Ovarian CancerNCT02163720
Ovarian Cancer Treatment Platinum-sensitive Relapse - Cohort Study (PROSPECTYON)
An observational study of Ovarian Cancer, run by ARCAGY/ GINECO GROUP at 33 sites in France.
Trial summary
The French cooperative group GINECO proposes to implement an observational study to describe a real situation, in daily practice tolerance and methods of administration of trabectedin (Yondelis®)-Pegylated liposomal doxorubicin(Caelyx)®, in ovarian platinum sensitive cancer relapse. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Yondelis®-Caelyx®
- How many people
- 101 participants
- Where
- 33 sitesFrance
- Study dates
- 10 Jul 2014to 18 Sep 2018
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with epithelial ovarian cancer, fallopian tube or peritoneal with treatment receiving in relapse platinum-sensitive
Who may be able to join
- Patients aged 18 years and over,
- Patients with an epithelial ovarian cancer, fallopian tube or peritoneal who will receive Yondelis®-Caelyx® in relapse platinum-sensitive
- Patients should be informed of the study orally and should not have any objection their data to be processed
Who cannot join
- Patient participation in a clinical trial
- Patient non-affiliated to a social security scheme.
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
France33 sites
Centre de Radiothérapie et d'Oncologie
Agen
Clinique de l'Europe
Amiens
ICO Paul Papin
Angers, 49100
Hôpital de la Côte Basque
Bayonne, 64100
Hôpital jean Minjoz
Besançon
Clinique Tivoli
Bordeaux
Hôpital Fleyriat
Bourg-en-Bresse
Hôpital Morvan - Centre Hospitalier Universitaire
Brest, 29200
Cabinet d'Oncologie - Hôpital Privé Sainte Marie
Chalon-sur-Saône, 71100
Centre Hospitalier de Cholet
Cholet
Hôpital Privé Drôme Ardèche - Clinique Pasteur
Guilherand-Granges, 07500
Hôpital Louis Pasteur
Le Coudray, 28630
Centre Oscar Lambret
Lille
Centre Hospitalier Universitaire Dupuytren
Limoges, 87042
CHU Dupuytren
Limoges
Centre Léon Bérard
Lyon, 69373
institut Paoli Calmette
Marseille
Centre Azuréen de Cancérologie
Mougins
Centre d'oncologie de Gentilly
Nancy
Centre Hospitalier Régional
Orléans
Hôpital Tenon
Paris, 75020
Hôpital de la Milétrie - Centre Hospitalier Universitaire de Poitiers - Pôle Régional de Cancérologie
Poitiers, 86021
Clinique Courlancy
Reims, 51100
Institut Jean Godinot
Reims
Clinique Armoricaine de Radiologie
Saint-Brieuc
Clinique de l'Alliance
Saint-Cyr-sur-Loire
ICO Centre René Gauducheau
Saint-Herblain, 44805
Clinique de l'Union
Saint-Jean, 31240
GHPSO - Site Senlis
Senlis, 60309
Centre de Radiothérapie - Clinique Sainte-Anne
Strasbourg, 67000
Clinique Saint Jean
Toulon
Institut Claudius Regaud
Toulouse, 31059
Institut de Cancérologie Gustave Roussy
Villejuif, 94805
About this study
Official title: Non Interventional Study Dealing With the Use of Trabectedin (Yondelis®)-Pegylated Liposomal Doxorubicin (Caelyx®) in Patient With Platinum-sensitive Relapse
The French cooperative group GINECO proposes to implement an observational study to describe a real situation, in daily practice tolerance and methods of administration of trabectedin (Yondelis®)-Pegylated liposomal doxorubicin(Caelyx)®, in ovarian platinum sensitive cancer relapse.
Read the detailed description
Population : Patients aged 18 years and older with an epithelial ovarian cancer, fallopian tube or primary peritoneal with platinum-sensitive recurrent witch it was decided to initiate a treatment with trabectedin (Yondelis®)-Pegylated liposomal doxorubicin(Caelyx)®.
- Conditions
- Ovarian Cancer
- Being tested
- Yondelis®-Caelyx®
- Keywords
- ovarian cancer, fallopian tube or primary peritoneal, relapse, platinum-sensitive, Yondelis®-Caelyx®
- Medical subject headings
- Ovarian Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yondelis®-Caelyx®Drug
Also called Observation of Yondelis®-Caelyx® administration
Observation of Yondelis®-Caelyx® administration
| Study group | Role | What they receive |
|---|---|---|
| Yondelis®-Caelyx®-relapse ovarian cancer | Yondelis®-Caelyx®-relapse ovarian cancer Receives: Drug: Yondelis®-Caelyx® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the proportion of patient partially versus fully platinum-sensitive in relapse ovarian cancer
To assess patient safety and the tolerance of Yondelis®-Caelyx® administered regarding the daily practice of the oncologist.
Measured: Patient will be followed during 12 months
Secondary outcomes (6)
Choice of treatment
Describe the reason why treatment by trabectedin and doxorubicine combination was initiated (ex : number of patients with previous intolerance to platinum as allergic reaction, residual peripherical neuropathy, alopecia; availability of the combination yondelis-caelyx in the treating site; number of sites where the yondelis-caelyx combination is the reference treatment)
Measured: at baseline
Characteristics of the population registered
Describe the population that will be registered
Measured: at baseline
Evaluation of the modality of use of Yondelis®-Caelyx®
Describe the way how treatment by Yondelis®-Caelyx® is administered in the daily practice for each patient (Initial dosage of caelyx and yondelis, number of cycles administered for each treatment , dose reductions occurence and reasons)
Measured: during treatment (expected period = 6 months)-As it is an non interventionnal study, treatment period corresponds to the routine practice of each investigator
Safety according to CTCAE v4.03 criteria
To assess patient safety and the tolerance of Yondelis®-Caelyx® administered regarding the daily practice of the oncologist.
Measured: Patient will be followed during 12 months
Evaluation of clinical benefit
Evaluation of clinical benefit will be performed during the physical examination at baseline and during the treatment
At baseline : describe the number of patients how present the following related symptom disease : weight loss, ascites, abdominal pain, constipation, fatigue, occlusive syndrome
Then, describe the number of patients how presented and improvement or a degradation of theses related symptom disease during the treatment
Nota Bene : this cohort study is strictly observational and must represent the daily practice. No indications must be given regarding the frequency of the physical examination
Measured: baseline and during treatment (expected period of treatment = 6 months). As it is an non interventionnal study, treatment period corresponds to the routine practice of each investigator.
Efficacy of treatments
Evaluate the efficacy of Yondelis®-Caelyx® in terms of progression-free survival (PFS), Overall Survival (OS), response to treatment.
Measured: during treatment and follow up period (maximum of 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2014 (estimated)
- Study start10 Jul 2014
- Primary completionMar 2017
- Study completion18 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- ARCAGY/ GINECO GROUP
- Sponsor type
- University, hospital or other
- Collaborators
- PharmaMar
- Responsible party
- Sponsor
- Investigators
- Frédéric SELLE, MD, Principal investigator, Hôpital Tenon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02163720
- Sponsor's protocol ID
- PROSPECTYON (GINECO-OV229)
- Status last verified
- Sep 2020
- First submitted
- 28 May 2014
- Last updated
- 30 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Selle F, Heudel PE, Hardy-Bessard AC, Pozet A, Meunier J, Gladieff L, Lotz JP, Provansal M, Augereau P, Berton D, Bonichon-Lamichhane N, Orfeuvre H, Pautier P, Kalbacher E, Tazi Y, Spaeth D. GINECO Prospective Non-interventional PROSPECTYON Study: Trabectedin Plus Pegylated Liposomal Doxorubicin for Platinum-sensitive Recurrent Ovarian Cancer. Anticancer Res. 2020 Jul;40(7):3939-3945. doi: 10.21873/anticanres.14385.
PubMed 32620635
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Interventional Study Dealing With the Use of Trabectedin (Yondelis®)-Pegylated Liposomal Doxorubicin (Caelyx®) in Patient With Platinum-sensitive Relapse
- ClinicalTrials.gov ID
- NCT02163720
- Acronym / sponsor ID
- PROSPECTYON (GINECO-OV229)
- Conditions
- Ovarian Cancer
- Keywords
- ovarian cancer, fallopian tube or primary peritoneal, relapse, platinum-sensitive, Yondelis®-Caelyx®
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- ARCAGY/ GINECO GROUPUniversity, hospital or other
- Collaborators
- PharmaMar
- Study start
- 10 Jul 2014 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- 18 Sep 2018 (actual)
- First posted
- 16 Jun 2014 (estimated)
- 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.
The French cooperative group GINECO proposes to implement an observational study to describe a real situation, in daily practice tolerance and methods of administration of trabectedin (Yondelis®)-Pegylated liposomal doxorubicin(Caelyx)®, in ovarian platinum sensitive cancer relapse.
Detailed description
Population : Patients aged 18 years and older with an epithelial ovarian cancer, fallopian tube or primary peritoneal with platinum-sensitive recurrent witch it was decided to initiate a treatment with trabectedin (Yondelis®)-Pegylated liposomal doxorubicin(Caelyx)®.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yondelis®-Caelyx®-relapse ovarian cancer | – | Drug: Yondelis®-Caelyx®Yondelis®-Caelyx®-relapse ovarian cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with epithelial ovarian cancer, fallopian tube or peritoneal with treatment receiving in relapse platinum-sensitive
Key inclusion criteria (3 listed)
- Patients aged 18 years and over,
- Patients with an epithelial ovarian cancer, fallopian tube or peritoneal who will receive Yondelis®-Caelyx® in relapse platinum-sensitive
- Patients should be informed of the study orally and should not have any objection their data to be processed
Key exclusion criteria (2 listed)
- Patient participation in a clinical trial
- Patient non-affiliated to a social security scheme.
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 |
|---|---|---|
| Yondelis®-Caelyx®Also: Observation of Yondelis®-Caelyx® administrationObservation of Yondelis®-Caelyx® administration | Drug | Yondelis®-Caelyx®-relapse ovarian cancer |
Primary outcome
Evaluate the proportion of patient partially versus fully platinum-sensitive in relapse ovarian cancer
Time frame: Patient will be followed during 12 months
To assess patient safety and the tolerance of Yondelis®-Caelyx® administered regarding the daily practice of the oncologist.
6 secondary outcomes
Choice of treatment
Time frame: at baseline
Characteristics of the population registered
Time frame: at baseline
Evaluation of the modality of use of Yondelis®-Caelyx®
Time frame: during treatment (expected period = 6 months)-As it is an non interventionnal study, treatment period corresponds to the routine practice of each investigator
Safety according to CTCAE v4.03 criteria
Time frame: Patient will be followed during 12 months
Evaluation of clinical benefit
Time frame: baseline and during treatment (expected period of treatment = 6 months). As it is an non interventionnal study, treatment period corresponds to the routine practice of each investigator.
Efficacy of treatments
Time frame: during treatment and follow up period (maximum of 12 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
- Results publication: PubMed 32620635Selle F, Heudel PE, Hardy-Bessard AC, Pozet A, Meunier J, Gladieff L, Lotz JP, Provansal M, Augereau P, Berton D, Bonichon-Lamichhane N, Orfeuvre H, Pautier P, Kalbacher E, Tazi Y, Spaeth D. GINECO Prospective Non-interventional PROSPECTYON Study: Trabectedin Plus Pegylated Liposomal Doxorubicin for Platinum-sensitive Recurrent Ovarian Cancer. Anticancer Res. 2020 Jul;40(7):3939-3945. doi: 10.21873/anticanres.14385.
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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. This study is not recruiting at the moment.
Frédéric SELLE, MD principal investigator
Hôpital Tenon
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by ARCAGY/ GINECO GROUP at 33 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 30 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the proportion of patient partially versus fully platinum-sensitive in relapse ovarian cancer (time frame: Patient will be followed during 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02163720, which also lists 1 linked publication.
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 30 Sep 2020.