Noual BAKRIN, MD contact
11 sites in 1 country
France11 sites, 10 recruiting
- Completed
Chu Bordeaux Pellegrin
Bordeaux, 33000
- Recruiting
CH Métropole Savoie
Chambéry, 73000
Nathalie MARQUES, caroline.deyrolle@ch-chambery.fr
- Recruiting
Centre Georges François Leclerc
Dijon, 21079
Leïla BENGRINE-LEFEVRE, lbengrine@cgfl.fr
- Recruiting
Hôpital Croix Rousse
Lyon, 69004
Emilie NGUYEN-BA, emilie.nguyen-ba@chu-lyon.fr
- Recruiting
Service de Gériatrie, Centre Hospitalier Lyon Sud, 165 chemin du Grand Revoyet
Pierre-Bénite, 69495
Claire FALANDRY, PR, 4.78.86.32.87 ext. +33, claire.falandry@chu-lyon.fr
Noual BAKRIN, MD, naoual.bakrin@chu-lyon.fr
- Recruiting
Centre hospitalier Annecy Genevois
Pringy, 74374
Laetitia STEFANI, lstefani@ch-annecygenevois.fr
- Recruiting
CHU de St Etienne - Service gynécologie
Saint-Priest-en-Jarez, 42270
CHAULEUR, Céline, celine.chauleur@chu-st-etienne.fr
- Recruiting
CHU Nord Saint Etienne - Service oncologie médicale
Saint-Priest-en-Jarez, 42270
- Recruiting
Institut Gustave Roussy
Villejuif, 94805
FRELAUT, Maxime, maxime.frelaut@gustaveroussy.fr
- Recruiting
Médipôle Hôpital Mutualiste
Villeurbanne, 69616
Marie BEGUINOT, m.beguinot@resamut.fr
- Recruiting
Villeurbanne Médipole MHP
Villeurbanne, 69616
Jean-Sébastien KRAUTH, Jskrauth@hyneco-lyonvilleurbanne.fr
About this study
Official title: Prehabilitation & Rehabilitation in Oncogeriatrics: Adaptation to Deconditioning Risk and Accompaniment of Patients' Trajectories-ovary/Elderly Women With Ovarian Cancer-2, a GINECO Multicenter Randomized Study (PROADAPT-ovary/EWOC-2)
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 published data (Figure).
It consists in: 1) before surgery: a prehabilitation of the patients including a nutritional, physical and educational preparation; 2) during the hospitalization for surgery: an optimisation of their treatments through a pharmaceutical conciliation, educational interventions, standardization of surgical procedures and enhanced rehabilitation after surgery; 3) bridging and post-discharge interventions for hospital-to-home transition.
Read more
This intervention is based on a logic change model, constructed with literature data and validated by an expert group through a DELPHI method : the rehabilitation model.
This intervention was designed to be implemented pragmatically in the centers according local habits and is currently being evaluated in several distinct hospital contexts under the name of "PROADAPT pilot study" in different tumor contexts thanks to a grant from the Regional Health Agency of Rhône-Alpes Auvergne region.
PROADAPT intervention is planned to be evaluated in 4 tumor models inducing complex medico-surgical procedures considered at high risk of geriatric deconditioning. They have the same primary objectives in order to be evaluated into a meta-analysis. Results will be used to test the validity of the rehabilitation model. Therefore, it is a study reaching the goal of the population health intervention research.
The purpose of the PROADAPT-ovary/EWOC-2 study is to evaluate the impact of PROADAPT on patient's post-surgical outcomes in patients ≥ 70 years old with an advanced ovarian cancer (AOC).
Read the 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 associated with increased risk of co-morbidities as well as a decline of functional reserve of multiple organ systems, eventually leading in the context of the disease-and/or the treatment-related stress to functional deconditioning or organ failure.
Surgery or complex medico-surgical procedures can be considered as one proof-of principle of such risks, since major cancer surgery the older population is at higher risk of morbi-mortality and unplanned hospitalization for geriatric events1.
In order to reduce complications after surgery, prehabilitation has often been considered, and 71% of the surgeons would accept a 4 weeks delay before surgery to improve patients' outcomes if shown to be beneficial2. However, the actual level of evidence depends on the interventions: high for pre-operative nutrition3, but low for physical exercise, due to heterogeneous programs with often bad adherence4. In addition, geriatric validated interventions, in order to prevent iatrogenic event, may be added in a multi-interventional model of intervention.
- Conditions
- Ovarian Cancer, Surgery
- Being tested
- PROADAPT program
- Keywords
- Cytoreductive surgery, Older, Senior adult, Prehabilitation
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROADAPT programBehavioural
- A pre-intervention activity by telephone follow-ups every week for 12 weeks and then every month.
- Pre-operative physical training including strength, endurance and breathing exercises.
- A nutrition activity.
- An activity to educate patients (on nutrition, exercise).
- The implementation of standardised intervention procedures, established in agreement with the surgeons' representatives.
- A pharmaceutical drug conciliation activity: optimization of the patient's different treatments with pharmaceutical expertise.
- A transition activity from the hospital to the home, and a telephone follow-up up to 12 weeks after the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Control arm | No intervention | Patients treated according current practice of the inclusion center. If interventions are implemented locally (geriatric assessment, nutrition, physical activity) they may be proposed to the patient. |
| Intervention arm : PROADAPT program | Experimental | Patients benefiting from the PROADAPT (interventional arm) program. Receives: Behavioral: PROADAPT program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Superiority for post-treatment complication grade≥3
- Superiority for post-treatment complication grade≥3 according the NCI-CTC-v4 (Common Terminology Criteria : CTC) at 30 days
Measured: At 30 days post-treatment
Superiority of HRQOL on the dimensions
Superiority of HRQOL on the dimensions: Mobility, burden of illness, emotional and physical functioning, fatigue, at 3 months
Measured: At 3 months
Secondary outcomes (4)
Post-operative morbidity according Clavien-Dindo classification at 30 and 90 days
Clavien Dindo classification consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V). The introduction of the subclasses a and b allows a contraction of the classification into 5 grades (I, II, III, IV and V) depending on the size of the population observed or the of the focus of a study.
Complications that have the potential for long-lasting disability after patient's discharge (e.g.: paralysis of a voice cord after thyroid surgery) are highlighted in the present classification by a suffix ("d" for disability). This suffix indicates that a follow-up is required to comprehensively evaluate the outcome and related long-term quality of life.
Measured: At 30 and 90 days
Therapeutic strategy (treatment plan completion rate)
A complete therapeutic strategy consists of a complete cytoreductive surgery (CC0) 6 courses of chemotherapy at least in total, either in neo-adjuvant or in adjuvant setting, with at least 2 courses after surgery.
Measured: 2 years
Progression free survival
Progression-free survival (PFS) is defined as the time from random assignment to disease progression or death from any cause.
Measured: 2 years
Overall survival
Overall survival is defined as the time from randomization to death from any cause
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start3 Jun 2021
- Primary completion3 Jun 2027 (estimated)
- Study completion3 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 292 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04284969
- Sponsor's protocol ID
- 69HCL18_0359
- Status last verified
- Nov 2025
- First submitted
- 24 Feb 2020
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehabilitation & Rehabilitation in Oncogeriatrics: Adaptation to Deconditioning Risk and Accompaniment of Patients' Trajectories-ovary/Elderly Women With Ovarian Cancer-2, a GINECO Multicenter Randomized Study (PROADAPT-ovary/EWOC-2)
- ClinicalTrials.gov ID
- NCT04284969
- Acronym / sponsor ID
- 69HCL18_0359
- Conditions
- Ovarian Cancer, Surgery
- Keywords
- Cytoreductive surgery, Older, Senior adult, Prehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 292 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 3 Jun 2027 (estimated)
- Study completion
- 3 Mar 2029 (estimated)
- First posted
- 26 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 published data (Figure).
It consists in: 1) before surgery: a prehabilitation of the patients including a nutritional, physical and educational preparation; 2) during the hospitalization for surgery: an optimisation of their treatments through a pharmaceutical conciliation, educational interventions, standardization of surgical procedures and enhanced rehabilitation after surgery; 3) bridging and post-discharge interventions for hospital-to-home transition.
This intervention is based on a logic change model, constructed with literature data and validated by an expert group through a DELPHI method : the rehabilitation model.
This intervention was designed to be implemented pragmatically in the centers according local habits and is currently being evaluated in several distinct hospital contexts under the name of "PROADAPT pilot study" in different tumor contexts thanks to a grant from the Regional Health Agency of Rhône-Alpes Auvergne region.
PROADAPT intervention is planned to be evaluated in 4 tumor models inducing complex medico-surgical procedures considered at high risk of geriatric deconditioning. They have the same primary objectives in order to be evaluated into a meta-analysis. Results will be used to test the validity of the rehabilitation model. Therefore, it is a study reaching the goal of the population health intervention research.
The purpose of the PROADAPT-ovary/EWOC-2 study is to evaluate the impact of PROADAPT on patient's post-surgical outcomes in patients ≥ 70 years old with an advanced ovarian cancer (AOC).
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 associated with increased risk of co-morbidities as well as a decline of functional reserve of multiple organ systems, eventually leading in the context of the disease-and/or the treatment-related stress to functional deconditioning or organ failure.
Surgery or complex medico-surgical procedures can be considered as one proof-of principle of such risks, since major cancer surgery the older population is at higher risk of morbi-mortality and unplanned hospitalization for geriatric events1.
In order to reduce complications after surgery, prehabilitation has often been considered, and 71% of the surgeons would accept a 4 weeks delay before surgery to improve patients' outcomes if shown to be beneficial2. However, the actual level of evidence depends on the interventions: high for pre-operative nutrition3, but low for physical exercise, due to heterogeneous programs with often bad adherence4. In addition, geriatric validated interventions, in order to prevent iatrogenic event, may be added in a multi-interventional model of intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –Patients treated according current practice of the inclusion center. If interventions are implemented locally (geriatric assessment, nutrition, physical activity) they may be proposed to the patient. |
| Intervention arm : PROADAPT program | Experimental | Behavioral: PROADAPT programPatients benefiting from the PROADAPT (interventional arm) program. |
Who may qualify
- Ages
- 70 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PROADAPT program* A pre-intervention activity by telephone follow-ups every week for 12 weeks and then every month. * Pre-operative physical training including strength, endurance and breathing exercises. * A nutrition activity. * An activity to educate patients (on nutrition, exercise). * The implementation of standardised intervention procedures, established in agreement with the surgeons' representatives. * A pharmaceutical drug conciliation activity: optimization of the patient's different treatments with pharmaceutical expertise. * A transition activity from the hospital to the home, and a telephone follow-up up to 12 weeks after the surgery. | Behavioural | Intervention arm : PROADAPT program |
Primary outcome
Superiority for post-treatment complication grade≥3
Time frame: At 30 days post-treatment
• Superiority for post-treatment complication grade≥3 according the NCI-CTC-v4 (Common Terminology Criteria : CTC) at 30 days
Superiority of HRQOL on the dimensions
Time frame: At 3 months
Superiority of HRQOL on the dimensions: Mobility, burden of illness, emotional and physical functioning, fatigue, at 3 months
4 secondary outcomes
Post-operative morbidity according Clavien-Dindo classification at 30 and 90 days
Time frame: At 30 and 90 days
Therapeutic strategy (treatment plan completion rate)
Time frame: 2 years
Progression free survival
Time frame: 2 years
Overall survival
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Noual BAKRIN, MD contact
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROADAPT program in people with Ovarian Cancer and Surgery, run by Hospices Civils de Lyon at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claire FALANDRY, PR (4.78.86.32.87 ext. +33, claire.falandry@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Superiority for post-treatment complication grade≥3 (time frame: At 30 days post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.